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Stock NameTickerPrice (20min delay)15 Dec - Revascor shows 60% reduction in mortality!
Talks for approval and commercialisation are under way		Eastern Time Now
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Mesoblast (AU)ASX:MSB1.095/17/2024 19:37:55
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Mesoblast (US)NASDAQ:MESO7.35
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Remestemcel-L
Revascor
MPC-06-ID
ODAC REPLAY -
https://hotcopper.com.au/posts/46540487/single

Rem-L MOA -
https://hotcopper.com.au/posts/46535806/single		Ignore post link
https://hotcopper.com.au/threads/msb-trading-2020-a-new-dawn.5553688/page-845?post_id=46584156
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<-- 2021 hidden
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WHAT'S NEXT FOR MESOBLAST?

1) C-19 ARDS 60% READOUTS - EOY 20
2) Peds AGVHD Type A meeting for Accelerated Approval - Early Nov
3) CHF/CLBP Readouts - Q4,CY20
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Q4 2020
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DateProductHeadlineDetails/EventSource
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RYONCIL COMMERCIAL LAUNCH
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MPC-150-IMPotential partnering deal for MSB's congestive heart failure product@ddwn, https://hotcopper.com.au/posts/44627079/single
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Potential partnering deal for MSB's chronic discogenic lower back pain (CLBP) product@ddwn, https://hotcopper.com.au/posts/44627079/single
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Grunenthal updates, Tasly updates, Takeda updates and milestone payments@ddwn, https://hotcopper.com.au/posts/44627079/single
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Heart Failure and CLBP readout, approximate completion of enrollment Covid-19
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Upcoming/Current Events
1a. Novartis Partnership - ANNOUNCED
1. COVID-19 trial 45% interim readout - CONTINUE
2. Ryoncil ped AGVHD Type A meeting minutes
3. COVID-19 trial 60% interim readout
3a. FAST TRACK DESIGNATION (for C-19 ARDS) - ANNOUNCED 02/12
4. Crohn's trial news - 22 Oct
5. COVID-19 trial 100% readout
6. Revascor for CHF readout - 15/12 ANN - 60% REDUCTION IN MORTALITY
7. Rexlemestrocel for CLBP readout
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December 2020
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DateProductHeadlineDetails/EventSource
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WE ARE HERE
WEEK 1
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15 DecCHF - 60% REDUCTION IN MORTALITYTop line results from the CHF 537 patient trial is out -

1. Patients with advanced chronic heart failure who received a single endomyocardial treatment with rexlemestrocel-L on top of maximal therapies had 60% reduction in incidence of heart attacks or strokes and 60% reduction in death from cardiac causes when treated at an earlier stage in the progressive disease process.

2. Although pri endpoint of non-fatal decompensated HF was not met, the reduction in mortality (60% reduction vs current SOC 20% reduction)

3. Significant reduction in the incidence of non-fatal ischemic major adverse cardiac events (MACE) due to a heart attack (myocardial infarction, MI) or stroke (cerebrovascular accident, CVA) by 60% relative to controls in the total population of 537 patients (p=0.002); reduction in MACE was seen consistently across both New York Heart Association (NYHA) class II or III populations and irrespective of whether the underlying cause of heart failure was ischemic or non-ischemic

4. Significant reduction in death from all cardiac causes (CV death) in the 206 heart failure patients with NYHA class II disease by 60% relative to controls (p=0.037), which was evident in both ischemic and non-ischemic subgroups

5. Prevention of NYHA class II patients progressing to CV death rates of NYHA class III patient (p=0.004); in contrast, NYHA class II patients on maximal therapy in the control group progressed to CV death rates of NYHA class III patients after a mean period of 20 months of disease stability

6. Significant reduction in the composite of the pre-specified CV death or ischemic MACE outcomes in heart failure patients with NYHA class II disease by 55% relative to controls (p=0.009)
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02 DecBell Potter Update, thanks @Anjo-Rochhttps://hotcopper.com.au/posts/49288451/single
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02 DecWhat is Fast Track?Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. Fast Track addresses a broad range of serious conditions.

Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one. AIDS, Alzheimer’s, heart failure and cancer are obvious examples of serious conditions. However, diseases such as epilepsy, depression and diabetes are also considered to be serious conditions.

Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
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02 DecFAST TRACK DESIGNATION GIVEN
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01 Dec@stanjupiter editorialKey Takeaways
1. Rem-L is unlike any other in the fight against C-19 ARDS precisely because its multi-modal in its MOA unlike a lot of single MOA candidates
2. There is blood on the FDA's hands for not getting Rem-L out for peds AGVHD quick enough
3. In Ruxolitinib, the edema is still there in the 'after' photo
4. MSB is the company at the right place and the right time		https://hotcopper.com.au/posts/49277039/single
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November 2020
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DateProductHeadlineDetails/EventSource
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29 Nov@batmansdaughter TA on current state of playKey Takeaways
1. Vanguard buying ~3.1m shares
2. 25sma has crossed over 200sma
3. Current shares on loan - 53m (as of 24 Nov), 49m (as of 30 Nov)
4. MSB is currently outperforming XJO		https://hotcopper.com.au/posts/49224378/single

https://hotcopper.com.au/posts/49239253/single
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WEEK 3
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20 NovNOVARTIS PARTNERSHIP ANNOUNCED
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19 NovThe MSB BackstoryOriginally posted Nov 16 on the-scientist website (thanks @techfan20!)

LINK: https://www.the-scientist.com/the-marketplace/the-msc-regeneration-orchestrator-68145
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17 Nov@smartspec's musings on the current state of playPre reading here -> https://hotcopper.com.au/threads/meso-action-tonight.5360399/page-3013?post_id=48752903 https://hotcopper.com.au/posts/48918362/single
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October 2020
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DateProductHeadlineDetails/EventSource
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WEEK 4
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29 OctLeftYahoo's post on bamlanivimab"Eli Lilly announced that they are halting the testing of bamlanivimab in patients with C-19 who are hospitalized. Bamlanivimab is an anti-spike protein mAb designed to neutralize the C-19 virus. I had mentioned it in a post below as a potential competitor to rem-L. That's no longer the case since it will not be used in ICU patients. Lilly is continuing to test it in patients at high risk for complication who have recently developed a positive PCR test for the virus but have not yet become ill enough to require admission to the hospital. Of note, bamlanivumab was used on Gov. Chris Christie and the medication is similar to the Regeneron mAb cocktail that was administered to President Trump. Perhaps they help if given very early in the illness. Perhaps they may prevent the illness in high risk workers and patients who are asymptomatic. But the door remains wide open for a medication like remestemcel-L that can treat patients with ARDS and advanced disease. There remains a great opportunity and need for a medicine of last resort. And for a medicine for the illness related to C-19 suffered by the children."

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22 OctCrohn's Trials AnnouncedMesoblast Limited (ASX:MSB; Nasdaq:MESO), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that a randomized, controlled study of remestemcel-L delivered by an endoscope directly to the areas of inflammation and tissue injury in up to 48 patients with medically refractory Crohn’s disease and ulcerative colitis has commenced at Cleveland Clinic. Mesoblast Chief Medical Officer Dr Fred Grossman said: “Inflammation of the gut in Crohn’s disease and ulcerative colitis closely resembles the most severe manifestation of advanced-stage, lifethreatening acute graft versus host disease (aGVHD). Mesoblast’s objective is to confirm the potential for remestemcel-L to induce luminal healing and early remission in a wider spectrum of diseases with severe inflammation of the gut, in addition to steroid-refractory aGVHD.”https://hotcopper.com.au/threads/remestemcel-controlled-study-in-crohns-ulcerative-colitis.5702558/
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6 Oct@smartspec's commentary on the state of play hereWell thought out response, worth a read!https://hotcopper.com.au/posts/47869606/single
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2 OctCRL given, Type A meeting requested for "Accelerated Approval"
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1 OctRemestemcel-L ANN PENDING, TH till October 5
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September 2020
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DateProductHeadlineDetails/EventSource
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WEEK 5Potential Events
1. Ryoncil peds AGVHD Approval (PDUFA date of 30th Sept)
2. Ryoncil Adult sR AGVHD Announcement
3. Manufacturing partnership Announcement



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29 SepRevascorDr Perrin on CHF readouts - 50 days from now (thanks @dachopper)"The first 50 minutes explains the progress that has been made over the last 20 years in the treatment of heart failure, with various stem cell products including some from Mesoblast and culminates in the Doc talking about the Mesoblast phase 3 trial and how it is a trial for product approval to the FDA.

He talks about the data unblinding due in May 2020, and that if there were very positive results, the results would be published around August September 20. ( this was pre-covid )

He also says if it's not very positive that the results would come out in at the American heart association meeting - which is scheduled to be an online event November 13-17 2020.

What can we take out of this? The phase 3 reveal should occur prior to or during the Nov 13 -17th date. ie...... within about 50 days."		https://youtu.be/qCLLLIUkMLE
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29 Sep@stanjupiter piece on MIS-C: GATEWAY INTO PEDIATRIC AUTOIMMUNE AND INFLAMMATORY CONDITIONSDo yourself a favor and read it, its a treasure trove of information on where we're at and the current literature on it.https://hotcopper.com.au/posts/47692901/single
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28 Sepwombat777's recap on ARDS price scenariosRead posts for assumptions and update of numbers:


https://hotcopper.com.au/posts/47518352/single
https://hotcopper.com.au/posts/47543009/single
https://hotcopper.com.au/posts/47543807/single		https://hotcopper.com.au/posts/47677664/single
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26 SepCytokines and C-19 - thanks @Opfan17https://celltrials.org/news/cytokines-offer-clues-msc-therapies-covid-19
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25 SepGVHD - what is it? Thanks @TreedDr Donna Skerrett, the CMO of Mesoblast (from 2005 - 2019) shares about what happens in GVHD
Link to video here -> https://www.youtube.com/watch?v=Y6px9Sd3_sw&feature=emb_logo&fbclid=IwAR1s0zpzHs-fShuS0hlVFPE6mWYZizdWsnsjMaJXxcBHugJ4ke042KXf4yE

**Remember London Bowater? This is her story**		https://hotcopper.com.au/posts/47640105/single
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16 Sep@The Yankee's post on MSB and Heart AttackIn case you missed it (it was posted in the wee hours of the morning)https://hotcopper.com.au/posts/47370207/single
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15 Sep@The Yankee's post on big instos ADDING to their positions"Bottom Line: Funds are smartly accumulating. I expect to see a rise in institutional ownership in MESO (NASDAQ) when 3rd Quarter ownership is reported." - @The Yankee

Some notable entrants

1) Goldman Sachs Group Inc - NEW position of 204,066 MESO ADRs (shares) on 12/08

2) Susquehanna International Group, LLP - INCREASING their position 582% to 158,714 shares on 14/08

3) Qube Research & Technologies Ltd - NEW position of 70,933 shares on 14/08

4) Jefferies Group, LLC - NEW position of 90,000 shares on 14/08

5) Bank of America Corp DE - INCREASING their position 528.90% to 17,647 shares on 14/08

6) Jane Street Group, LLC - INCREASING their position 310.84% to 62,834 shares on 17/08

For the FULL LIST (WHICH IS WAY MORE) click on the link -->
https://hotcopper.com.au/posts/47342969/single
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15 SepMesoblast wins Fierce Pharma award for Biotech Innovation
[Panelists were essentially Big Pharma]		https://www.fiercebiotech.com/sponsored/fierce-innovation-awards-life-sciences-edition-2020-winners-announcement
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14 SepBullish StanceJulia Lee from Burman Invest reiterating a bullish stance on MSB - SwitzerTV 14 Sept 2020 interviewhttps://www.youtube.com/watch?v=hT8SUYM5czs&feature=youtu.be
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13 Sep@otherperspective's Op-Ed on the current state of thingsGreat read on the current state of things, considering the seasonality of the times.https://hotcopper.com.au/posts/47297223/single

https://youtu.be/8UvFhIFzaac
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12 Sep@stanjupiter's post on ARDS FibrosisMust read, very insightful! Too long to summarize here

"My conclusion about steroids in Covid ARDS is this is not competition but greater contrast, not just to these drugs, but our rigorous design of trial and absence of any hype."		https://hotcopper.com.au/posts/47293890/single
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10 Sep@kervio's Bayesian modellingYou gotta check it outhttps://hotcopper.com.au/posts/47244564/single
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2 SepRem-LAUS Ethics ApprovalETHICS APPROVAL TO TREAT C-19 VENTILATED PATIENTS IN AUSTRALIAhttps://hotcopper.com.au/threads/ethics-approval-to-treat-covid-19-patients-in-australia.5600732/
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August 2020
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DateProductHeadlineDetails/EventSource
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WEEK 4Revascor, MPC-06-ID
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31 AugSeekingalpha articleMESOBLAST BEFORE THE PDUFAhttps://hotcopper.com.au/posts/46969922/single
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27 Aug
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26 AugRem-LFIRST IN NATION treatment for MIS-C at MUSC Shawn Jenkins Children's Hospital, thanks @Anjo-Roch“But on the day we administered the first infusion, he still had evidence of cardiac dysfunction. The other worrisome elements of his level of disease at that point were his inflammatory markers. In particular, his D-dimer, which is a marker of coagulation, was very high. And we worry when levels are that high that you’re at very high risk of a serious blood clot.”

Cardiologist Andrew Atz, M.D., chairman of pediatrics at the Medical University of South Carolina, said that after receiving remestemcel-L, K.J.’s markers improved dramatically. “He had very abnormal heart function. But the day of his discharge, his heart function had not only improved but was better than normal.”

K.J.’s D-dimer came down, too, to Eckard’s relief. She called the developments exciting. “I really do think that this product has a potential large impact on MIS-C and perhaps even Kawasaki disease in children.” Kawasaki disease, like MIS-C, causes inflammation throughout the body.

But Atz said that at this point, remestemcel-L is not first-line therapy for MIS-C. “This shows very good promise, and I could imagine this becoming over time, with more research, potentially a first-line treatment. 		https://hotcopper.com.au/posts/46818596/single

https://web.musc.edu/about/news-center/2020/08/25/first-in-nation-treatment-for-mis-c-at-musc-shawn-jenkins-childrens-hospital
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22 AugOlympiaReport on Valuations@taylorstjames summary here -> https://hotcopper.com.au/posts/46789798/single https://theolympiareport.com/2020/08/22/mesoblast-limited-nasdaqmeso-receives-15-89-consensus-pt-from-brokerages.html
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21 AugRicki Lewis article in ipscell.comMesoblast MSCs Quell Peds GvHD; On Road to FDA Approval?https://ipscell.com/2020/08/mesoblast-mscs-quell-pediatric-gvhd-on-road-to-fda-approval/
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19 AugBell Potter raising price target by 22% to $7.30, thanks @Anjo-RochInvestor Note released 18 Augusthttps://hotcopper.com.au/posts/46635697/single
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19 Aug@Stanjupiter postCovers - Microbiome, Crohn's, Steroids, Ruxo in real life.

"I don't think they're competition. I think they're contrast. " - @stanjupiter		https://hotcopper.com.au/posts/46639154/single
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16 AugMesoblast Upside From COVID-19 ARDS And ARDS - @Wombat777's Article on Seeking Alpha ------------------>https://seekingalpha.com/instablog/48409492-wombat777/5485825-mesoblast-upside-from-covidminus-19-ards-and-ards
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15 AugContinued Media exposure on the company! Links as follow -

1) Sydney Morning Hearld - https://www.smh.com.au/business/companies/mesoblast-treatment-gets-us-tick-of-approval-20200813-p55liw.html

2) WCG FDA News - https://webcache.googleusercontent.com/search?q=cache:yVhacK0jq2YJ:https://www.fdanews.com/articles/198563-mesenchymal-stem-cell-therapy-shows-promise-for-treating-severe-covid-19+&cd=2&hl=en&ct=clnk&gl=au&client=opera

3) Fierce Pharma - https://www.fiercepharma.com/pharma/mesoblast-scores-fda-committee-s-backing-for-cell-therapy-despite-some-early-worries

4) The Age - https://www.theage.com.au/business/companies/not-for-the-faint-hearted-covid-crisis-brings-boom-time-for-biotechs-20200813-p55l93.html

5) WSJ - https://www.regmedfoundation.org/2020/08/14/the-treatment-that-could-crush-covid/ 		Advisory Committe for pediatric aGVHD
13/08/2020 AM Session, 8am EST, 10pm AEST

FDA to release Briefing Notes and web address for Ryoncil Adcomm webcast - 11/08/2020 (America Time) link here (when available) - https://www.fda.gov/advisory-committees/oncologic-drugs-advisory-committee/2020-meeting-materials-oncologic-drugs-advisory-committee

Morning Draft Agenda

8am - Call to Order and Introduction of Committee
Conflict of Interest Statement

8.10am - Opening Remarks (FDA)

8.15am - Guest Speaker Presentation (Sally Temple, PhD)

8.55am - Applicant Presentations (Mesoblast)
Introduction to Rem-L (Geraldine Storton)
Manufacturing Process (" ")
Pathophysiology of Acute Graft-versus-Host Disease (Silviu Itescu)
Mechanism of Action of Rem-L in aGvHD (" ")
Potency Assay and Relationship to Clinical Outcomes (" " )

9.20am - FDA Presentation
Product Characterization (Steven Bauer, PhD)

9.45am - Clarifying Questions to Presenters

10.00am - Break

10.10am - Open Public Hearing

10.40am - Questions to the Committee/Committee Discussion

12pm - Lunch		Advisory Committe for pediatric aGVHD, date 13/08/2020 PM Session 1pm EST,
3am AEST (14 August 2020)

FDA to release Briefing Notes and web address for Ryoncil Adcomm webcast - 11/08/2020 (America Time) link here (when available) - https://www.fda.gov/advisory-committees/oncologic-drugs-advisory-committee/2020-meeting-materials-oncologic-drugs-advisory-committee

Afternoon Agenda

1pm - Call to Order and Introduction of Committee
Conflict of Interest Statement

1.10pm - Opening Remarks (FDA)

1.15pm - Applicant Presentations (Mesoblast)
Introduction to Rem-L (Geraldine Storton)
Unmet Need in sR-aGvHD (Joanne Kurtzberg, MD)
Remestemcel-L Clinical Efficacy and Safety (Fred Grossman, DO)
Clinical Perspective (Joanne Kurtzberg, MD)

2.00pm - FDA Presentation
Clinical Evidence (Kristin Baird, PhD)

2.45pm - Clarifying Questions to Presenters

3.15pm - Break

3.30pm - Open Public Hearing

4.00pm - Questions to the Committee/Committee Discussion

5pm - Adjournment
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14 AugRem-L MOA and Ruxolitinib, thanks @taylorstjamesA short primer on Rem-L and also mentions about ruxolitinibhttps://hotcopper.com.au/posts/46535806/single
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14 Augrem-LODAC Votes 9-1 to recommend approval of rem-L for peds sr-agvhdhttps://hotcopper.com.au/documentembed?id=uOMxKKzFkiWRTLKhOROKAxjvSTYP5wi1zxGZreR7ke92GA%3D%3D
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12 AugH.C. Wainwright Investor UpdateLong article too, link here --> https://hotcopper.com.au/posts/46519859/single
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12 AugTanushree Jain (Bell Potter) Investor UpdateArticle quite long - link here -> https://hotcopper.com.au/threads/bp-update-tanu-gltah.5552860/?post_id=46492132
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11 AugCantor Fitzgerald's 10 Aug Investor update (thanks @Anjo-Roch)After reviewing the briefing materials, we think this concern is valid, but we believe that MESO has: 1) the necessary data in place to address the FDA's concerns regarding product quality, manufacturing and processes, and 2) the clinical data needed to support approval for Ryoncil as a treatment in children with steroid-refractory acute graft versus host disease (SR-aGVHD). We think that Ryoncil could still be approved on its PDUFA date: 1) if MESO is able to make convincing arguments that address the AdCom's concerns, and 2) depending on how urgently the AdCom feels there is a need for something to treat pediatric SR-aGVHD.

We believe that MESO has the necessary data in place to address any FDA concerns regarding product quality, manufacturing and processes. MESO has potency assays and experience from clinical trials to correlate this potency to measurable clinical outcomes. The manufacturing process of CAR-T therapy, which is autologous, is more likely to lead to heterogeneous cells rather than the manufacturing process for MSCs. NVS (NC) had experience from 250 patients by the time it received approval from the FDA, while MESO has clinical data from three studies which covered over 300 pediatric patients with aGvHD, as well as safety information across several hundred more patients in different indications, which provides it more experience with the cells.

In addition to looking at the adequacy of the design of Protocol MSB-GVHD001, we would note that today's materials also include data from Protocol 275 and subgroup analysis of Protocol 280. We have previously underscored the possibility that the FDA would consider additional supportive data for Ryoncil, and we think the inclusion of this data in the briefing documents further supports the clinical effectiveness of Ryoncil. As we also expected, one question included in the documents is on whether an additional trial may be required for approval in pediatric SR-aGVHD. We continue to believe that an additional trial will not be needed for pediatric approval, though we think a post-market study/more work may be needed for an approval in adults.

After reviewing the briefing materials we continue to expect Ryoncil to be approved for pediatric patients. We think MESO will be able to address the concerns that were raised in the briefing materials. The topics of discussion were already anticipated by the company, and MESO has been preparing for the AdCom. Since there are no safety issues and no alternative treatments for children with SR-aGVHD, we think the unmet need will drive the FDA to approve Ryoncil. If approved, Ryoncil will be the first allogeneic stem cell product to be launched into the U.S. market. We would also note that the FDA has approved CAR T therapies that have more safety and manufacturing issues than Ryoncil. Finally, in the PM briefing document the FDA did note that is "has considered single-arm trials to support a marketing approval in instances where there are no available therapies that would be considered standard of care, where the effect of response is presumed to be attributable to the investigational product."		https://hotcopper.com.au/posts/46461172/single
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11 AugSummary of thoughts on "Manufacturing" and "Addressing Protocol 275, 280 and GVHD-001"@Anjo-Roch ->
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08 AugThe Yankee's post - re comments on the FDA Docket"Remestemcel-L (or Ryoncil) is a life saving therapy for children afflicted with acute Graft vs Host Disease. This treatment was approved by the Japan PMDA in 2016 and is being used in Japan under the name TEMCELL for the last 4 plus years. It has a long proven safety and efficacy profile. It has also been approved in Canada and New Zealand. It is now high time for us in the United States to approve this so children can start using it. Steroids and other drugs are extremely harmful with debilitating side effects and are just not the answer. Please read this wonderful success story of London Bowater, now 11 years old, who in 2017 has been successfully treated by Ryoncil (Remestemcel-L) at Seattle Children's Hospital:

https://pulse.seattlechildrens.org/promising-drug-combination-silences-gvhd/

I strongly urge the FDA and the ODAC to disregard the misinformation campaign being spread by the Lassman Law and Policy firm, which is working for special interest groups from the Pharmaceutical Industry. We as a nation need to do the right thing. And the right thing is to approve Remestemcel-L which has proved safety and efficacy through a rigorous Phase 3 Clinical Trial. Thank you!"

FYI, comments can be submitted here -> https://beta.regulations.gov/document/FDA-2020-N-1539-0022/comment

Since his last post on 07/29 about US institutions buying MESO (ADR's), there are two more that opened new positions on the NASDAQ:
1. AIIQ - AI Powered International Equity ETF
2. UBS Group AG
And VSGX - Vanguard ESG International Stock ETF ETF Shares increased their position nearly 4 freaking fold.		https://hotcopper.com.au/posts/46393300/single
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07 AugCantor Fitzgerald's update (thanks @Opfan17)We remain positive on MESO ahead of the 8/13 AdCom to discuss its BLA for remestemcel-L (Ryoncil) which is an ex-vivo culture-expanded adult human mesenchymal stromal cells [MSCs] suspension for IV infusion. MESO is seeking approval of Ryoncil for the treatment of steroid-refractory acute graft-versus-host disease in pediatric patients (SR-aGVHD). A positive vote in favor of approval for Ryoncil will be an important catalyst for the MESO's stock. Ryoncil's PDUFA date is 9/30. We are expecting an approval on or around that date. MESO is prepared to launch on approval. The unmet need and survival benefit demonstrated with Ryoncil treatment along with its benign safety profile support product approval, in our view. There is no drug available to treat SR-aGvHD for those under 12 in the U.S...https://hotcopper.com.au/posts/46440523/single
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06 Augecoool2's latest postcopied and pasted from Johnny_retahttps://hotcopper.com.au/posts/46359605/single
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06 AugLodge Partners Research Update (published 31 July) thanks @Anjo-Roch"The path to approval for RYONCIL™ is now set. It just needs to get to the finish line.
We have no doubt it will get there. Strong Buy maintained."		https://hotcopper.com.au/posts/46336965/single
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05 AugAMBN article re: EPS = ~12cAnalysts expect that Mesoblast limited (NASDAQ:MESO) will post ($0.12) earnings per share for the current fiscal quarter, according to Zacks. Two analysts have provided estimates for Mesoblast’s earnings, with the highest EPS estimate coming in at ($0.10) and the lowest estimate coming in at ($0.14). Mesoblast reported earnings per share of ($0.21) during the same quarter last year, which would suggest a positive year-over-year growth rate of 42.9%. The firm is scheduled to report its next quarterly earnings results on Thursday, September 3rd.

On average, analysts expect that Mesoblast will report full-year earnings of ($0.58) per share for the current fiscal year, with EPS estimates ranging from ($0.74) to ($0.35). For the next financial year, analysts expect that the company will post earnings of ($0.15) per share, with EPS estimates ranging from ($0.68) to $1.25. Zacks Investment Research’s earnings per share calculations are an average based on a survey of research analysts that that provide coverage for Mesoblast.		https://www.americanbankingnews.com/2020/08/04/analysts-expect-mesoblast-limited-nasdaqmeso-will-announce-earnings-of-0-12-per-share.html
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WEEK 5
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WEEK 4rem-L
20 Jul LONZA PODCAST WITH SI RE: MSC TO TREAT COVID-19 ARDS, availble 5pm AEST (edit: NOW available)		https://lonza.com/news-and-media/a-view-on-podcast
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31 JulMSB/MESOBell Potter upgrades valuation to $6.00Thanks @Anjo-Roch
"All eyes are on Ryoncil’s ADCOM for paediatricSR-aGvHD on 13th Aug’20. Briefing documents from the FDA are expected to beavailable on 11th Aug and will provide insight into questions FDA wants thepanel’s input on. In our view FDA is likely to focus more on manufacturing,product quality, its reproducibility and attributes as they correlate withclinical outcomes and product efficacy rather than safety. We believe thesafety and efficacy (especially survival benefit) demonstrated in 3 separatestudies across 309 children provide strong support for approval. A positivevote in favour of approval of Ryoncil will be a key catalyst for the stock. FDAhas set a PDUFA date of 30th Sep’20 for approval. MSB is prepared to launchon approval with commercial team and inventory in place."		https://hotcopper.com.au/posts/46214947/single
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31 JulMSB/MESOFool.com article - MESO = Strong BuyThanks @stokdoghttps://hotcopper.com.au/posts/46214947/single
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31 JulMSB/MESOEcoool2's post - The Current State of PlayClick on the link to read the post in all its gloryhttps://hotcopper.com.au/posts/46222241/single
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26 JulMSB/MESOEcoool2's post - The Upside is WAY Better.Part I - https://hotcopper.com.au/posts/46078664/single

Part II - https://hotcopper.com.au/posts/46078688/single