Take note - Share price at posting $1.85
From the Q1 USA Webcast:
2021 Q2 / Q3 Company Expectations:
Remestemcel
1. CBER review team (OTAT) - meeting to get agreement on acceptable manufacturing ( including potency assay validation )
2. Meeting with the FDA about results for patients under 65 ARDS
3. Still working closely with Novartis onDevelopment / manufacturing / distribution..... with initial focus on development for ARDS.
Rexlemestrocel
1. Meeting with FDA (USA approvals) and EMA (Europoean approvals) regarding pathway to approval for Chronic Lower Back Pain
2. Meeting with FDA (USA approvals) regarding pathway to approval for Chronic Heart Failure based on reduction in mortality and morbidity from phase 3 trial.
By 30th September 2021 we should hear :
- If FDA think mesoblasts' new approach to potency assays is acceptable, and if so expect submission of an immediate BLA application for approval ( Approval meeting would occur in 2022 )
- What FDA wants to see in order to approve Covid ARDS ( Confirmatory trial / phase 3 / phase 4 or EUA ) - Potentially all funded by Novartis
- What FDA and EMA want to see for approval of Lower Back Pain ( Confirmatory trial-which was always the plan / phase 3 / phase 4 or EUA )
- What FDA want to see for approval for Heart Failure ( Confirmatory trial / phase 3 / phase 4 or EUA )
- Confirmation of the Novartis agreement status
Further to that I would expect to hear confirmation on the Novartis licensing and collaboration agreement shortly - dare I say definitely by the 30th September. That deal will fund all further COVID ARDS trial requirements, and if the FDA meeting is scheduled by 30th September, I think Q4 2021 we will have confirmation and initiation of Novartis' first Remestemcel trial. ( assuming they don't get EUA or Phase 4 approval )
Novartis for Chronic Heart Failure?I hear some people speculating that the reason for the delay in closing conditions is a possible renegotiation for CHF also. I think it's highly unlikely part of the closing conditions for COVID ARDS was allowing Novartis to renegotiate for an entirely different product and different condition. SI mentioned in the webcast that the first step of the agreement was pulmonary and respiratory. This does not include the Heart. They are keeping their options open here, and I think that is a smart move. They had so much success in the phase 3 trial - it is entirely possible they get approved at the next meeting.
As mentioned in the webcast, when Mesoblast get the dataset they analyse, generate statistical data with interpretation, pass the data to Novartis who do the same thing. This has been repeatedly mentioned as one of the closing conditions, and I think they are still going down that path at present. If you stand back and look at all the confounding factors in the trial... different age groups, 6 or 7 major changes to standard of care, the other experimental treatments that have not even been listed, length of hospitalization prior to treatment, length on ventilation before / after treatment, Biomarkers before / during / after treatment, comorbidities, cell batch potency assays....... there is an enormous amount of data that Novartis need to go through to really make the conclusion.... ok it works...... take our money. IMO I see no room at all for an expansion into a completely different area as part of this contract. From memory the CHF results were not out when Novartis made the agreement announcement, and that was after doing 6 months of due diligence on the COPD /COVID Emergency Use results. I think a further Novartis agreements is more likely to occur around Crohns and Colitis, given it's the same product and pilot data is due to read out shortly. If that is the case, then I hope meso go in alone or 50/50.
GVHD - what has changed?Mesoblasts' tune has moved into potency assays in this area, and getting agreement from FDA on mesoblasts' approach. I think they are using new data here generated from the COVID trial that would link potency assays along with cause and biomarker effect in the under 65's. As they mentioned they are in discussions with Novartis for the Development of COVID ARDS.... so I have a hunch that Novartis may be providing some input into either which assays to use, or how to present the data for approval. Time will tell, but this sounds like it may well be "back from the dead", and ready for BLA and round 2 with the ODAC.
Grunenthal Milestone Payments..Meso said they will discuss with the FDA and then take the data over to the EMA to see if there is agreement on trial design. Grunenthal need to pay USD 20 million when EMA approve the phase 3 trial.
So this is looking to be an exciting year indeed. 4 Products with potential to get approved, and a 5th Crohns to read out that is expected to have good results, JCR pharma are going to be treating more patients, Grunenthal may give a cash injection...
Needless to say..... any one of those 4 get phase 4 approval.....ka..... Boooom !
GL
DYOR
(20min delay)