@Baza, interesting post thank you. After the shock of missed endpoints and the failure to close the Novartis deal that had been announced. Memory plays tricks so I went back to the November 2020 announcement.
“The closing of the license agreement is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and certain other conditions”
Now it reads
“The agreement remains subject to certain closing conditions, including time to analyze the results from the COVID-19 ARDS trial”
Allow me to be a little guarded about this given the company history of “slippage”. My take on it and therefore timescale on Novartis now.
Original deal was for a lot of committed expenditure for Novartis. Small (relatively) payments upfront, I expect would have started on the expected EUA which as with their payments would have only remained in place with continued good results. Failed endpoint no EUA and no deal. They did not walk away as it costs them nothing. Good PR about data but really in my punter terms, I read it as, trial failed because of changes in the trial, we now know more as we have had plenty of time with the data, but as no EUA yet no deal. Well OTAT will clear path for next trial, which as you outlined can be short sharp and fortunately relatively cheap, might even get NIH to pay for some or all of it. Then EUA as they need this therapy in the medical bag of tricks to treat Covid Ards and with that Novartis.
What I struggle to understand is why the obfuscation in answers.
OTAT date? FDA rushed off their feet, just waiting to be called in, will keep you informed of meeting date when confirmed.
Novartis deal? - We think that once the trial design is confirmed, say end of January, we can start immediately and we should have this done in 3 months as all sides want this either “in or out”. On that timescale we expect April (pick your month) for a EUA. Once we have that we will close on Novartis.
In the meantime we will continue to look for the mega deal on heart and the moving to the next confirmatory trial. (can we use that deal to leverage a early closing for ARDS?)
In the meantime we have sufficient cash to move SRGvHD and Covid Ards through to income generation by the way of approval and EUA.
All this can change of course, but at this moment, time to study the data seems to me a “red herring”
The question I would like to ask SI this morning is this.
”Given that we have had PLENTY of time to look at the data, enough to be confident in the MOA and in a “sweet spot” designed trial that will “blow best available care” out of the water. Are we able to speak to potential alternative partners as Novartis want to wait till granting of EUA? If not then SI are we looking at April (ie give us a realistic time scale)
SI was at great pains to highlight the risks of bio tech investment. That to be honest grated with me. We all know that, what I want is straight answers to straight question as the current Mesoblast investor briefings just through its poor execution and content, add to that risk.
Having said that, I have complete confidence that this will come good, many multiple returns of my investment and the biggest risk is being able to hold on long enough.
Within that timescale, OTAT will clear the pathway for income generating SRGvHD and Ards provided you have confidence in the science within current cash constraints. If you don’t believe in the science then why are you invested?
So maybe I cannot hope for a Mesoblast happy Christmas or New Year, I do believe I will see a great Mesoblast 2022 which will be dwarfed in the following years of exponential share price growth.
Regards
Yelrom
(20min delay)