Ann: FDA Advisory Committee Sets Review Date for Remestemcel-L, page-475

Okay, for my own sanity, going to try to not look at this board the next few days, and will instead bathe in the relaxing waters of RatFink's new hangout.

But will just say this:

All (and particularly new buyers and new posters):

I have said it before, the FDA is going to be TOUGH but FAIR.

This is an ADVERSARIAL process. It is designed to push the manufacturer on ANY areas of weakness to ensure that all questions are answered or not. The ODAC notes were never going to say "Welcome to the club, MSB." It was ALWAYS going to list out the weak points and demand that MSB convince them those issues aren't fatal to its application.

MSB will need to show up to the meeting ready to effectively and convincingly argue in support of its application, as they have been doing with the FDA for YEARS now in relation to this product. Give them a bit of credit, you haven't even heard what they have had to say in response to the FDA's questions yet.

And micro issues of the AdComm process aside...does anyone think that the meeting is being done in isolation from or without cognisance of the macro issues, i.e., that the same product under review here is also currently undergoing a 300-person trial for what could be the first (and for who knows how long, ONLY) treatment for COVID ARDS?

Ask yourself: how realistic is it that the ODAC, and eventually, the FDA is going to nix Ryoncil for AGVHD approval on lack of proof of manufacturing quality and consistency...when (1) the product has been manufactured and used for YEARS now without a single safety incident or side effect; and (2) disqualifying Ryoncil on this basis would also doom Rem-L (the identical product) for approval in relation to COVID ARDS in the near term?

After this process is done, anyone looking at the ODAC briefing notes and the transcript of the AdComm after this will have no doubt that MSB got put through its paces. And so long as the answers provided by MSB are clear, thorough and convincing, if the ODAC recommends approval, and the FDA does approve, no one will be able to argue that MSB didn't rise to the challenge.

Again, this is an adversarial process. As a litigator, I am no looking even more forward to the AdComm to see how MSB vigorously defends its application.

And if you sold today because you don't have the guts to watch a company you are invested in fight with regulatory bodies for approval of its products, you may want to reconsider whether investing in biotech companies is really for you.

See you in a few days!