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Why Meso is pumping today?, page-60

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bedger

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02/02/21

10:44

Post #: 50632257
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Originally posted by dplane: ↑

Of course MSB was aware there was a risk of rejection. We all were (and anyone that didn't think it was possible was kidding themselves). In any post I put up prior to the CRL, I always said there was a 95% to 99% chance of approval, never that it was 100% chance, and that the FDA could ALWAYS ignore the ODAC. Again, they have the legal right to do so, and the ODAC's decision is ONLY advisory.

It's easy to sit around and second guess decisions made in the past, but the fact is, none of us actually sat in on those FDA meetings, and cannot judge whether MSB's decisions or the FDA's actions throughout the process were reasonable or not.

I think alot of us on this board are pushing back against too-easy second guessing, arguing that it was NOT necessarily unreasonable for SI and MSB to push forward with this application, and NOT necessarily unreasonable to conduct a single-arm trial, particularly based on the very important information obtained from those two earlier "failed" trials--combined with the fact that we are dealing with kids here, so RCT NOT gonna work, AND based on the FDA's guidance.

I, for one, am willing to give MSB the benefit of the doubt, and view the FDA as more likely playing shifty pool in this process because:

(1) the FDA was SO venomous in that ODAC packet, which was entirely out of character with earlier approvals as the application moved through the process;
(2) they ignored their own ODAC decision, a really unprecedented act;
(3) the FDA has lost SO MUCH credibility over the last year with Hydroxychloroquine, Remdesivir and other B.S. solutions touted by Trump;
(4) there was really NO downside to granting limited approval for under 12s on the condition MSB commits to the over-12s trial (where at-risk lives can be saved immediately and reimbursed by insurance) and
(5) I have a ton of respect for SI and MSB and their integrity and professionalism--FDA not so much.

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Bar point 5 could not agree more dplane.

I am a little more circumspect about MSB management, but absolutely, any decent objective independent review of the GvHD decision will likely see the decision over-turned and EUA granted with a confirmatory Adult RCT trial. Lets hope MSB gets a fair review. Hoping for a little more professionalism from the FDA going forward given the bad attention it got under the pandemic.

MSB Price at posting: $2.51 Sentiment: Buy Disclosure: Held
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