MSB to dispute FDA finding in Type A meeting, page-425

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05/10/20

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Post #: 47865284
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Originally posted by bedger: ↑

Kervio, an excellent post as ever and pause for thought for even the most optimistic on here. Given you excellent objective reasoning (that is hard to contest) I would be curious to your opinion on two things that come to mind for me from your post.

A: If ultimately the main reasoning for voting against MSB was conservative thinking and self-protection, why have we seen other decisions, many cited examples in this thread, where the FDA has over-ruled a conservative and disapproving ODAC decision to grant approval to other less rigourously tested treatments, even with suspected safety issues? Would you put it down to sheer inconsistency across decisions or some other reasoning? Why 'protect their asses' here when they exposed them on others?

B: Whilst ultimately the GvHD FDA RCT stance would indeed push MSB to wanting full and uncontestable results for ARDS trials, are they not simply by the Bayesian and independent assessment design, ransomed to the results as they fall? That is, by deisgn (per FDA and MSB) are not both MSB and the FDA subject to pushing REM-L for emergencey use by the decision of the DMCB which will be solely based on the stats?

I made the mistake of being so impressed by the presentations of MSB in the ODAC meeting (in answering the FDA's concerns) and looking at precedence in ODAC advisories, that I never thought FDA would not approve. But I am not well experienced in these matters. The MSB Board are. I am going to be unpopular, but given it appears the FDA could never demand a conditional trail under the BLA application and MSB knew the FDA would likely require an RCT (and indeed planned for one), was it perhaps an oversight for MSB to have gone down this route in the first place? Should they have not gone down the accelerated path in the first place?

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May I interject and answer the questions addressed to Kervio?

A. IMO because the historical decisions were about drugs, but this is about a biologic and the first of its type.

B. Yes. But if the DSMB finds overwhelming efficacy at an interim review, MSB can still decide to continue the treatment arm on the full 150 patients, and even switch the remaining placebo patients onto the treatment.

MSB Price at posting: $3.56 Sentiment: Hold Disclosure: Held
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MSB to dispute FDA finding in Type A meeting, page-425

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