MSB to dispute FDA finding in Type A meeting, page-405

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kervio

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05/10/20

16:20

Post #: 47860607
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Originally posted by stockrock: ↑

What I wanted to highlight is that the decision by the FDA was so shocking that we can't really rule anything out. It's easy to look at this in hindsight after the decision to issue the CRL on the grounds of efficacy and simply attribute it to the FDA's hard stance and strict adherence to the rule book for a novel treatment in MSCs.

But when there are specific requirements in the Federal Regulatory Code to show leniency when assessing efficacy and safety for treatments intended to treat life-threatening illnesses (CFR 314.125 (c)), and an ODAC vote of 9-1 in favour of efficacy... for the FDA to land on a decision that goes against both these two very strong mechanisms that are there to allow the FDA to tick off efficacy... then something is not quite right.

What really struck me wasn't the fact a CRL was issued... it was that a CRL was issued for efficacy. Because if this hard-line stance is an indication of what the FDA are willing to do going forward, then if they were to act consistently ... they'd throw the rule book at MSB at this Type A meeting and not allow MSB to circumvent the process by trying to go to market through accelerated approval by changing the primary endpoint from 28 ORR to survival.

In my view MSB really need someone willing to bat for them at this Type A meeting, someone at the FDA willing to go out of their way to agree to an accelerated approval request at such a late stage of the review process. The Sarepta example in late 2019 is a case in point, where a FDA director at the Type A meeting was on their side, and generated a lot of internal and public controversy by pushing it through accelerated approval.

What I want to point out as a point of unease, is that if we end up with another hard-line RCT supporter Director at the FDA overseeing this Type A meeting, then there is a chance we are told that the FDA is unwilling to approve the product unless we do an adult and/or children trial.

Like you said, we really don't know what the CRL contained in totality... and although SI and FG sounded sounded confident on the call, they went only as far as saying they were going to explore the potential pathway to accelerated approval and try to come to an agreement on that path at this type A meeting.

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Your posts in this thread should be required reading for HC holders. They've been thoughtful, well researched and considered, with a lot of good information. I hope I didn't come across as calling you out in my post, because I just jumped on a small part to discuss something I have seen a lot in the past few days.

Also, full props for this post in which you correctly called what was happening with the trading halt:
https://hotcopper.com.au/threads/ann-trading-halt.5660357/?post_id=47792615

I'm loving reading what you have to say about all this, and what the next steps might look like.

MSB Price at posting: $3.56 Sentiment: Hold Disclosure: Held
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