CEO Itescu needs to go, page-627

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16/08/23

10:55

Post #: 69365733
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Originally posted by dolcevita: ↑

These are good points:

IF the FDA had a deep-seated problem with CMC issues, which they did express during the ODAC hearing, why did they empanel a committee of experts to vote on efficacy in the first place??

The potency assay issue should have been picked up in the rolling submission or addressed before going to the trouble of an ODAC hearing.

In essence, FDA said, "We're not sure the product can be made in a uniformly potent fashion... but please give us a vote on efficacy of a product we can't be sure is made with uniform potency. That's nonsensical. Most likely answer is bureaucratic inefficiency (as opposed to corruption).

These are illustrating the statements I'm making about inconsistency and capriciousness of the FDA.

So SI and team have come back to them on assays and consistency in the expectation that is the remaining barriers to approval and they raise more issues and decide that they won't require double blind study on children but they will on adults.

What is the reasoning? This goes to policy, that must underpin the decisions and the criteria for making those decisions.
More importantly, why did they ignore the 9-1 vote on efficacy in children, and why did they not revert to this recommendation on efficacy once those additional manufacturing and assay requirements were met?

I also agree where there is confusion there is often incompetence and this should be suspected first, but you cannot exclude corruption entirely. If people speculate about corruption it is a valid matter to consider especially if there is an apparent conflict of interest in the dissenting vote of the ODAC. It's not as if the FDA is entirely consistent, ethical and transparent in all actions is it? So I think some healthy scepticism is in order.

it's difficult to avoid the conclusion that the FDA is casting around and requiring levels of scrutiny it did not previously require and also would not require of pharmaceutical drugs because they have an established model. The latter is not necessarily more efficient or more valid.

They are messing around with MSB and it's sensible to fully explore this before jumping to conclusions that supposedly, 'SI needs to go'.

This is what I meant by damaging emotional reactions. And that damage has been done. The thread needs to die but it won't because the originators want to feed it and we have to respond to that. So it's constantly putting out spot fires and trying to shift the focus not easy when so many fires have been lit.

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Why are we still debating the 9 to 1 decision. It is done and dusted let us move on. Such things may happen again. Is there anything we can do should it happen again. If so let us discuss

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