How could MAA be rejected? This is no such possibility.
There is certainly a possibility and you are an uneducated, ignorant fool if this is your actual stance. Not even worth discussion. Nothing is certain.
How could MAA be rejected? This is no such possibility.
. The P3 trial randomized 233 to -L and 99 to placebo. The trial's designed primary endpoint failed badly and the OS secondary almost certainly did. . After an efficacy IA that informed them that the trial was sucking they changed plans. . They waited for OS between the arms to save the trial, but that failed. . The change to ECA was post hoc as they already knew key information about endpoints even though the trial was still blinded. . The ECA was not designed prior to commencing the trial as the FDA says in their guidance. . The ECA does not have patient level data as the FDA calls for in regulations , The bias introduced by extent of resection is a serious issue and they have no data to adjust for this. . CMC can be challenging as the trial spanned decades and the proposed facility was not used in the trial. GMP is not sufficient, one must have equivalent process.
There others. I thought the O'Brien Flemming adjustment for the IA when the FA was a completely different dataset was comical. And who knows how much is unknown.
Anybody who thinks there is little to no risk is seriously delusional.
Not a chance of over 1000 compassionate use. Not a chance 100 compassionate use. Probably 10.
The MHRA will piggyback FDA decisions, not the other way around. And the company hasn't secretly submitted a BLA so "readiness" whatever that means is just another ridiculous bunch of crap.
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