MSB to dispute FDA finding in Type A meeting, page-210

No it is not stated on the CRL. The FDA make that determination when they receive the resubmission of whatever they requested in the CRL.

I think what you are missing is that accelerated approval is a totally different process. It’s effectively a new submission asking the FDA to approve through another expedited process, rather than full approval.

While the bar is lower for accelerated approval, there are a lot of unknowns as MsB are proposing to change the primary endpoint to survival... rather than use the generally accepted 28 day ORR.

I think MSB are aware there is a very low chance for full approval coming from the Type A meeting later this month ... it’s like going to your exam marker and trying to argue why you didn’t get full marks for a question you thought you answered right. How likely is that exam marker going to say “yes sorry I’m wrong and you are right, here you go full marks”.

There is a lot of comparisons with other single arm trials getting approval, but what is different here is that there were two failed RCTs a decade ago saying it doesn’t work any better than standard of care.

Two failed RCTs vs one successful single arm trial.

If there was only one single arm trial to consider, then I think the FDA would approve. But those two failed RCTs were too compelling to ignore.

this is despite MSB providing evidence of the improvements in potency, which the FDA did not believe was convincing enough as there was no evidence of this in the pivotal clinical trial data.

like I said before, the FDA has set the bar very high and has not shown any leniency. That was my greatest fear, but also understand they are within their right to do that.

My guess is that at this Type A meeting, MSB may seek guidance on how to go down the path of accelerated approval. They are unlikely to get it straight away. There will need to be a review by the FDA of that accelerated approval submission as a new application and that will take time.