Flipper said he spoke with DI, which I believe he did, and Flipper said that DI said that the PIP trial redesign will (or should) have no delay implications on the MHRA decision. I however do not trust that DI knows much about MHRA regulation. Heck, it would not surprise me that when NWBO decided to modify the PIP trial design they were unaware of what the implications on the present MAA decision timeline COULD BE once resubmitted.
Cancelling ASCO was the signal.
That is where you and I disagree. This signaling is nonsense because it really is not in the hands of NWBO. I mean NWBO can do dumb things such as submitting a PIP redesign to the MHRA in the middle of the MHRA's decision timeline risking an MHRA pause or other stupid things to slow the decision timeline down, but NWBO does NOT know when the decision is made and therefore the suggestion of signaling is silly.
The ASCO agenda is out prior to the conference. They probably wanted to avoid having the shorts run with the narrative that no ASCO meant the application was denied. I never thought a decision would take this long but it is what it is.
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