Gary, if the MHRA includes every day in its count, that makes it worse. 3/15/2024 thru today comes to 469 days, over 3 times the 150-day goal. I agree that far more is likely happening here than a simple MAA submission of a new drug. Suppose I shouldn't say simple given a reported 1.7-million-page submission. That's a little over 5,200 pages per trial participant.
If the original MAA was more than an L submission, shareholders should be told. Just what was in it, nothing more. The MHRA can't complain about what was submitted - that doesn't violate any of their rules, just information that should have been made public prior to them. Similarly, if there are things like EDEN, tumor agnostic label added after the fact, those should have been made public - as long as they don't involve the MHRA internal processes.
Regardless, it's time for Powers or Goodman to get off their keisters and say something to shareholders that isn't buried in a required SEC filing to help support share price.
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