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tredenwater2

05/09/23 12:28 PM

#414597 RE: Hoskuld #414544

quickly. A P4 is what makes sense when there is a huge unmet need and strong evidence that a relatively inexpensive approach (compared to IV infusions of mAbs) works better than all existing therapies.



Hoskuld, with ph 2 PDD data correlating 70% to AD it would be over the top to get some sort of Accelerated movement on PDD. The reason I mention this is there is a Ph 3 planned and a “confirmatory” AD trial may work the other way as well.

While we are waiting may as well ponder these delays. Quite the promising pipeline, looking more and more like they are “ backing into”one massive umbrella trial. Who would know how to do this more than the veteran VP of regulatory affairs. Mountains of paper pushed to date, mountains!