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Hoskuld

10/03/25 11:34 AM

#502079 RE: boi568 #502075

It is very clear. And it is not about being in "my favor" (assuming you think this is some sort of contest, which it is not.)

A draft guidance or even a guidance document for AD therapeutic development does not need to be followed. A company is breaking no laws, nor, in the case of prodromal patient population, even going against the spirit of the guidance.

I don't understand why this is so hard for you. This is not cGMP guidance or Pharmacovigilance guidance.