Don’t get me wrong, there is always chance. However it is common practice to hire ex-FDA staff to reply to a CRL...it it would be negligent if they chose not to. So don’t think they are in any better position than anybody else.
The common failing is that each FDA staff member is a human being and have individual thoughts, expectations and experience.
Whilst there will always be room to navigate grey areas, and these ex-FDA consultants will always tell you there is a chance as they are paid to say this... how realistic that chance is they will never be able to tell until they meet with the FDA.
Don’t get me wrong, there is always chance. However it is common...
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