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.
DEP always first, page-12
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