Replies to post #43000 on Biotech Values

[donotknowityet]

SPA from the FDA.

The quote and the referred document seems to be nonbinding guidelines, and not a law.

But it is indeed ambigouos.

So what is the law?

[AlpineBV_Miller]

The sentence is ambiguous, so we called. Here's what we were told:

Two clauses:

(1) Special protocol assessment will not be provided after a study has begun.

and

(2) Protocols for studies that have already begun can be evaluated by CDER and CBER, but they do not qualify for the 45-day time frame described in the PDUFA goals.


#1 means exactly what it says, end of story.
#2 means the FDA will look at your protocol and comment on it. It is not meant to imply you can get an SPA. It is the regular "comments are be provided" communication anyone gets in their post-Phase II meetings (just not on the 45-day clock mandated by PDUFA).

So, they are not contradictory after all. Hope that's clear.