NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

They don't have access to the blinded data but they can request an FDA review when specific eventing targets are reached or not reached . . . agreed?

No.

They can ask the FDA whatever they want. I can ask the FDA for a pink pony.

But the IAs do not involve the FDA and SHOULD not provide information to the sponsor other than the halt/continue recommendation.

The FDA is responsible for:

A) Insuring that the IND is safe and in the public interest.

B) Approving a submitted BLA.

The FDA does not babysit trials. They do not decide if a sponsor should halt a trial early for futility or efficacy (though they can be asked for advice on the latter)