NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I agree with your thinking in general, but I also believe the lead clinician has a great deal of influence. I also believe that the FDA and other authorities won't put a stamp of approval on the SAP, but they will discuss it with the company, do you think they'd be wise to submit it after one of those authorities suggested a change.

I do believe the day will come when after incorporating suggested changes they won't sit down for more, and the SAP will be submitted, but I don't know that they're that frustrated yet. On more than one occasion I've seen the FDA ask for something additional after a BLA or NDA was submitted after their full six month review period. What they asked for sometimes could be provided almost immediately, at other times it required an additional trial, regardless, it was answered. Six month later, after the FDA's review, they asked something that was totally unrelated to the first question. My point is, they can cause delays in drugs thought to be sure things, but occasionally they go the other way and approve something that most believe is marginal at best.

Someone knowing what the FDA was going to do could make a lot of money on either the long or short side, as long as they had reliable information.

Of course the FDA doesn't always take every last day of the time they're allowed to make a decision, but it's said they could take 6 months to decide how to hard boil eggs, as could Congress, so it's rare that anything happens quickly there.

Gary