Replies to post #206728 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Yes, it has a few times.

The RTOR program as of now is only for drugs that are already approved for other indications/settings. Even then it can not have manufacturing or formula changes.

There is reason why the FDA is restricting the program as of now. There is a lot that goes into an evaluation other than trial data. That takes time (that is the reason for the rolling review, to allow these other parts to be done while waiting ion the trial data). Also, an already approved drug can be used for the new indication anyway. So the FDA is just vetting a new label.

It would be nice to see the program evolve to where a sponsor can start a rolling review of the other data early, and then use a real-time review of the trial data. I hope the FDA sees it that way as it will save many months.

[NNBPEfan]

Lorie, thank you for this great post. The new FDA procedure should definitely speed up the L approval and ultimately Direct approval as well.