NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

I hope I'm wrong, but I doubt if they'll PR the SAP, data lock, etc. I believe the first thing we see will be the top line results. I base this on what I've seen from other companies, as well as their prior hesitancy to discuss items which they could have possibly issued PR's for.

I suspect that they're meeting with representatives from the regulators in developing the SAP, but it's not something the regulators sign off for as accepting. It's my belief that FDA staff may guide in one way, and one or more of the FDA G-d's, like Dr. Padzur, may not agree with the guidance provided by his staff. In that case, even if the trial met or exceeded what was in the SAP that FDA staffers agreed on, Dr. Padzur could still say, I have additional concerns or questions, and I want something more.

Please don't get me wrong, I still believe once we've seen the data we'll know the vaccine will be approved, what I feel you can never be certain of is delays the FDA may cause while in the approval process. I've seen many drugs I felt certain of approvals delayed by FDA actions, but in the end none were denied, no telling how many tens or hundreds of additional millions had to be spent, or how many patients failed to get what may have been life saving treatment, the FDA got it their way.

That said, I really hope that once top line data is out, serious discussions regarding a partnership, or perhaps a buyout, are entertained, and sometime before the FDA decision date such an agreement has been finalized. In my mind, this would assure success regardless of the actions of the FDA, but it would lessen the likelihood of delays as they'd both have the experience of the other company working for them, as well as a bias the FDA seems to have toward BP.

Gary