NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

The Project Orbis process is apparently expected to be kept confidential. It seems to be on invitation basis from the FDA. I can't speak to either supposition, but I don't think I can eliminate EITHER possibility, and I am starting to believe, given other indirect indicators, that something is up in terms of the regulatory process that is not the previous, heretofore same-same thing that we're used to seeing with the FDA. The FDA is rolling out a lot of new programs, left and right, that seem to be substantially different than what we saw in the past. At least that is my impression. And of course, it's just my opinion, I'm not an expert, it's not advice, and I am just a keen observer as I watch my various investments.

I would have agreed with you not that long ago, but probably have just been quiet. Right now, I am not sure, but there are indicators that suggest to me that there is something likely going on that is probably a bit different than the standard old wheelhouse doing its thing at FDA.

This is ALL PURE SPECULATION, but so is investing in these early companies in general:

I do think, at the end, we will see things that look the same, but do they have an RMAT application in process or quietly approved and not revealed yet? I have no idea, but it's possible given my survey of the RMAT approvals and rejections this year, that I offered last night. Or is it possible they have some other accelerated status? Well, they used to have that in their disclosure documents that they were intending to apply for such status, and it is no longer there. Did they apply? I think it seems likely. Would it have been rejected? Honestly, given the circumstances I see from just their 2017 published paper, the seriousness of GBM, it's evolving definition and the paucity of treatment options for the newly defined condition, and their intense focus on getting manufacturing certified and having an impressive scale up plan with Flaskworks and multiple potential contract manufacturers in the hopper, as indicated also in their most recent 10-K, I think they'd likely be well positioned for approval of any of those accelerated status options, but especially the RMAT option.

And if all of that was done in consultation with the FDA to be positioned for an invitation into the Project Orbis process, which is confidential, then yeah, I don't think you'd hear a word from them. I think they would be quiet as an ice cold, clear, windless night in the arctic. Which is where we find ourselves.

ALL IMHO.