Replies to post #423726 on 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.

[skitahoe]

I agree with most of what you're saying, but not that they would tell us what they're doing with the regulators. This is far from just NWBO who don't discuss what they're doing with the regulators. In that the FDA, and I believe most others, won't discuss what others are doing with them, unless their position is misstated. If the company says nothing, the regulator says nothing.

I believe the so called rolling BLA is not just possible with one or more of the regulators, I think it's probable. I believe we're working in at least one of the programs intended for expedited approval. I frankly cannot say just how expedited such approvals are. Normally the FDA takes 6 months evaluating a BLA on a product intended for a potentially terminal disease. If a rolling BLA were submitted, say in 10 parts, and each part were independently reviewed and approved, perhaps approval could come a matter of weeks, or a month or so after the 10th part was submitted. I don't know if the FDA would even set up a PDUFA date 6 months after they received the complete BLA if they intended to act far quicker than that.

I don't know of approvals coming before it was acknowledged that a BLA or NDA was submitted, though I believe in a few cases the DSMB's have gone to the FDA and it was determined a trial should be ended early and a drug approved. I was on one such drug, Gleevec. I continue on what's considered to be it's third generation, Sprycel.

If in fact we're doing a rolling BLA, I don't know that we're not a matter of months till we have at least one approval, and if the regulators are acting in unison, we may gain approvals by all of them simultaneously. I'm not saying this is the case, only that their are programs that we may be operating under that could make it happen. I believe that TLD and Journal will proceed this, but no telling by how much.

Gary