NorthWest Biotherapeutics Inc (NWBO)

[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