Replies to post #338830 on NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

Nonsense. Actually it's hard to believe NWBO after 14-years of DCVax-L PIII trial and numerous major rounds of communications with FDA has not been in a rolling BLA submission to FDA.

Pathetic pumping.

To start, they do not even have Fast Track or any other designation that is required.

Beyond that, It is far more complex than the SAP that was a "ganormous" task for them. The resources needed would be far more than they have. It would show in the financials.

Few small dev stage bios initiate rolling submissions, And for good reason, spending the cash prior to positive results would be foolish.

[skitahoe]

Dan,

I believe that when Les said that was months ago when TLD was anticipated by early July, it's a very different scenario with TLD not yet issued in mid December. As I understand it, an awful lot of material goes into a BLA, I'm no expert, but from what others have said, I have a feeling that most of the paperwork developed by our contractors when the trial was locked will be in the BLD. If that's the case, I think you could make the claim that the BLD is in development, but it's a long way from being completed.

I would think that we'd have done very well if we have the BLD submitted to the regulators by the second quarter of next year, which makes approval possible by end of the year. On the other hand it's been said that some regulators may be willing to look at the data and permit DCVax-L to be brought to the market, I don't know that this would be considered an approval, or essentially a EUA similar to what's been done with the Covid-19 vaccines.

Frankly I believe the regulators should use the EUA far more frequently when positive results are revealed for products that benefit people with terminal diseases. That would allow the drug maker to immediately earn money from the product, in the time that full approval was being sought after, the funds being generated would permit the company to run other trials to potentially expand the label. The EUA should have some time limit so the company couldn't ignore putting together the package for submission, but given the delays often caused by the regulators, 2 or 3 years to approval would not be unreasonable. IMHO, every product authorized by an EUA should have every application accounted for in a Phase 4 Trial, essentially just tracking all use, including off label, for the product. Information gained in the Phase 4 could potentially be used to achieve label expansion for the product.

Gary