Replies to post #292245 on NorthWest Biotherapeutics Inc (NWBO)

[hankmanhub]

So if we assume priority review of 6 months and a 6 months for the BLA (if all goes smoothly), then a PDUFA of about 1 year after TLD is a reasonable possibility?

[skitahoe]

I'll agree with you, with one possible consideration that could quicken it a bit, namely a BP partner that wants to push it. Even then, I would suspect the very best they could do would be 4 months, and it's unlikely. It's also very possible to take 9 months or more doing it, especially if they go it alone.

I believe a partnership will be the next major event after TLD is released, though the complete data might be presented at a technical conference first, which would also be important.

I believe that some people indicated that one, or more of the regulators might evaluate the trial on their own, suggesting that some sort of approval in some country might occur prior to BLA submission. I don't know if this is purely wishful thinking, or a real possibility. I do know that good drugs are often available elsewhere before they're available in the U.S. so I believe that anything is possible.

With what's happening with Covid-19, I believe it's clear that regulators may act without all the normal filings being made, in fact they can look at less than complete trial data and determine a drug can be used. I don't know that our vaccine can get that sort of priority anywhere, but anything is possible.

After results are released it may be possible the company could make it available under compassionate use, or right to try provisions, while awaiting approval. As I gather it, what they can be paid under such terms vary by country, and most companies are unwilling to do it in the U.S. as they won't give the Govt. all it wants before charging anything for the drug.

I believe in the idea of right to try, but don't believe it will be used as intended until a pricing formula is arrived at, not the company revealing information on production costs they're simply unwilling to supply. In general it takes well over a year after TLD is seen to gain drug approval when you allow 6 months or more for a BLA, then that much time or more for a decision by the regulators. Drugs that clearly are worthy of a BLS or NDA submission should be available at some reasonable price during this period.

Gary