Replies to post #338838 on NorthWest Biotherapeutics Inc (NWBO)

[jimmy667]

That is what happened to Immunomedics cancer drug. They got accelerated approval for immediate use and were in confirmatory trials when they were bought out by Gilead for 21 Billion dollars.

[BWIS]

Stop making too much sense Gary.

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.