Replies to post #528549 on NorthWest Biotherapeutics Inc (NWBO)

[dr_lowenstein]

that is not only wrong it is ridiculous

[dr_lowenstein]

but apparently not the journal peer reviewers LOL LOL:

[HyGro]

PFS was thrown out after the clinical trial was completed and all the data was gathered. No biotech gets to select their primary endpoint after all the data has been gathered. The original protocol had PFS as the primary endpoint and FDA approved it.

NWBO will take months to prepare an application for commercial approval for the FDA. FDA takes two months to review the application for completeness and either accept it or provide a RTF. If accepted they provide a PDUFA date that has standard timing of 10 months. That will put NWBO into 2024 for any potential approval.

Testimonials don't count for any approvals. It works for dietary supplements that don't do clinical trials, but have no benefit for prescription drugs.