NorthWest Biotherapeutics Inc (NWBO)

[Astavakra]

longusa said:

- If the PhI data did not get AA, then the PhII's with a more efficacious and rapid treatment regimen would likely get there. Those same factors would also deliver results much more quickly than the PhI, with a possible BLA filing and AA in 2016.

I can't imagine FDA protracting the study given the present environment and early approvals of Keytruda, etc. Think of the flack they'd get.

And is there any group slower than FDA? CONGRESS, and this is what was proposed Tues:

On Tuesday, the powerful U.S. House Energy and Commerce Committee proposed an ambitious bipartisan proposal to reform major aspects of the FDA and the American drug and medical technology regulatory regimen. If it wins final passage and President Barack Obama's signature, it would become the most significant healthcare reform law in America since the Affordable Care Act.

The draft bill, presented under the 21st Century Cure initiative, would make far-reaching changes aimed at streamlining the approval of game-changing drugs, enhancing collaboration and communication between the biopharma industry and government agencies, extending exclusivity to antibiotics and other important therapeutic classes, and injecting patients' voices into the clinical development and approval process.

http://www.biopharmadive.com/news/4-things-you-need-to-know-about-the-sweeping-fda-reform-bill-congress-just/357481/