NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Out of curiosity, does the company get any notice whatsoever of an upcoming decision by the regulator.

Many years ago in the case of the FDA turning down IMCL's Erbitux, we know that the company had to release the news a day later, but the CEO and Martha Stewart sold the day before, so clearly some notice was given. They both got jail time for insider trading, and the drug was eventually approved, so they were the biggest losers in the deal, but clearly it indicates the company did get some notice. I don't know if it's still the case, or if the UK operates the same way the FDA did.

It's my belief that nearly all early decisions are positive, in the case of IMCL I believe they were at the PDUFA date and they pulled off the equivalence of the Sting in biotech's by convincing BMY to partner because they were certain the FDA approved when they knew all along that the FDA had questions that could result in further trials. Ever since them the FDA is authorized to indicate if their position is being improperly represented, before that time IMCL knew the FDA couldn't speak up when misrepresented.

Gary