Replies to post #416919 on NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Flipper, back many years ago after ENMD was clearly lying about how smoothly things were going with the FDA regarding the approval of Erbitux in order to gain a partnership with BMY, afterword's the FDA changed it's rules regarding speaking up if others lied about what they were saying. Your post clearly shows that they'll not disclose what others submit to them unless their position is errantly stated. What I mentioned above resulted in the CEO and Martha Stewart spending jail time for insider trading as they sold before the disclosure the FDA wanted additional trials before Erbitux would be approved. BMY profited nicely when Erbitux was approved years later, but no doubt wouldn't have paid as much as they did if ENMD hadn't lied about what the FDA was telling them.

While the FDA may not reveal a BLA or NDA filing, I'm uncertain if the PDUFA date once established doesn't become public, even if the filing hasn't been announced. I don't know how rapidly the PDUFA date is established after the filing of a BLA or NDA, but the priority that should be given to a life saving product, like our vaccine, ought to establish a PFUDA date that's 6 months after the filing.

I don't believe that most companies discuss most of the communications they have with the FDA or other regulators. Better to say nothing, but do what the regulators request, than telling anyone about discussions with the regulators, especially if there is any chance the regulator doesn't agree with every word that's said. I can't remember a company saying they're doing a rolling BLA, etc. They may be doing it, with the FDA's agreement, but they don't PR such events. As you pointed out, not quite 90% of BLA filings are somehow made public, thus slightly over 10% are not. My question would be, if a BLA or NDA is not made public, is the PDUFA that should be established for it become public, or is that hidden too until the company makes a disclosure. I suspect a PDUFA date should be disclosed at some point, but I'm uncertain how quickly after it's assigned, especially if the filer hasn't stated that they filed the BLA or NDA.

Gary

[foxhound02]

Flipper:

I have already read the summary of this paper. It addresses whether the "submission" of a NDA or BLA is made public. It does not provide data on whether the preparation of a BLA is made public.

What I would like to see is an example of a company who blinded the entire BLA preparation process from the public.