NorthWest Biotherapeutics Inc (NWBO)

[skitahoe]

Something I didn't state, but it should be understood, the reason companies don't PR when filing with regulators is that the regulators often don't accept the filing without modifications, they ask for changes and they get time to review the changes, so what begins as a 30 day review could take many months before full agreement has been reached.

Frankly, in the FDA process of approving a drug, they typically have 6 months and in some cases a year to review the NDA or BLA. After 6 months if they ask for something, when it's resubmitted they get another 6 months, and at that time they can bring up another issue that's totally unrelated with what they requested in the first place. In short, the FDA if it so chooses can hold up approvals for years on what often are really minor issues but they get 6 more months each time an issue is replied to. I'm not saying they always take the full six months, but they may and in the past I've seen them do so.

Companies don't speak about what they're doing in working with the regulators, the last thing they want to do is criticize those who are regulating them. We'll really never know just how frequently they're working with the regulators, we'll know when the regulators take an official action, whether it's an approval, or something requiring further action or denial.

Gary