Replies to post #523523 on NorthWest Biotherapeutics Inc (NWBO)

[norisknorewards]

yeah, that makes a ton of sense, how f'ing ridiculous of a statement. SMFH

[supersteve13]

The PIP approval indicates they are in process of MHRA authorization application. You already know this.

[hoffmann6383]

Bullshit. You don't complete the PIP and then just decide, hey, lets just stop at the last step before filing a MAA (or BLA).

Nonsense.

Have a great one Ex! by.

[skitahoe]

I don't know how many times things need to be said, going back to when L.G. appeared on the show they've been saying that they're advancing toward approvals. Their actions clearly show that's where they're headed. Companies don't discuss their meetings with the regulators unless something official occurs. When they make a submission they don't announce it, if it's accepted, then they announce it. If the regulator doesn't accept it, they'll provide guidance on what needs to be changed, they make the change, resubmit, and wait to see if the get an acceptance. Again, they only announce the acceptance.

If the company were going round and round with one or more of the regulators for months, or even years, in getting something accepted investors would never be told. When whatever the issue was is accepted, then the company notifies investors. We'll never know if they've spent weeks, or months, or years in getting the item accepted by the regulator.

It's my belief that the SAP took far longer than the company expected to get the concurrence of all four regulators. I cannot say if they ever got all four to accept precisely the same document, or if their are variations in each of them. My point is, we'll never know, you all may have beliefs that are different from mine. All that's really important is that they got it done properly, I.E. the new SAP was accepted before the trial was locked and they were unblinded to the data.

When it comes to the FDA, when they accept an BLA or NDA they schedule a PDUFA date that's their target for a decision on approval. For IMGN, which I've indicated I'm invested in it was clear they intended to file for MIRV, if I remember correctly they estimated what quarter they intended to do it, but that was it until they announced their PDUFA date, as I remember it. If you're interested their date is November 28th, and I believe they could act early, perhaps by several weeks.

In the case of the FDA, their PDUFA date for deadly diseases is normally 6 months after they accept the application. In the case of the U.K. I understand they try to decide in 4 months or less, but I'm uncertain if they publish a date at all, I welcome that guidance from anyone that knows how the other regulators operate. Most companies announce their PDUFA dates, a calendar of these dates is maintained here:

https://www.fdatracker.com/fda-calendar/

This is not an FDA document, it contains what's been announced. If a company doesn't announce a date, it won't be found anywhere that I know of.

Gary