Replies to post #514613 on NorthWest Biotherapeutics Inc (NWBO)

[Doc logic]

Hopeforthefuture3,

I defer to any well studied and validated opinion of legal experts in FDA guidance able to dig into the language perhaps better than the understanding that I have but I did dig pretty deep and I guarantee you the lawyers for big pharma and big hedge funds did too.
The BLA is a HUGE process but with 7 years to put it together it’s been possible to do it like eating an elephant.. one bite at a time. The only question since 2015 is how long it would take to get commercial scale manufacturing and ECA guidance in place. Well ECA guidance has been ready to put into place but hasn’t been written in stone yet and manufacturing is about to be approved so all that is really left is BLA approval. If parts of a BLA/MAA have been submitted over time and the only part remaining is manufacturing related then as flipper44 has opined, and I agree with him, the MIA and MAA can be approved pretty much simultaneously and FDA could do an approval Sub Rosa based on qualifying conditions but likely will not depending on how much pressure they are under and cover they can get from various entities to either lead or knuckle under. Best wishes.

[sentiment_stocks]

Just to make a little, but somewhat important point, the SAP is a separate document from the protocol. There were always protocols for the trial, and they were updated as the trial changed, but there was never an SAP until the version they recently completed was submitted.