NorthWest Biotherapeutics Inc (NWBO)

[anders2211]

So her strategy is to delay FDA while waiting for Sawston so they can submit all 4 at the same time?

what the heck are you talking about. We have not seen topline data so what is there to delay. Perhaps you are not aware but before a BLA can be submitted to the FDA a biotech company in most cases (fast track excluded) discloses topline data. So what is there to delay, we have not seen TLD yet? Please quote me the official Northwest statement where they said they are waiting for Advent to be certified first and then can submit a BLA to the FDA?

Your fantasy has no limits. Northwest did say that they will release the topline in conjunction with a scientific journal. That is the only event we are waiting for and why a BLA has not been submitted to the FDA aka been delayed.

And she will not use CRL in EU and UK because of what?

Because as you were able to read from the article CRL is building up capacity in the EU. Why would CRL be building up capacity in the EU if, as you assert, everything can be handled from Memphis for their clients? Also, the EMA demands close by GMP and before Brexit within EMA territory. So why pax 2x, x3 to have GMP build that facility in the EU when this can be done with Advent with all benefits among others more costs efficient?

And delaying just to submit all 4 at once would be insane.

Again what the heck are you talking about? You fabricated this delay of approval with all 4RA for reasons of GMP, not me.
I said they need the GMP in each territory according to the rules of that specific RA territory to get approval I never said they will delay until all 4 GMP are ready before submitting requests to all 4 RA's together at the same time. That is your fabrication.