NorthWest Biotherapeutics Inc (NWBO)

[exwannabe]

MHRA timeline

So we are at least 14 months past clock start. MHRA says they have no reviews where they have been on clock for over 7 months. That creates only 3 possibilities.

1) MHRA is flat out lying
2) NWBO has been on clock for 7+ months
3) NWBO received the CHM notice that means major issues exist and NWBO must hash out with them

Several posters suggest #1, but this is really tin-foil hat stuff.

#2 is possible. But does suggest not all is smooth as 7 months of NWBO clock time does indicate that this was not as clean as most all longs thought it would be.

Many argue that #3 is not possible as NWBO would have to tell us. Not true. The CHM letter is not a final action by the MHRA, that would come later. And NWBO says no updates until a final action (and Court decisions agree that interim RA actions are not mandatory disclosures).

So how does this play out going forwards?

In the old guidence clock off was limited to 6 months. But as I said long ago, that is just guidance. In the new guidance it is up to 6M for RFI1 and 3 for RFI2. Technically the new guidance does not apply, but the MHRA drew it up for a reason. And they are not bound by it. So likely they were seeing this as possible.

In short, 7 months does not look totally whacko for RFI time, but is getting long.

OTOH, A CHM action would have 6 months for RFI1 plus 6 months for the CHM action.

And last, the MHRA can always make exceptions and extend.

Last , the arguments the delay is any of:
. EDEN
. SOC
. PolyICLC
. Tissue agnostic

None of these are in play.