Replies to post #667353 on NorthWest Biotherapeutics Inc (NWBO)

[dennisdave]

ooh come one the MHRA is saying marketing authorisation and reach its opinion on approvability within 150 days of submission of a valid application. The UK government website is saying it.
Many other reliable sources are saying it. Case closed seriously

[exwannabe]

Re: MHRA Day 0

Does not really matter because of the slot system, If the submission on the 22'nd was valid then the first assessment is completed at the Mar 21/22 CHM meeting. Does not matter exactly when it was validated.

But if they have to fix something then the completed submission would be after the cutoff, and the CHM meeting slips a month.

The time from cutoff to meeting is actually about 87 days. Whether one wants to charge the extra 7 days to validation or scheduling of possible snow hardly matter.

The key is the 3/21 CHM meeting (assuming the MAA was valid as submitted (which is likely IMO),. That complete phase 1.

To be clear, does not matter if the validation is late. All that matters is when the final valid MAA is submitted with respect to 12/25 cuttoff.