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manibiotech

01/15/25 12:19 PM

#743833 RE: flipper44 #743832

Hopefully so 
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exwannabe

01/15/25 1:19 PM

#743844 RE: flipper44 #743832

A few long in tooth longs have been chanting remember this might take a little bit longer due to two indications being reviewed.


FWIW, Casgevy also had 2 indications and was approved in what was record time for the MHRA.

Agree with you wrt the 1.7M pages. There is a lot of extra supportive data on the CMC side as they had something like 1000 batches manufactured and each requires the full documentation that a single batch of 100K doses of a CI would. The MHRA will not go through all those pages slowly line by line. Several will be verified in depth, the rest they will spot check to see that they match. That is IMO, but is fairly obvious.
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Steady_T

01/16/25 1:09 AM

#743927 RE: flipper44 #743832

What source do you have for this conclusion?

1.7 million pages is just not exceptional for MHRA reviews.