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Re: Could changes at the FDA change everything Gary, It is not possible to submit the CMC section of the BLA, which is the mfg section, in two parts and it is not necessary to do so. Assuming positive data from the P3, they will submit it all in 1 BLA CMC section, and, given the time they have had to prepare the submission, it should be comprehensively prepared. If the UK submission is the first I would also expect some hand holding by the MHRA in support, given the status this product has been granted in the UK. |
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