CFH, the BLA was in progress BEFORE two annual meetings ago because not on the last, but the one before, Dr. Garnick was present personally and did a (long) presentation on the complete approval cycle.
I don't remember (because this is MORE then 1 year ago now) if he said it in his presentation or afterwards during the mingling but PPHM had already 500.000 pages of BLA written and electronically stored. The 500K is NOT a TYPO!!!
And what is more, since the FDA gave PPHM a Fast Track for SUNRISE they can send parts of the BLA to the FDA in order to have it already revised so that after unblinding SUNRISE they only need to prepare the work of the last unblinded data.
How long that will take depends on the contract PPHM signed for final unblinding. It is a 3rd party that unblinds. It may be that PPHM asked already for a lot of processing work to be done as data comes in. Not sure if in this case the CRO also unblinds (it wasn't the case for the PII).
That is why PPHM could move to the FDA in 1 month as well as in 3 or exwannabe's 6 months. But PPHM has clearly been working around close deadlines and speed (within budget) has seem to be an important point in that. So they could have asked for a lot of pre-processing DURING the trial by the unblinding party or the CRO in order to reduce the work that needs to be done at unblinding when they will get that data. Not sure how this will work with SUNRISE.
And with Garnick PPHM has PLENTY of experience with BLA's, if not one of the MOST experienced players in the field with 17 trials passed including Avastin. He has several technical writers and is in charge of the BLA (as said on the annual). Those that claim Garnick is not involved, not writing it, etc are misinforming the board. Of course if writing means 'typing' then OK Garnick has a team that will type and write what he says and in that sense he may not be 'writing' it. But he reads and corrects what several others write on his demand, which speeds up things.
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