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Posted On: 07/17/2023 3:28:51 PM
Post# of 145890
My impression is that we could take the data from all the trial sites and give it to a CRO (a better one than Amarex hopefully) and they could put together a BLA. I think the reasons why we don't do this are that we don't have the cash to pay a new CRO, we want the full impact to our business to be shown in the arbitration so the damages can be maximized and the market this approval was to be for is not a valuable as using any funds to go after other indications.
of course, i could be wrong and the protocol and the results just don't match enough no mater how you piece it together and a BLA can't be done.
I will also say, the combo HIV trial was not the most well thought out path. there were many difficulties in getting any protocol approved and the merging safety from other trials was always an optimistic way of doing things. this was never meant to be a combo drug, it was a mono drug always and the combo trial was because the FDA wanted it this way first.
of course, i could be wrong and the protocol and the results just don't match enough no mater how you piece it together and a BLA can't be done.
I will also say, the combo HIV trial was not the most well thought out path. there were many difficulties in getting any protocol approved and the merging safety from other trials was always an optimistic way of doing things. this was never meant to be a combo drug, it was a mono drug always and the combo trial was because the FDA wanted it this way first.
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