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clarity please on "second hold" - dr j says the FDA never did THAT before, and, most likely, he is correct. never did this before for any company or drug ever. ever.

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That sounds like a bit of skullduggery on the FDA's part. If a safety hold is lifted it's because the drug is proven safe in that indication. Since the previous trial and proposed trial are for HIV once that hold is lifted it shouldn't be reinstated for the same disease.

When the news about what type of trial was announced I had a fleeting thought. It's like the FDA is trying to force us into a trial where we wouldn't be competition to other drugs and the revenue would be much smaller. Approval would also start the clock ticking on the 12 year exclusivity. Which is why I'm damn glad we're also doing the glioblastoma trial.