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We dose escalated in P3, no reason we couldn't have done it in P2 to ensure that our P3 was correct from the get go.

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I don't know honestly how they would have in the mono p2. The other company ran a couple p2 trials, so they were not coming off straight p1. This mono is a p2b/3 trial, so my thoughts they are doing it where it would be done. The only issue is the combo trial needed safety data from mono messed up the design, they enrolled 150 at 350mg to satisfy the combo requirement. If not for that, I suspect they would have escalated much earlier, not 150 patients in.

For the mdr3 to mdr2, they requested and the fda denied that request. They also requested BTD and the FDA denied that request. From 2017 10k

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We applied with the FDA for breakthrough therapy designation for PRO 140, for certain HIV-related treatments. The FDA, in its comments to us, stated that we had insufficient data related to the population for which we were requesting such designation and we currently plan to submit additional data to the FDA as it becomes available to us from our Phase 2b/3 combination pivotal trial.

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Stability data, yeah, I agree with you there. But it looks like they are not going to get an answer to file part 2 before that data is done anyway. So it could have added some delay (3 months), with the slow FDA on part 2, looks like it would not have mattered.