(Total Views: 573)
Posted On: 05/20/2020 5:43:03 PM
Post# of 153864
“- FDA Ruling mTNBC (1-6 Months)
- FDA Ruling Combo HIV (1-6 Months)”
This timeline strikes me as impossibly optimistic. I may be wrong, but my understanding is that in the absence of accelerated approval (which we do not yet have for combo HIV), it could take up to 8 months for a ruling. It is impossible for me to believe we would be approved as early as a month from now: “4-8 months” is far more plausible. Likewise with mTNBC—I would be happy just to get a BTD meeting with the FDA in the next month. NP was talking about 30 days just to get the next 10 patients injected. I don’t expect any sort of decision on cancer from the FDA before September at the earliest.
- FDA Ruling Combo HIV (1-6 Months)”
This timeline strikes me as impossibly optimistic. I may be wrong, but my understanding is that in the absence of accelerated approval (which we do not yet have for combo HIV), it could take up to 8 months for a ruling. It is impossible for me to believe we would be approved as early as a month from now: “4-8 months” is far more plausible. Likewise with mTNBC—I would be happy just to get a BTD meeting with the FDA in the next month. NP was talking about 30 days just to get the next 10 patients injected. I don’t expect any sort of decision on cancer from the FDA before September at the earliest.
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