According to Nader we could still get a BTD for mT
Post# of 154183
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Posted On: 02/19/2022 9:23:48 PM
Re: chazzledazzle #118721
According to Nader we could still get a BTD for mTNBC if we did another analysis that was substantially better than Trodelvy. Longer terms with our patients. We were only slightly better than Trodelvy in our phase 2.
I will add that Ohm stated the problem was our patient count of 28 could be part of the problem. I think Trodelvy/IMMU had a small patient amount similar to ours and received a BTD but they were being courted by Gilead probably before the BTD and the big boys club influence probably helped. Eventually being bought out by Gilead.
I think we should just get started on the Fast Tracked BLA application and not waste the time in a BTD that could be denied yet again. Why waste valuable time with our platform drug…
I will add that Ohm stated the problem was our patient count of 28 could be part of the problem. I think Trodelvy/IMMU had a small patient amount similar to ours and received a BTD but they were being courted by Gilead probably before the BTD and the big boys club influence probably helped. Eventually being bought out by Gilead.
I think we should just get started on the Fast Tracked BLA application and not waste the time in a BTD that could be denied yet again. Why waste valuable time with our platform drug…
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