I have seen a few people asking why we are going t
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I have seen a few people asking why we are going to try LL with two other drugs and not go for a big stand alone trial .....3 reasons (1)we ain't made of dollar bills and (2) last time FDA said we were not significantly better than Keytruda therefore no "fast track" designation (3) we are butting heads (like rams) against Keytruda again. If we help Keytruda and/or other drug might find a partner easier, and faster approval. I think it is brilliant. Also. I am not Ohm20 and do not pretend to be ..... perhaps he should explain it better. I digress to Ohm20.
The FDA comparison was to Trodelvy not Keytruda. Trodelvy was the best mTNBC drug out there at the time. With Keytruda we would have put it to shame. Are overall results were hampered by the 350mg arm and the small patient population. We also got poleaxed by Amarex not giving us all the data. We knew we had a median overall survival of over 12 months (Trodelvy - 12.1 months) but Amarex wouldn't give us further data. We won't know what the true mOS is until the breast cancer conference.
The combination with Keytruda will add nothing. Trodelvy being chemotherapy would make a good combo.
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