Interesting, Very interesting!! I have a few quest
Post# of 148181
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Posted On: 07/14/2020 12:50:56 AM
Interesting, Very interesting!! I have a few questions and many be some of you can help me out here
1. Did NP say some S2C patients get 4 x 350 too? But I dont remember whether he said they are getting 4 doses or he is thinking giving them 4 doses. I worry FDA comes back and said give them 1400 data.
2. If the BLA is for combo then where is the combo part for 700mg? Can they assume the combo result with 700 is good based on the result of 700 only? Or will they come back after the 700 result and say "Great, 700 is safe, now do the combo with 700".
3. If 700 result turns out to be amazing, can Cydy just go for mono BLA instead of the combo? To me, result for 700 probably is amazingly good and that make the combo trial totally moot.
1. Did NP say some S2C patients get 4 x 350 too? But I dont remember whether he said they are getting 4 doses or he is thinking giving them 4 doses. I worry FDA comes back and said give them 1400 data.
2. If the BLA is for combo then where is the combo part for 700mg? Can they assume the combo result with 700 is good based on the result of 700 only? Or will they come back after the 700 result and say "Great, 700 is safe, now do the combo with 700".
3. If 700 result turns out to be amazing, can Cydy just go for mono BLA instead of the combo? To me, result for 700 probably is amazingly good and that make the combo trial totally moot.
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