Next week I would love to see Monotherapy CROI pre
Post# of 148190
They said the 1st part of the BLA is ready to go. They listed the rolling BLA starting in February on a presentation this month, which ends today. NP said on Monday, they will fill for the pivotal trial after that first submission from combo. If there was ever a perfect time to announce it, it would be next week. They would be the talk of the conference I feel.
Of course this assumes the meeting with the FDA about mono, didn't have some more conditions we are not aware, like a little more data with the 700mg group first.
Quote:
14:30 submission quickly as possible in
14:33 regards to mono therapy trial we are to
14:36 present at CROI on march 4th our
14:39 abstract was accepted and we are excited
14:41 to go back to croy and say that our last
14:45 trial that we presented at CROI that had
14:48 only 40% responders rate now is change
14:54 and there with a seven hundred milligram
14:56 we have much better data and 525
14:59 milligram
15:00 so that we will follow through but we
15:03 are working on our pivotal trial and
15:05 once we submit our first part of our BLA
15:07 which is already complete
15:09 one third of a non-clinical section then
15:12 we will follow with our protocol for a
15:15 mono therapy pivotal trial