Dog. I agree for the most part with the lack of transparency however, when you have the winning card in hand the control is outstanding. I believe Bavi is the winning hand. What's gone is obviously too late to recapture.
Garnick is a consultant and for that I feel good about having him on board.
Idog et al..doesn't the "shelving" have to do with patent start dates? ie..if they received commercialization for one indication, the patent clock starts ticking with only one indication approved, whereas PPHM is lining up several indications to be approved in rapid fire succession...imho Thanks in advance for any input.
That is not correct. They did 3 signal seeking trials at roughly the same time in 1st line lung, 2nd line lung, and BC entirely overseas to save money and find out what they had the best shot at moving forward. My guess is none of the trials (no control arms) would have qualified for ph III. They chose to do their one gold standard double blind study in 2nd line which Garnick felt was their best shot to get approved the fastest because of the unmet need and limited competition. Resources were limited and IMO they went for the double blind in 2nd line for the outside shot at AA
IMO they had a good strategy and still may be in position for BTD in BC which might just get them a phIII and would give them multiple phIII. There are many things to be unhappy with this team but the strategy they used to move Bavi forward is not one of them. IMO they were in position to pull a miracle out and the errors put a crimp in that. I think prior to the"sabotage" they were looking at AA for 2nd line and a possible BTD for breast. Now we will be delayed.
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