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Saturday, February 06, 2016 11:17:25 AM
Pure speculation. You have no idea why they re-sized the trial and you have only a few clues as to the enrollment ramp. I also have a speculative answer...they re-sized it to buy time to ramp up for pending approval. The statement that 300+ were enrolled in the last two years is idiotic, since they reached the 66 event trigger back in December of 2013...I'm quite certain that 66 did not consist of the entire trial population...and the information arm could not have enrolled >50 without enrolling a good number of others into the trial.
They went straight to the P3 for a reason...
BTW, if the premise that the pseudos are causing problems with the trial were true, then that would have shown up in the DMC review and they would likely have ended the trial due to safety concerns.
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