I understand and accept all that, and you have been on a hot streak of late. Maybe my opinion of the FDA has been tarnished somewhat by MSB's experience in getting Ryoncil over the line, 3rd times a charm so they say.
My main reasons for thinking we are going to a Phase 3 trial is simple. Firstly, only 77 patients were in the Phase 2 trial, 8 withdrew due to adverse events (unrelated to ATH434) leaving 69. 19 for placebo, 21 for 50mg, 21 for 75mg, totalling 61. So where are the remaining 8 patients. 61 patients reported on + 8 patients withdrawing + another 8 missing (4 placebo and 4 75g dose) = 77. 77 is a low number to be giving accelerated approval for, even if they had all completed the trial. And the Phase 2 results were excellent, replicate it with a 200+ strong Phase 3 trial and we are in business.
ATH Price at posting:
1.2¢ Sentiment: Hold Disclosure: Held
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