This was in NP’s email which I fully believe. M
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Posted On: 11/03/2019 7:57:38 PM
This was in NP’s email which I fully believe. Maybe we will get to see these emails, but it isn’t hard to see without them and the phase 2 trial with 350mg nowhere near 70%, and the phase 1 safety data stopping at 350mg, wrong half-life, lots of obstacles to overcome.
Yes, they could have went Combo, but the FDA said in October 2017 they wanted another 50 patients on Combo. At 2-3 patients enrollment per month, that would have taken 2 years to enroll, they might be finishing up enrollment now, with 25 weeks more for data. So, no the FDA wasn’t going to let them do as IZ, even without mono. NP talked the FDA into using the mono trial data for safety.
Yes, they could have went Combo, but the FDA said in October 2017 they wanted another 50 patients on Combo. At 2-3 patients enrollment per month, that would have taken 2 years to enroll, they might be finishing up enrollment now, with 25 weeks more for data. So, no the FDA wasn’t going to let them do as IZ, even without mono. NP talked the FDA into using the mono trial data for safety.
Quote:
Success with Monotherapy that took me changing our KOLs mind several times from stopping the mono and realizing that there is a path to approval and the FDA so far has agreed. All these are recorded with emails and so forth and in future (maybe) everyone will be able to see those emails.
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