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Re: Watsonturtle post# 9653

Tuesday, 12/03/2019 7:24:34 AM

Tuesday, December 03, 2019 7:24:34 AM

Post# of 17456
This is great news and it is another reason why I was urging long term holders to look beyond P3 results so they can cash in the long term benefits of VCS, one of them being the absence of any adverse clinical impact on glucose parameters ( contrary to Tacrolimus).

As mentioned in the PR, this study ( benefit ) will be added to the NDA filing in mid 2020.

Also on a side note Watson, even AURORA 2 will take a couple of years to finish, we are expected to have results on early patient enrolments ( we are expecting something between 50 to 80 patients to have completed AURORA 2 by the time they announce P3 results ), and even though it is NOT a requirement for the FDA approval next year, the FDA has requested Safety data from AURORA 2 ( you can see how much FDA is focused on Safety after the 11% death rate that hopefully will be cleared out with P3)
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