From the May 6 CC: The manufacturing run for ou
Post# of 36568
(Total Views: 293)
Posted On: 06/06/2021 8:08:07 PM
From the May 6 CC:
The manufacturing run for our clinical supply will be filled on May 18th at the
University of Iowa Pharmaceuticals, great specialty fill-finish provider, and
they've done a great job for us too; and so, May 18th, we'll be filling our
clinical supply. From there, we have to just wait for the stability, stability, and
variants tests; it takes six to eight weeks--and this is what Joe has alluded to
before with the FDA. We have to have a full CMC package to go to the FDA
before we finally move for a Phase 1 IND.
...so, we should be 3-5 weeks from filing for the IND if I understand Rich Purcell correctly.
The manufacturing run for our clinical supply will be filled on May 18th at the
University of Iowa Pharmaceuticals, great specialty fill-finish provider, and
they've done a great job for us too; and so, May 18th, we'll be filling our
clinical supply. From there, we have to just wait for the stability, stability, and
variants tests; it takes six to eight weeks--and this is what Joe has alluded to
before with the FDA. We have to have a full CMC package to go to the FDA
before we finally move for a Phase 1 IND.
...so, we should be 3-5 weeks from filing for the IND if I understand Rich Purcell correctly.
(3)
(0)