In defense of GNBT, they didn't promise anything b
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Posted On: 06/29/2021 6:10:34 PM
In defense of GNBT, they didn't promise anything by July 1.
They said that the manufacturing run for our clinical supply will be filled on May 18th. From there, we have to just wait for the 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.
6 to 8 eight weeks from May 18th is sometime between today and July 13. Today was the earliest to expect anything.
Purcell said July 1 was a date on his "internal timeline." But his quote above contradicts that.
They said that the manufacturing run for our clinical supply will be filled on May 18th. From there, we have to just wait for the 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.
6 to 8 eight weeks from May 18th is sometime between today and July 13. Today was the earliest to expect anything.
Purcell said July 1 was a date on his "internal timeline." But his quote above contradicts that.
Quote:
We are still waiting on an IND that was basically 'promised' before July 1st.
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