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Posted On: 08/09/2021 1:30:59 PM
Post# of 36541
If I remember correctly from the transcript, Hy, that was Rich talking when July 1 was mentioned. So, for all we know, Joe did not concur with that "internal timeline", and it wasn't what Joe was shooting for.
So, as my back and forth with Rjs concluded yesterday, I'm not sure we can really know anything about the IND submission date... other than we don't know if/when it was done or will be done.
FWIW, from the info available, I am coming to a subjective conclusion that it was not submitted earlier than the week of July 26th, per my earlier posts. That was based on 8 weeks (6-8 per Joe) from the 5/18 production run (completed per Joe) to receive the stability data, followed by up to 2 weeks for data analysis and IND prep after the stability data was available.
So I am expecting that, if the wheels didn't fall off in some way, the IND approval/feedback WILL be received (and we WILL get news) by the end of August at the latest.
IMO, if that date comes and goes with no update, something has gone awry, even based on the long end of Joe's information to-date.
So, as my back and forth with Rjs concluded yesterday, I'm not sure we can really know anything about the IND submission date... other than we don't know if/when it was done or will be done.
FWIW, from the info available, I am coming to a subjective conclusion that it was not submitted earlier than the week of July 26th, per my earlier posts. That was based on 8 weeks (6-8 per Joe) from the 5/18 production run (completed per Joe) to receive the stability data, followed by up to 2 weeks for data analysis and IND prep after the stability data was available.
So I am expecting that, if the wheels didn't fall off in some way, the IND approval/feedback WILL be received (and we WILL get news) by the end of August at the latest.
IMO, if that date comes and goes with no update, something has gone awry, even based on the long end of Joe's information to-date.
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