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Posted On: 08/08/2021 12:03:21 AM
Post# of 36541
Rjs, can you share any knowledge you might have on this question?
If we assume, for discussion purposes, that the IND has been submitted, where does the signing of the deal with PPD (on 7/22) fit into the timeline?
Would the signing of this deal most likely be something that:
A). occurred before the IND submission as part of the IND package,
. was tacked onto an already filed IND at the request of the FDA, ie, was something that was missing from our initial submission, or
C). was done after the IND submission as part of Generex’s preparation for approval/testing and was not done at the specific request of the FDA in relation to the IND?
Thanks for any thoughts you might have on this!
If we assume, for discussion purposes, that the IND has been submitted, where does the signing of the deal with PPD (on 7/22) fit into the timeline?
Would the signing of this deal most likely be something that:
A). occurred before the IND submission as part of the IND package,
. was tacked onto an already filed IND at the request of the FDA, ie, was something that was missing from our initial submission, or C). was done after the IND submission as part of Generex’s preparation for approval/testing and was not done at the specific request of the FDA in relation to the IND?
Thanks for any thoughts you might have on this!
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