Yeah, I guess I wasn’t looking for Generex-speci
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Posted On: 08/08/2021 12:51:34 PM
Yeah, I guess I wasn’t looking for Generex-specific information. I was wondering what the “typical” scenario for this might be, so that I might make a guess at timing of the IND submission.
I’m not sure of what value this info would be. But let’s say hiring a CRO typically is done after all the preliminary info is gathered and the IND is submitted. That would indicate a likelihood that the IND was submitted before 7/22 (perhaps even a week or two earlier, if you assume negotiation time for the CRO contract).
Conversely, if the CRO typically provides significant input for the IND, maybe the IND has yet to be submitted, as they were only hired a couple of weeks ago.
Probably not anything that guides us definitively, but I thought I’d try to understand the process a little better. I didn’t find anything that provided too much certainty/clarity in my initial Google search…
If I had to make a layman’s guess after reading a bit about CROs, my thought would be that a company such as Generex, with limited experience with this sort of thing, would need/want the CRO involved in some of the up-front work on the IND.
On one hand, I hope I am wrong on that, as it would indicate that the IND may not have been submitted yet.
On the other hand, what are the odds the design was done flawlessly if the right minds were not engaged in the process?
And so we wait…
I’m not sure of what value this info would be. But let’s say hiring a CRO typically is done after all the preliminary info is gathered and the IND is submitted. That would indicate a likelihood that the IND was submitted before 7/22 (perhaps even a week or two earlier, if you assume negotiation time for the CRO contract).
Conversely, if the CRO typically provides significant input for the IND, maybe the IND has yet to be submitted, as they were only hired a couple of weeks ago.
Probably not anything that guides us definitively, but I thought I’d try to understand the process a little better. I didn’t find anything that provided too much certainty/clarity in my initial Google search…
If I had to make a layman’s guess after reading a bit about CROs, my thought would be that a company such as Generex, with limited experience with this sort of thing, would need/want the CRO involved in some of the up-front work on the IND.
On one hand, I hope I am wrong on that, as it would indicate that the IND may not have been submitted yet.
On the other hand, what are the odds the design was done flawlessly if the right minds were not engaged in the process?
And so we wait…
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