RJS or somebody w deeper knowledge of the IND subm
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Posted On: 02/24/2021 10:22:35 AM
RJS or somebody w deeper knowledge of the IND submittal process, can you help clarify this statement for me:
"We...plan to submit the IND to the FDA as soon as the GMP production of the Ii-Key vaccine is completed in the coming weeks."
Does the product have to be in hand to SUBMIT the IND application? Or can they submit and deliver the vaccine during the review process?
I realize Joe is managing expectations here. But it seems to me that this statement unfortunately says, "Come back in a few weeks."
Could this statement not have read something like
"We are currently producing the vaccine needed for the Phase I and II trials and finalizing the IND application."
And as Balleroni or someone suggested, add "We will also be shipping vaccine to China as soon as it is available so that we can begin Phase I/II testing under the guidelines of China's FDA as soon as possible."
"We...plan to submit the IND to the FDA as soon as the GMP production of the Ii-Key vaccine is completed in the coming weeks."
Does the product have to be in hand to SUBMIT the IND application? Or can they submit and deliver the vaccine during the review process?
I realize Joe is managing expectations here. But it seems to me that this statement unfortunately says, "Come back in a few weeks."
Could this statement not have read something like
"We are currently producing the vaccine needed for the Phase I and II trials and finalizing the IND application."
And as Balleroni or someone suggested, add "We will also be shipping vaccine to China as soon as it is available so that we can begin Phase I/II testing under the guidelines of China's FDA as soon as possible."
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