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Posted On: 04/14/2021 6:13:21 PM
Post# of 36563
Hylander,
NGIO/GNBT is not submitting a new Pre-IND, they are just using the existing Pre-IND to tweak things before the IND is officially submitted. Think of it as a Pre-Nuptial. The two going to be married persons, get together with their lawyers and hash out the agreement/contract. Once it is signed and the two are legally married, then it is “game over” with no “backsies”. Same applies with the IND. Whatever is in the IND test protocols and outcomes is fixed. GNBT/NGIO doesn’t get an “oh crap” what we really wanted to do/say in our IND was… So I see this FDA request as a good thing, and that they (FDA) wants the Ii-key vaccine to have the best chance of succeeding.
NGIO/GNBT is not submitting a new Pre-IND, they are just using the existing Pre-IND to tweak things before the IND is officially submitted. Think of it as a Pre-Nuptial. The two going to be married persons, get together with their lawyers and hash out the agreement/contract. Once it is signed and the two are legally married, then it is “game over” with no “backsies”. Same applies with the IND. Whatever is in the IND test protocols and outcomes is fixed. GNBT/NGIO doesn’t get an “oh crap” what we really wanted to do/say in our IND was… So I see this FDA request as a good thing, and that they (FDA) wants the Ii-key vaccine to have the best chance of succeeding.
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