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Posted On: 08/09/2021 12:19:35 PM
Post# of 36541
If this was done back in the beginning of July based on what Joe stated and they partnered then with PPD, should we be hearing something soon from the FDA on whether the IND has been approved or not? I thought I heard that it gets approved after 30 days automatically if the FDA doesn't do anything or am I wrong? But, shouldn't we hear something either way now that it is August 9th?
So, Ii-Key is going to be protected for a much longer time; I can address the clinical trial questions, we're filing the IND by the end of June--the first day of July is the latest that we can possibly do it as far as I’m concerned on my internal timeline, anyway --and we expect to be able to initiate our Phase 1 trial with 159 patients targeted based upon the FDA's approval of the protocol; they have it, we submitted that protocol to them.
And it's a very complex and complicated protocol that PPD helped us put together,..”
Read More: https://investorshangout.com/post/view?id=620...z733s9QvEv
So, Ii-Key is going to be protected for a much longer time; I can address the clinical trial questions, we're filing the IND by the end of June--the first day of July is the latest that we can possibly do it as far as I’m concerned on my internal timeline, anyway --and we expect to be able to initiate our Phase 1 trial with 159 patients targeted based upon the FDA's approval of the protocol; they have it, we submitted that protocol to them.
And it's a very complex and complicated protocol that PPD helped us put together,..”
Read More: https://investorshangout.com/post/view?id=620...z733s9QvEv
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