In the last CC, Joe mentioned PPD numerous times. PPD was instrumental in filing the IND (or soon to be filed if not yet), and will be in setting up the Phase I study in 159 patients. So it appears continuous and interesting that a new agreement was signed as noted in the recent 8k.
“ The only other thing they asked us for was a simple immunogenicity study with transgenic mice. So, it's probably one of the cleanest responses that I’ve ever seen in a full package pre-IND package; and we've answered all those questions, we submitted all the answers to those questions to the FDA, and we are now cleared to put our IND in. So, once our manufacturing of the complete vaccine for commercial use is done on May 18th, all the rest of the answers which are required to put into the IND package will be complete; and then PPD Worldwide, our other partner, will put that into the remaining parts of the package that this information needs to go in, the certified reports all the testing, all the stability, all that will go in and we're pretty confident that we will have a green light to get to a very, very small--it'll take us one month to get that Phase 1 done and we'll have the answers at that point. And if it matches up to our ex vivo human trials, we have a home run here.”
“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,..”
“So, that should be our quickest part of the process which is the trials; we have PPD worldwide which is the best, I believe, in the business that handles clinical trials and government relations, so we're with all the right companies to get it done quickly once we get the IND.”
PPD
https://www.ppd.com/
“ The only other thing they asked us for was a simple immunogenicity study with transgenic mice. So, it's probably one of the cleanest responses that I’ve ever seen in a full package pre-IND package; and we've answered all those questions, we submitted all the answers to those questions to the FDA, and we are now cleared to put our IND in. So, once our manufacturing of the complete vaccine for commercial use is done on May 18th, all the rest of the answers which are required to put into the IND package will be complete; and then PPD Worldwide, our other partner, will put that into the remaining parts of the package that this information needs to go in, the certified reports all the testing, all the stability, all that will go in and we're pretty confident that we will have a green light to get to a very, very small--it'll take us one month to get that Phase 1 done and we'll have the answers at that point. And if it matches up to our ex vivo human trials, we have a home run here.”
“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,..”
“So, that should be our quickest part of the process which is the trials; we have PPD worldwide which is the best, I believe, in the business that handles clinical trials and government relations, so we're with all the right companies to get it done quickly once we get the IND.”
PPD
https://www.ppd.com/
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