Zolis, This is by no means met to be an insult,
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Posted On: 04/12/2021 2:08:04 PM
Re: Zolis_onkel #28326
Zolis,
This is by no means met to be an insult, but I think that your response could be tainted by a language interpretation. These things I know because my wife is a native German, speaking 4/5 languages. German (native) with native Bavarian dialect, fluent English, Spanish, and French. Each language has their own nuances with some words having no literal direct translation.
You wrote:
Headline
"IND application filed with the FDA to request permission for phase 1+ 2 clinical trials for our Complete Vaccine"
The PR was:
“The protocol has been revised as per FDA request; this submission is to ensure that the revised study design meets the standards of the agency for COVID-19 vaccines, and to confirm that the clinical endpoint analyses of immune system activation, including antibody and T cell responses are acceptable for regulatory approval.”
GNBT has not officially filed the IND. They are still in the process of fine tuning the IND verbiage, protocols, etc. to insure that the IND will meet the FDA final approval standards. Think of this Pre-IND process as a binding contract where the two sides lawyers hash out the details to the nth degree before the final version of the contract is officially signed and becomes legally binding. If GNBT doesn’t get this exactly right, then the company could agree to things (protocols, trial data, etc.) that the FDA wants that may not be relevant or necessary, or perhaps data that is needed for a NDA, but was not specified in the IND agreement.
And as for the “1) It is way too long, and way too technically detailed for my taste.”, readers need to know that this vaccine is something completely different and new. Yes the end results will be the same, but how you get there is different and the most important part. Think of it as getting from Point A to Point B. The current vaccines are like a car, GNBT is like the airplane, with no travel restrictions, like a large body of water (ocean).
This is by no means met to be an insult, but I think that your response could be tainted by a language interpretation. These things I know because my wife is a native German, speaking 4/5 languages. German (native) with native Bavarian dialect, fluent English, Spanish, and French. Each language has their own nuances with some words having no literal direct translation.
You wrote:
Headline
"IND application filed with the FDA to request permission for phase 1+ 2 clinical trials for our Complete Vaccine"
The PR was:
“The protocol has been revised as per FDA request; this submission is to ensure that the revised study design meets the standards of the agency for COVID-19 vaccines, and to confirm that the clinical endpoint analyses of immune system activation, including antibody and T cell responses are acceptable for regulatory approval.”
GNBT has not officially filed the IND. They are still in the process of fine tuning the IND verbiage, protocols, etc. to insure that the IND will meet the FDA final approval standards. Think of this Pre-IND process as a binding contract where the two sides lawyers hash out the details to the nth degree before the final version of the contract is officially signed and becomes legally binding. If GNBT doesn’t get this exactly right, then the company could agree to things (protocols, trial data, etc.) that the FDA wants that may not be relevant or necessary, or perhaps data that is needed for a NDA, but was not specified in the IND agreement.
And as for the “1) It is way too long, and way too technically detailed for my taste.”, readers need to know that this vaccine is something completely different and new. Yes the end results will be the same, but how you get there is different and the most important part. Think of it as getting from Point A to Point B. The current vaccines are like a car, GNBT is like the airplane, with no travel restrictions, like a large body of water (ocean).
(3)
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