Humbled by FDA Protocols for Type A Meetings...
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Posted On: 08/20/2020 7:57:31 AM
Humbled by FDA Protocols for Type A Meetings...
I have been pondering on whether a WRO in lieu of a teleconference is better or worst and why highlight that in the PR. Well I figured I do some research as to the typical course of action by the FDA during these times and found the below listed interestings guidelines from the FDA.
After reviewing them it seems the Written Response Only (WRO) type of meetings are FDA's preference during these times in order to manage the load of companies and therapeutics as well as to expedite the approval process as the info requested or discussed revolves already statistical and scientific data. This is not a marketing call if you will but a true dive into data, numbers, figures, calculations, etc, etc.
Now when you combine the other PR about UK granting enrollment into P3, one has to wonder if that invendartly pressed FDA to change from a teleconference to a WRO tp expedite this process.
I for one have been extremely critical of the perceived handling of the PRs, timeline, etc but in reviewing these docs I must admit I was quite humbled. It was pressed upon me the magnitude of what we are talking about here and the amount of work, personnel and time is involved by scientists, doctors, fda employees, etc to bring an idea to dev to trial to approval to market to drs and finally to patients. We are talking about foreign substances we are injecting into the human body.....what an extraordinary endeavor.
So while Cytodyn started out as a simple 4 letter word on my alert some few months back, I have to say it is much much more. Sure I am eager to enjoy its profit but more than that I am proud to have helped just a little bit with my small investment. Even if no approval is ever ever given, to those in the trials and to those that have gotten emergency use, my little investment was part of THEM getting better. Those patients got to go back to their families, kids, wives, parents and to their life. What an extraordinary things I and we are a part of....We are part of the oldest practice in the world, we are part of history.
Anthony C
https://www.fda.gov/media/137927/download
"COVID-19 Public Health Emergency: General Considerations for Pre-IND
Meeting Requests for COVID-19 Related Drugs and Biological Products
https://www.fda.gov/media/109951/download
"Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry"
https://www.fda.gov/media/94850/download
"Best Practices for Communication Between IND Sponsors and FDA During Drug Development"
I have been pondering on whether a WRO in lieu of a teleconference is better or worst and why highlight that in the PR. Well I figured I do some research as to the typical course of action by the FDA during these times and found the below listed interestings guidelines from the FDA.
After reviewing them it seems the Written Response Only (WRO) type of meetings are FDA's preference during these times in order to manage the load of companies and therapeutics as well as to expedite the approval process as the info requested or discussed revolves already statistical and scientific data. This is not a marketing call if you will but a true dive into data, numbers, figures, calculations, etc, etc.
Now when you combine the other PR about UK granting enrollment into P3, one has to wonder if that invendartly pressed FDA to change from a teleconference to a WRO tp expedite this process.
I for one have been extremely critical of the perceived handling of the PRs, timeline, etc but in reviewing these docs I must admit I was quite humbled. It was pressed upon me the magnitude of what we are talking about here and the amount of work, personnel and time is involved by scientists, doctors, fda employees, etc to bring an idea to dev to trial to approval to market to drs and finally to patients. We are talking about foreign substances we are injecting into the human body.....what an extraordinary endeavor.
So while Cytodyn started out as a simple 4 letter word on my alert some few months back, I have to say it is much much more. Sure I am eager to enjoy its profit but more than that I am proud to have helped just a little bit with my small investment. Even if no approval is ever ever given, to those in the trials and to those that have gotten emergency use, my little investment was part of THEM getting better. Those patients got to go back to their families, kids, wives, parents and to their life. What an extraordinary things I and we are a part of....We are part of the oldest practice in the world, we are part of history.
Anthony C
https://www.fda.gov/media/137927/download
"COVID-19 Public Health Emergency: General Considerations for Pre-IND
Meeting Requests for COVID-19 Related Drugs and Biological Products
https://www.fda.gov/media/109951/download
"Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry"
https://www.fda.gov/media/94850/download
"Best Practices for Communication Between IND Sponsors and FDA During Drug Development"
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