Sunday, May 23, 2021 5:10:39 PM
@Sushi @bio @sab @donner @blitzen ...
There is no requirement for relative timing between PR and data being sent to the FDA that I know of. I swear he has said as Sab recalled that it will "immediately go to the FDA followed by PR the next day". I could not locate that specifically, but located the following from "I am Geert Kersten" on Reddit 9 months ago:
https://www.reddit.com/r/IAmA/comments/i8hv6n/i_am_geert_r_kersten_i_have_been_working_in/
Question:
"So what's your plan with who sees data right away when you get it? Will it be a small group looking it over together? Just you first? With so much riding on this I'm fascinated with picturing how it will go down at CEL-SCI."
Geert's Answer:
9 months ago
"After we get the data, we will send it to FDA and make an immediate release."
Question:
imanicole
"I'm presuming FDA will be on the cards first, but are there any plans to seek regualtory approval from other health authorities? And is there currently any data to suggest possible new indications?"
Geert's Answer:
CelSci
9 months ago
"Yes, FDA first, but the study is designed to get approval around the world. The full analysis of the data will yield a treasure trove of information for immunology and head and neck cancer. From that we may find new uses."
AND I HAVE TO REPOST THIS ONE EVEN IF OFF TOPIC:
Question:
AdamsFriends
Hi Geert,
"My name is Adam. As we all know the trial failed years ago and was recommended to be shut down multiple times.
We are wondering when the failure is finally made public and shareholders are left holding a bag of nickles and pennies. What will be your next steps? Will it be to convert into a covid company? Or will you start selling your facilities?
AF"
Geert's Answer:
CelSci
9 months ago
"Adam: I am glad that you know so much more than does the FDA, and 23 other regulators, as well as the IDMC, all of whom have seen the Phase 3 data and somehow have reached opposite conclusion to your statement. At least I put my money where my belief is.
Go play with your doggie."
If anyone knows where the statement of sending PR the next day was made that would be appreciated.
There is no requirement for relative timing between PR and data being sent to the FDA that I know of. I swear he has said as Sab recalled that it will "immediately go to the FDA followed by PR the next day". I could not locate that specifically, but located the following from "I am Geert Kersten" on Reddit 9 months ago:
https://www.reddit.com/r/IAmA/comments/i8hv6n/i_am_geert_r_kersten_i_have_been_working_in/
Question:
"So what's your plan with who sees data right away when you get it? Will it be a small group looking it over together? Just you first? With so much riding on this I'm fascinated with picturing how it will go down at CEL-SCI."
Geert's Answer:
9 months ago
"After we get the data, we will send it to FDA and make an immediate release."
Question:
imanicole
"I'm presuming FDA will be on the cards first, but are there any plans to seek regualtory approval from other health authorities? And is there currently any data to suggest possible new indications?"
Geert's Answer:
CelSci
9 months ago
"Yes, FDA first, but the study is designed to get approval around the world. The full analysis of the data will yield a treasure trove of information for immunology and head and neck cancer. From that we may find new uses."
AND I HAVE TO REPOST THIS ONE EVEN IF OFF TOPIC:
Question:
AdamsFriends
Hi Geert,
"My name is Adam. As we all know the trial failed years ago and was recommended to be shut down multiple times.
We are wondering when the failure is finally made public and shareholders are left holding a bag of nickles and pennies. What will be your next steps? Will it be to convert into a covid company? Or will you start selling your facilities?
AF"
Geert's Answer:
CelSci
9 months ago
"Adam: I am glad that you know so much more than does the FDA, and 23 other regulators, as well as the IDMC, all of whom have seen the Phase 3 data and somehow have reached opposite conclusion to your statement. At least I put my money where my belief is.
Go play with your doggie."
If anyone knows where the statement of sending PR the next day was made that would be appreciated.
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