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Posted On: 11/05/2020 5:41:22 PM
Post# of 148908
So biggest things revealed on Today’s conference call are as follows
#1 statisticians have provided CD-12 data to FDA.
#2 OWS has been in discussions with CYDY and that EAU is on the table especially since FDA now has our data. Expectation is if we get EUA for CD-12 we should get OWS funding help and manufacturing.
#3 We also have a unnamed billionaire that if data shows reduces mortality he will personally step in and help with funding.
#4 Heavily focused on getting to 293 enrollment currently near 250, significant person Brian B. going around to many of the hospital sites to get us listed as priority.
#5 BLA is being worked on for U.K submission still seen as quickest path for approval
#6 Long Haulers FDA trial protocol being fine tuned to best position CYDY for future vital indications hopefully submit in a week or so.
#7 Canada meeting for HIV next week!
#8 Nash hope to enroll patients this year
#9 what lawsuits? Oh Bogus investigations what they are
Would like to see things like trial enrollment and BLA submission sped up more but overall very good call! Can’t wait for EUA to be announced out of nowhere any day now that FDA has our cd-12 inter data of 195. Remember FDA has states any drug that showed there maybe benefit that was more importantly safe could be approved for EUA. The saftey of leronlimab has never been in question and now that FDA is sitting on our cd-12 results and the fact DSMB continued trial with no recommended changes put us in what I think should be 99.9% EUA provided there’s plenty of data to support efficiency and safety. Looks like all the pieces finally coming together. “Don’t Blink”
#1 statisticians have provided CD-12 data to FDA.
#2 OWS has been in discussions with CYDY and that EAU is on the table especially since FDA now has our data. Expectation is if we get EUA for CD-12 we should get OWS funding help and manufacturing.
#3 We also have a unnamed billionaire that if data shows reduces mortality he will personally step in and help with funding.
#4 Heavily focused on getting to 293 enrollment currently near 250, significant person Brian B. going around to many of the hospital sites to get us listed as priority.
#5 BLA is being worked on for U.K submission still seen as quickest path for approval
#6 Long Haulers FDA trial protocol being fine tuned to best position CYDY for future vital indications hopefully submit in a week or so.
#7 Canada meeting for HIV next week!
#8 Nash hope to enroll patients this year
#9 what lawsuits? Oh Bogus investigations what they are
Would like to see things like trial enrollment and BLA submission sped up more but overall very good call! Can’t wait for EUA to be announced out of nowhere any day now that FDA has our cd-12 inter data of 195. Remember FDA has states any drug that showed there maybe benefit that was more importantly safe could be approved for EUA. The saftey of leronlimab has never been in question and now that FDA is sitting on our cd-12 results and the fact DSMB continued trial with no recommended changes put us in what I think should be 99.9% EUA provided there’s plenty of data to support efficiency and safety. Looks like all the pieces finally coming together. “Don’t Blink”
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