Here is another thought filled with facts. Fac
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Posted On: 10/16/2020 12:57:12 AM
Here is another thought filled with facts.
Fact #1 We would have to show some type of mortality reduction for the trial to continue.
Fact #2 We saw plenty of anecdotal data that leronlimab was doing what no other drug could do which was saving lives reducing mortality.
Fact #3 Nadar kinda put himself in a situation to give a PR by Tom when he want on national tv Fox Business News and stated hopefully big news by Friday. We will learn Tuesday or possible Before Tuesday what recommendation was but the ball may be in FDA’s court as we speak and what slides are we going to see on Tuesday? New ones did cytodyn receive data from the interim maybe unblinded so that they can moved toward a potential regulatory approval other than the norm of finishing trail till 390. What is there to discuss about finishing a trail that would be a quick conversation “we were advised to finish out trial” doesn’t seem likely that is all that will be said
Fact #4 if we’re showing Enough mortality Reduction to finish out trail than DSMC May be giving recommendations based on non pandemic parameters such as if we were trying to get approval of a blood pressure drug the circumstances for a trail halt would be very slim since would
Need excellent super super low pvalue, well here the thing we’re in a pandemic and there is a HUGE unmet need for a SAFE mortality reducing live saving drug. Will FDA say thanks for your recommendation DSMC and throw our data to the side of will they look at it and see if we’re anywhere close to Steven Hahn head of FDA “dream“ mortality reduction number of 35%? We would have to be atleast 15% mortality reduction for DSMC to recommend continue trial so if we are even slightly higher than that I couldn’t easily see that were waiting on an FDA EUA Approval decision as the potential regulatory path forward.
Fact #5 I’m tired Going to bed zzzzzzzzzzzz ans will be buying more shares tom, this is gonna be good knees no matter which way you slide it if your al little impatient and can’t wait for possible EUA or MHRA or Phillipines or full approval in 3 months when your shares and money will likely be 4x - 6x current prices. Covid isn’t going anywhere until prob late next year. CYDY hiv BLA will be submitted hopefully by EOY and revenue will be cling in from that as soon as 4/6,‘months after PDUFA date.
Fact #1 We would have to show some type of mortality reduction for the trial to continue.
Fact #2 We saw plenty of anecdotal data that leronlimab was doing what no other drug could do which was saving lives reducing mortality.
Fact #3 Nadar kinda put himself in a situation to give a PR by Tom when he want on national tv Fox Business News and stated hopefully big news by Friday. We will learn Tuesday or possible Before Tuesday what recommendation was but the ball may be in FDA’s court as we speak and what slides are we going to see on Tuesday? New ones did cytodyn receive data from the interim maybe unblinded so that they can moved toward a potential regulatory approval other than the norm of finishing trail till 390. What is there to discuss about finishing a trail that would be a quick conversation “we were advised to finish out trial” doesn’t seem likely that is all that will be said
Fact #4 if we’re showing Enough mortality Reduction to finish out trail than DSMC May be giving recommendations based on non pandemic parameters such as if we were trying to get approval of a blood pressure drug the circumstances for a trail halt would be very slim since would
Need excellent super super low pvalue, well here the thing we’re in a pandemic and there is a HUGE unmet need for a SAFE mortality reducing live saving drug. Will FDA say thanks for your recommendation DSMC and throw our data to the side of will they look at it and see if we’re anywhere close to Steven Hahn head of FDA “dream“ mortality reduction number of 35%? We would have to be atleast 15% mortality reduction for DSMC to recommend continue trial so if we are even slightly higher than that I couldn’t easily see that were waiting on an FDA EUA Approval decision as the potential regulatory path forward.
Fact #5 I’m tired Going to bed zzzzzzzzzzzz ans will be buying more shares tom, this is gonna be good knees no matter which way you slide it if your al little impatient and can’t wait for possible EUA or MHRA or Phillipines or full approval in 3 months when your shares and money will likely be 4x - 6x current prices. Covid isn’t going anywhere until prob late next year. CYDY hiv BLA will be submitted hopefully by EOY and revenue will be cling in from that as soon as 4/6,‘months after PDUFA date.
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