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Very interesting if true
Isn’t the longhauler market much bigger than Covid critical?
Reversal confirmed to close the gap from $4 perhaps? Volume is good. Squeeze out some sharts?
Looks like the capitulation point may be passing.
MIA
I suspect Amarex is a big part of the problem. I said so in an email to NP and SK, following the Lost data comment by NO on the HIV BLA, shortly afterward Mahboob was hired.
Giddyup!
Thanks Tom.
Perhaps this is completion of capitulation.
Mrahman@cytodyn.com
I’ll be Phizer spent PLENTY of resources studying occupancy of Maraviroc in HIV before concluding that.
Excellent point about no receptor occupancy correlation with Maraviroc in HIV. Probably the same with Leronlimab. Mahboob is beating his head against the wall for no good reason.
Courtesy of John Bream, MD (Bream Medical Group)
Fellow shareholders,
I took the liberty of re-writing Cytodyn's press release from Friday. Note, this took me 23 minutes to do. Seriously.
Vancuover, Washington – CytoDyn (“the company”) is pleased to release the analysis of its CD-12 trial.
Due to an over-enrollment of patients greater than 65-years-old in the leronlimab arm, a modified intention-to-treat (mITT) analysis was performed to standardize the data. The mITT analysis of CD-12 yielded the following statistically significant results of primary and secondary endpoints:
1) When leronlimab was used in additional to “commonly used COVID-19 treatments” a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 6.5% with a relative risk reduction of death of 28.1% (N = 309, p = .0319).
2) When leronlimab was used in combination with dexamethasone, a clear benefit was seen in the primary endpoint of all-cause mortality at day 28 with an absolute risk reduction of death of 5.7% with a relative risk reduction of 26.2% (N=233, p=.055)
3) The mean length in hospital stay was decreased by 5.5 days in the critically ill population (p = .005)
4) Mortality status at day 28 when leronlimab was used in addition to “commonly used COVID-19 treatments” in the critically ill population with an age < 65 showed a clear mortality benefit with an absolute risk reduction of death of 20.9% with a relative risk reduction of death of 73% (N=40, p=.03)
5) Mortality status at day 28 when leronlimab was used in addition to dexamethasone in the critically ill population showed a clear mortality benefit with an absolute risk reduction of death of 6.5% and a relative risk reduction of death of 23.5% (N=35, p=.04)
6) Length of hospital stay in critically ill patients < 65-years-old showed a clear benefit with a reduction of 6.8 days (N=44, p=.006)
In addition, there were no safety signals seen in the leronlimab group versus placebo.
Based on this data, the company looks forward to regulatory talks with the FDA, MHRA, Health Canada, the Philippines, and Brazil as we believe the data supports the use of leronlimab worldwide. The company will hold a call on Monday March 8th at 4pm ET/1pm PT to discuss these results further.
The really sad thing is that Brian Brothen actually has a degree in professional communications, but I guess nobody at Cytodyn cares about that.
But not Leronlimab if it’s not approved for anything by FDA.
Your point about not approving this drug and requiring a CD16 trial costing lives is valid. Let’s optimistically say 90 days x 2000/day x .25= 45,000 lives lost. But what if there is another “surprise” with the trial data, what will that cost? It seems NP is too cavalier in his supreme optimism of success, when he really needs to have a more humble and cautious attitude after so many trials and no approvals or sales. Seems to me they should consider something for severe under 65 as some insurance.
how will they convince patients to expose themselves to placebo when an OLE is in progress where they get the leronlimab?
Where did the 3:1 vs 2:1 thing with the DSMC come from? Can anyone explain that?
Trial enrollment details are blinded to all except the CRO, CRO plays crucial role in trial design, correct? If so, why does Amarex have no responsibility?
The science is very strong. This is a trial design blunder! Not age matching controls? https://t.co/gLAXNAxsq4
— Bruce K. Patterson MD (@brucep13) March 8, 2021
What action will or can Cytodyn take to expedite this enrollment?
What action will or can Cytodyn take to expedite filing the HIV BLA’s???
How quickly can those 140 be enrolled?
Maybe some politicians and regulators will be asked some questions.
You’ve made a lot of right calls in the past. Unlike many on this board, you’re straight in what you say and don’t try to manipulate sentiment by twisting information. I trust your judgment.
Covid is a complex disease, poorly understood, and many layers of information can be revealed here about it with thus therapeutic that actually works.
https://m.canadianinsider.com/cytodyn-to-file-accelerated-rolling-review-with-mhra-and-interim-order-io-with-health-canada-for-covid-19
Dudley DoRight defeats Snively Whiplash.
Nice note, we can only hope she will actually read it.
Contact Dan Vergano at dan.vergano@buzzfeed.com. He needs statements like that from physicians like you to unmask the criminals at FDA
God Bless you! It Is Safe. It is the most effective at saving lives.
Withholding it from Americans is UNETHICAL and IMMORAL.
What is your prognosis on volume Monday, given the events Since Friday night?
Rock, that would be a terrible loss.
It is crap.
It is likely that a journal article is in progress, and if so, a good reason why much of the data is not yet PR’d. There is enough PR’d to indicate an EUA is likely.