Thank you for sharing, biloxiblues. I reached out
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(Total Views: 948)
Posted On: 08/29/2020 11:35:24 AM
Re: biloxiblues #53052
Thank you for sharing, biloxiblues. I reached out to the writer Molly Parker to follow up on Lero. Also reached out to Karen Weintraub from USA Today.
https://www.google.com/amp/s/amp.usatoday.com/amp/5662305002
A poster (doc) from YMB also reached out to Karen regarding Lero and Remdesivir.
“ Mrs. Weintraub,
I am a physician in practice over 21 years and have held numerous leadership roles, participated in numerous industry sponsored trials. You can quickly look at my linked in profile to verify my credentials and connections.
I am, as my other medical colleagues, aghast with the recent decisions from FDA.
I would implore you to look deeper into the relationship of GILEAD with the FDA. There are currently 8 employees of GIL sitting on the FDA Covid 19 task force who can influence decision making re approval (attached).
You can correlate the stock price of GILEAD with insider selling since then.
With the help of these 8 employees, GILEAD was able to push its early approval with data that showed dubious benefit with 3 separate randomized control trials showing different results, in one case NO benefit whatsoever.
Now we have expansion of indication based on "statistically significant uncertain clinical benefits"!
Elsewhere, FDA is putting up fences for new approvals from smaller companies and requiring them higher standard.of proof.
You can review the top of the line results released for a drug LERONLIMAB in its phase 2 trial for mild to moderate patients (only rug trial to use this subset if patient population) which showed CLINICALLY and statistically significant improvement in the treatment arm by 2.5x including improvements in internationally accepted NEWS2 scores and less severe side effects compared to the standard of care. This is all from a drug given 1x/ week through a subcutaneous injection only for 2 weeks only with NO adverse side effects and NO patient exclusions, unlike other drugs.
The drug co CYTODYN requested an EUA based on these results weeks ago but have yet to hear from FDA who seems interested in approving drugs WITHOUT the clinical data indications but based on "trends".
There is also going to be an interim analyses of the phase 3 trial with LERONLIMAB in severe patients with the primary end point of mortality. My sources indicate that there is again a clinically and STATISTICALLY significant improvement in these patients, but FDA will most likely require a larger phase 3 study which will cost much time and lives, again not using the same burden of proof that was required from GILEAD.
Another reason GILEAD would not want Leronlimab approval is because it threatens its cash cow from HiV drugs. GIL up until recently, derived 56% of its profits from HAART meds. Leronlimab was initially found to be efficacious in HIV treatment, undergoing a large trial with 865 pts showing NO SAE and clinically and statistically significant efficacy. They received FDA EUA for HIV treatment as an adjunct in patients with poor response with traditional medicines.
The company filed a HIV BLA with FDA to be used as a monotherapy which has been pushed back several times for "clerical" reasons. If approved, this would be a monumental breakthrough in HIV treatment with once weekly to once monthly subcutaneous injections for HIV pts. This is a multibillion dollar threat to the big pharma in a $30 -50 b/yr industry.
I would encourage you to look into this and expose it for what it is, big pharma cronyism with FDA. When you find these factual accuricies, your most needed report will gain the gratitude of a suffering nation.”
https://www.google.com/amp/s/amp.usatoday.com/amp/5662305002
A poster (doc) from YMB also reached out to Karen regarding Lero and Remdesivir.
“ Mrs. Weintraub,
I am a physician in practice over 21 years and have held numerous leadership roles, participated in numerous industry sponsored trials. You can quickly look at my linked in profile to verify my credentials and connections.
I am, as my other medical colleagues, aghast with the recent decisions from FDA.
I would implore you to look deeper into the relationship of GILEAD with the FDA. There are currently 8 employees of GIL sitting on the FDA Covid 19 task force who can influence decision making re approval (attached).
You can correlate the stock price of GILEAD with insider selling since then.
With the help of these 8 employees, GILEAD was able to push its early approval with data that showed dubious benefit with 3 separate randomized control trials showing different results, in one case NO benefit whatsoever.
Now we have expansion of indication based on "statistically significant uncertain clinical benefits"!
Elsewhere, FDA is putting up fences for new approvals from smaller companies and requiring them higher standard.of proof.
You can review the top of the line results released for a drug LERONLIMAB in its phase 2 trial for mild to moderate patients (only rug trial to use this subset if patient population) which showed CLINICALLY and statistically significant improvement in the treatment arm by 2.5x including improvements in internationally accepted NEWS2 scores and less severe side effects compared to the standard of care. This is all from a drug given 1x/ week through a subcutaneous injection only for 2 weeks only with NO adverse side effects and NO patient exclusions, unlike other drugs.
The drug co CYTODYN requested an EUA based on these results weeks ago but have yet to hear from FDA who seems interested in approving drugs WITHOUT the clinical data indications but based on "trends".
There is also going to be an interim analyses of the phase 3 trial with LERONLIMAB in severe patients with the primary end point of mortality. My sources indicate that there is again a clinically and STATISTICALLY significant improvement in these patients, but FDA will most likely require a larger phase 3 study which will cost much time and lives, again not using the same burden of proof that was required from GILEAD.
Another reason GILEAD would not want Leronlimab approval is because it threatens its cash cow from HiV drugs. GIL up until recently, derived 56% of its profits from HAART meds. Leronlimab was initially found to be efficacious in HIV treatment, undergoing a large trial with 865 pts showing NO SAE and clinically and statistically significant efficacy. They received FDA EUA for HIV treatment as an adjunct in patients with poor response with traditional medicines.
The company filed a HIV BLA with FDA to be used as a monotherapy which has been pushed back several times for "clerical" reasons. If approved, this would be a monumental breakthrough in HIV treatment with once weekly to once monthly subcutaneous injections for HIV pts. This is a multibillion dollar threat to the big pharma in a $30 -50 b/yr industry.
I would encourage you to look into this and expose it for what it is, big pharma cronyism with FDA. When you find these factual accuricies, your most needed report will gain the gratitude of a suffering nation.”
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