poster received fda denial for expedited review and then may file an appeal:
Received denial from FDA for an expedited review of the submitted request under the FOI act. The reason provided for this denial was “You have not demonstrated a compelling need that involves an imminent threat to the life or physical safety of an individual. Neither have you demonstrated that there exists an urgency to inform the public concerning actual or alleged Federal Government activity”.
My response is provided below:
Thanks for your message and for reviewing my request.
I would like to file an appeal as my request is a "compelling need" due to the current pandemic and also pertains to both categories 1) “an imminent threat to the life or physical safety of an individual," and (2) “inform the public concerning actual or alleged Federal Government activity.”
I am providing the reasons why I believe that my request meets the above two requirements:
1. Threat to the life or physical safety of an individual- especially US CITIZENS
a. Currently there are no approved treatments available for critical COVID-19 patients and based on the clinical data from Phase 3 trials, Leronlimab is the only drug that has demonstrated a statistically significant 82% reduction in mortality at 14 days for critically ill COVID-19 patients with 400% improvement in clinical outcome based on an ordinal scale with discharge rate much better in Leronlimab with p-value statistically significant.
b. For Mild-to-moderate phase 2 trials, at the End of Treatment (or Day 14), patients in the Leronlimab group were more than twice as likely to experience a beneficial improvement in The National Early Warning Score (NEWS) compared to patients in the placebo group (50% vs 20%; p=0.0223)
c. Based on the company communications with FDA, they had requested four weekly doses (7,14, 21 &28 days) as the half-life of Leronlimab is only 10 days. However, this request was declined by the FDA and the company had to continue their trials with only two doses (7 and 14 days).
d. As FDA has not given EUA to Leronlimab, the company is being forced to pursue other countries for approval, which will lead to the non-availability of this critical drug to US Citizens due to the limited availability of vials.
2. Inform the public concerning actual or alleged Federal Government activity
a. We strongly believe that FDA actions are biased and not data-driven. FDA has approved EUA for drugs (Remdesivir etc.) that have very high side effects and did not meet the primary endpoints. However, these were manufactured by big pharma with significant clout within the regulatory agencies.
b. We believe that the statement issued by FDA on May 17th was drafted, approved, and published in a rush without taking into consideration the facts.
c. We believe that the statement intentionally did not include the above positive points (#1a -Critical patient data and #1b NEWS endpoints) so that only the negative aspects of Leronlimab were shared with the public and all positives were hidden.
I request you to reconsider the expedited review request so that we can get more answers related to the FDA statement and hopefully save lots of US citizen's lives.
Please feel free to contact me with any questions you may have regarding this matter.
Thanks
Received denial from FDA for an expedited review of the submitted request under the FOI act. The reason provided for this denial was “You have not demonstrated a compelling need that involves an imminent threat to the life or physical safety of an individual. Neither have you demonstrated that there exists an urgency to inform the public concerning actual or alleged Federal Government activity”.
My response is provided below:
Thanks for your message and for reviewing my request.
I would like to file an appeal as my request is a "compelling need" due to the current pandemic and also pertains to both categories 1) “an imminent threat to the life or physical safety of an individual," and (2) “inform the public concerning actual or alleged Federal Government activity.”
I am providing the reasons why I believe that my request meets the above two requirements:
1. Threat to the life or physical safety of an individual- especially US CITIZENS
a. Currently there are no approved treatments available for critical COVID-19 patients and based on the clinical data from Phase 3 trials, Leronlimab is the only drug that has demonstrated a statistically significant 82% reduction in mortality at 14 days for critically ill COVID-19 patients with 400% improvement in clinical outcome based on an ordinal scale with discharge rate much better in Leronlimab with p-value statistically significant.
b. For Mild-to-moderate phase 2 trials, at the End of Treatment (or Day 14), patients in the Leronlimab group were more than twice as likely to experience a beneficial improvement in The National Early Warning Score (NEWS) compared to patients in the placebo group (50% vs 20%; p=0.0223)
c. Based on the company communications with FDA, they had requested four weekly doses (7,14, 21 &28 days) as the half-life of Leronlimab is only 10 days. However, this request was declined by the FDA and the company had to continue their trials with only two doses (7 and 14 days).
d. As FDA has not given EUA to Leronlimab, the company is being forced to pursue other countries for approval, which will lead to the non-availability of this critical drug to US Citizens due to the limited availability of vials.
2. Inform the public concerning actual or alleged Federal Government activity
a. We strongly believe that FDA actions are biased and not data-driven. FDA has approved EUA for drugs (Remdesivir etc.) that have very high side effects and did not meet the primary endpoints. However, these were manufactured by big pharma with significant clout within the regulatory agencies.
b. We believe that the statement issued by FDA on May 17th was drafted, approved, and published in a rush without taking into consideration the facts.
c. We believe that the statement intentionally did not include the above positive points (#1a -Critical patient data and #1b NEWS endpoints) so that only the negative aspects of Leronlimab were shared with the public and all positives were hidden.
I request you to reconsider the expedited review request so that we can get more answers related to the FDA statement and hopefully save lots of US citizen's lives.
Please feel free to contact me with any questions you may have regarding this matter.
Thanks
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