Sunday, February 28, 2021 8:44:27 PM
The roadmap for the FDA to issue an EUA (emergency use authorization) for a therapeutic drug is VERY interesting in relation to RVV….See this example of one of their few approvals.
1. In June 2020 Eli Lilly Starts Study on Therapeutic cocktail - Study to be 3300 participants.
https://clinicaltrials.gov/ct2/show/NCT04427501
2. On 1-21-2021 Results were published in a Medical Journal for 577 patients
https://jamanetwork.com/journals/jama/fullarticle/2775647?guestAccessKey=3fec263c-09fb-401a-b5b9-3691cf340d8b&utm_source=For_The_Media&utm_medium=referral&utm_campaign=ftm_links&utm_content=tfl&utm_term=012121
3. On 1-26-2021 Lilly Publishes additional Data showing Strong Efficacy on 1035 Patients treated
https://investor.lilly.com/news-releases/news-release-details/new-data-show-treatment-lillys-neutralizing-antibodies
4. On 2-9-2021 FDA AUTHORIZES EUA. Based on data from 1035 Patients (less than 1/3 of their study complete)
https://www.prnewswire.com/news-releases/lillys-bamlanivimab-ly-cov555-administered-with-etesevimab-ly-cov016-receives-fda-emergency-use-authorization-for-covid-19-301225460.html
5. Lilly Study continues on to complete the original full 3300 Patient Study
6. RVV- Revive has told us it has competed treatment on 210 of the 1000 total patients for their phase 3 study on Bucillamine. The Data Safety Monitoring Board reviewed both the safety and efficacy of these patients and gave RVV the green light to continue and expand the number of trial sites from 14 to 50. Would they have issued a green light to expand such a trial so aggressively if results weren’t positive?
7. In the press release on 2-26-2021. RVV stated they will release Efficacy data on first 400 patients in Q1 (1 more month at latest). If these are positive on 40% of the trial complete, the FDA, based on the example of the only other therapeutic they have issued an EUA on, could issue RVV an EUA in weeks after the 400 patient results are announced based on their history shown above.
8. You do the math, what is the world’s first oral therapeutic for mild Covid treatment worth in a global pandemic? Hint….It starts with a “B” and has 3 commas…
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