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Re: Whalatane post# 20167

Friday, 09/11/2020 9:58:21 PM

Friday, September 11, 2020 9:58:21 PM

Post# of 44690
Here's the pre-print for the 19/21
https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3665228


And the pre-print for the 6/6
https://www.preprints.org/manuscript/202008.0640/v1


And the Clinical Trials...

List: https://clinicaltrials.gov/ct2/results?term=Aviptadil&draw=2&rank=1#rowId0

• Clinical Trial NCT04311697 – The initial clinical trial underway to test intravenously administered drug. Approximately 86 out of 122 patients have been recruited as of Aug 12, and the company’s data committee will begin reviewing the cases once they reach 102 patients. From there, they will present findings to the FDA. Speculation: Review could begin this week of 8/24; however, official publication of results could take several more weeks, but likely before October, due to Javitt’s comments about being able to ramp up production by October.

• Clinical Trial NCT04453839 – The FDA-approved Expanded Access program for treating patients who are too sick for clinical trials.

• Expanded Access results were released in a “pre-print” document, showing 19 of 21 patients have survived. These are the sickest of the sick (ICU, ventilators, ECMO patients). The pre-print is under peer review & expected to be officially released in the coming weeks.

• Clinical Trial NCT04360096 – A study of 288 patients to test an inhaler-version of RLF-100, intended to ultimately be used for in-home treatments. Estimated completion of trial is November 30th. According to Dr. Javitt: “We expect that half the people we enroll in our inhaled study are going to be people who are outpatients.”

• Clinical Trial NCT04536350 – A study of 80 patients in Switzerland to test an inhaler-version of RLF-100 as a preventative treatment.


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