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Sunday, July 25, 2021 12:05:27 PM
Also, we are subject to the guidance of the FDA.
COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry
http://www.fda.gov/media/137926/download
You may also find page 9 to be of interest. It may explain why the company initially stated there would be an interim report, but has since abstained:
FDA strongly discourages disseminating data from ongoing trials. Knowledge of accumulating data by trial investigators and patients can adversely affect patient accrual, adherence, and retention, as well as endpoint assessment, compromising the ability of the trial to reliably achieve its objective in a timely manner.
The trial is ongoing with secondary endpoints being measured out to 60 +/- 10 days.
https://clinicaltrials.gov/ct2/show/NCT04784897
The study is comprised of three parts:
...
3. Follow-up period (Day 4-6 through Day 60): Subjects will be assessed daily while hospitalized. Discharged patients will be asked to attend study visits at Days 15 and 29. A follow-up visit at Day 60(±10), by telephone call, is also included to confirm patient status.
Secondary Outcome Measurement
10. Incidence of treatment-emergent adverse events [ Time Frame: Day 1 through Day 60 ]
Treatment-emergent Adverse Events (TEAEs) have onset dates on or after the study treatment start date
So the trial is still ongoing per the protocol agreed upon by the FDA. The company said results would be unblinded after completion of the trial protocol in early August.
Go IPIX!
Hodling IPIX with Diamond Paws since 2015.
Honorary IPIX Soft Pumper: Dream big...woah, woah, woah! Not that big.
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