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Re: To infinity and beyond! post# 366811

Sunday, 07/25/2021 12:05:27 PM

Sunday, July 25, 2021 12:05:27 PM

Post# of 403047
We have no idea as to what the trial results look like since results have not yet been unblinded. Please stop making definitive factual statements about the result of the trial.

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.
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