Innovation Pharmaceuticals Inc (IPIX)

[loanranger]

"Left out the comments was reference to the TOTAL FDA WAITING PERIOD OF 60 Days (inclusive of the 29-day patient follow-up):"

There is no TOTAL FDA WAITING PERIOD OF 60 Days.

if your source for that is the FDA's COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Guidance for Industry you'll see that 24 of its pages begin with the heading "Contains Nonbinding Recommendations".

That said, the Guidance Document makes reference to the phrase "60 days" as follows:
In a trial in severe and/or critically ill patients, examples of appropriate endpoints could be:
?All-cause mortality at an appropriate time point (e.g., at least 28 days for hospitalized noncritically ill patients,27 60 days for critically ill patients28)

?Proportion of patients alive and free of respiratory failure at an appropriate timepoint (e.g., at least 28 days for hospitalized noncritically ill patients, 60 days for critically ill patients)

?Clinical status using an ordinal scale that incorporates multiple clinical outcomes of interest (e.g., death, mechanical ventilation) ordered by their clinical importance at an appropriate time point (e.g., at least 28 days for hospitalized noncritically ill patients, 60 days for critically ill patients)29
https://www.fda.gov/media/137926/download

Recommendations are just that...they aren't requirements.
FYI "e.g" means example.
There is no WAITING PERIOD of 60 days for data release or patient follow up requirement of 60 days imposed by the FDA.

Link your source if you have one.


Meanwhile, the Primary Endpoints will be measurable some time around the 4th of July.