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midastouch017

07/25/20 11:47 AM

#1513 RE: peterus #1512

whats the time frame to get news back from FDA ?



A very good question. Here are
the various possibilities:

An IND application may go into effect: 30 days
after FDA receives the application, unless FDA
notifies the sponsor that the investigations
described in the application are subject to a
Clinical Hold; or. on earlier notification by
FDA that the clinical investigations in the
IND may begin.

The positive point in the subject is that:

Can-Fite BioPharma Ltd. (NYSE American:CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, announced today that it has amended its Phase II COVID-19 study protocol based on inputs from the U.S. Food and Drug Administration (FDA) and its Pre-Investigational New Drug (IND) filing. The Company plans to file an IND application with its completed protocol before the end of July.



Quote from:

#msg-157023021

The meaning is that negotiations between CANF and the FDA
took place prior to the filing, and as a result CANF amended
the filing according FDA guidelines, hence much better chances
of filing going into effect within 30 days, OR even earlier!

First comes first, let's wait for the filing announcement!

:-)