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Re: CallMeCrazy post# 361807

Monday, 06/07/2021 12:13:32 PM

Monday, June 07, 2021 12:13:32 PM

Post# of 404015
Given the revenue potential for 2021 that you cite, would you expect that IPIX management would be pressing the FDA to relax the protocol to collect the final piece of data at day 60?

The DMC will have 60-day data on at least 84 of the subjects and all of the other “Primary”, “Secondary”, and “Other” endpoints will be met at day 29. To sit idle while the clock runs for an extra 30 days (representing >20% of the available revenue-generating time in 2021) is negligent imo.

The 60 day telephone call was put in during trial development when IPIX expected the trial would fill quickly (perhaps a week or two). Now that the trial has taken 4 months to recruit, the 60 day telephone call looks misguided and deserves to be pursued with the FDA by IPIX management.

Here’s my post from this weekend about this subject.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=164230458

BTW -- We're in real trouble if the 60 day telephone call is really necessary since that means that IPIX is aware of lingering effects of brilacidin. We have been led to believe that any TRAEs of brilacidin were transient and resolved shortly after treatment. This 60-day call is 55 days after treatment ends.