Monday, May 31, 2021 7:25:16 PM
'farrell90' said:
IMO, Leo should already have the EUA prepared, awaiting phase 2 results (whatever they are) for inclusion in the application. The goal here is to make the EUA COVID treatment billion$ in the same way Pfizer made dozens of billion$ on their EUA vaccine, mainly by creating the first effective and approved vaccine.
IPIX doesn't need to waste precious time doing a phase 3. Look at the FDA's 'Evidence of Efficacy' requirement and how it reads:
https://www.fda.gov/media/97321/download
Brilacidin can meet these standards and go on to earn an EUA with the U.S. Government as a probable first contract worth hundreds of millions, if not billions.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=163549419
This is a time for business development not pipeline development. Leo should be lining-up manufacturing capacity so that when the EUA is issued IPIX can start writing and filling contracts, all the while trying to secure EUAs in as many countries as possible. There are billions of dollars to be made with an EUA for COVID treatment, provided IPIX is among the first few to get it.
Big Pharma understands the need for speed and this explains why Pfizer began a phase 1 study of a protease inhibitor for COVID treatment in March 2021 and expects to have it available in oral form by end-of year 2021. That's "warp speed" fast.
https://www.cnbc.com/2021/04/27/pfizer-at-home-covid-pill-could-be-available-by-year-end-ceo-albert-bourla-says.html
But orally isn't the only way Pfizer wants to treat COVID:
https://www.pfizer.com/news/press-release/press-release-detail/pfizer-initiates-phase-1-study-novel-oral-antiviral#:~:text=Footer%20Aside%20Section1-,Pfizer%20Initiates%20Phase%201%20Study%20of%20Novel%20Oral,Agent%20Against%20SARS%2DCoV%2D2
Apparently, Pfizer plan to file for a EUA after only a phase 1. But why not? There's no EUA requirement for any particular phase of clinical trials to be completed. Pfizer and other BP are trying desperately to cash in on the lower efficacy standard for a EUA. Lower standards, quicker cash This is what IPIX should be doing.
IMO, IPIX doesn't need grant money or a phase 3. IPIX needs a business strategy involving partnering with manufacturing entities and others to build a global portfolio of EUAs for B-COVID in order to maximize global profits.
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