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Saturday, August 08, 2020 2:24:50 AM
I have been doing some DD on RV*TF and their drug BUC (an arthritis drug that has been repurposed for the treatment of COVID)
A couple months ago they started their discussions with the FDA (and get this:) the initial discussion was about a phase 2 trial but due to the excellent safety profile (BUC has been used for 30 years for another indication without safety concerns).. the FDA recommended that the company file the paperwork to immediately go into phase 3 trials instead.
Due to an excellent safety profile (sound familiar?).. and the analyst writing the report (that I read) also attributed this recommendation by the FDA as part of the urgency to get treatments for this virus.
Now put this in the context of where we are at today with IPIX - How in the world could the FDA make any kind of exceptional move forward (as they did with BUC) without the full data from the RBLs?.. which is what we are ALL waiting for and due in the coming weeks. In the above case (where the FDA recommended RV*TF skip phase 2 and go directly to phase 3) the FDA seemed to have made the decision on the spot after being informed by the company.
Now I am not raising expectations.. and an initiated phase 2 for COVID will be very positive for IPIX and shareholders (and once we get into the phase 2.. data acquired during the trial could also make the FDA move us along quicker)..
But the question is.. WHAT IF?.. If we get glowing enough recommendations from multiple government run labs (RBLs) due to the data and peer reviews, in addition to our excellent safety profile.. could we find ourselves in the same position?
Recent IPIX News
- Form 8-K - Current report • Edgar (US Regulatory) • 02/01/2024 01:30:25 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 12/05/2023 09:25:58 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 11/20/2023 09:05:44 PM
- Form NT 10-Q - Notification of inability to timely file Form 10-Q or 10-QSB • Edgar (US Regulatory) • 11/15/2023 01:00:19 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2023 08:15:25 PM
- Form 10-K - Annual report [Section 13 and 15(d), not S-K Item 405] • Edgar (US Regulatory) • 09/28/2023 01:00:08 PM
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Fifty 1 Labs, Inc Announces Acquisition of Drago Knives, LLC • CAFI • Jun 18, 2024 8:45 AM
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Fifty 1 Labs, Inc. Announces Major Strategic Advancements and Shareholder Updates • CAFI • Jun 13, 2024 8:45 AM