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BIzzy

09/01/21 9:30 PM

#372800 RE: wsbc #372799

I hope this is not true…I believe in Leo but the size of this trial supports the argument made….
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frenchbroad

09/01/21 11:26 PM

#372822 RE: wsbc #372799

This cancer you speak of bought Brilacidin for $5 million. And now it is your only hope.
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Hugon

09/02/21 12:11 AM

#372832 RE: wsbc #372799

Perfectly summarized…
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Justfactsmam

09/02/21 8:41 AM

#372861 RE: wsbc #372799

Interesting...reading your own post...very consistent with your past ones...


"To date, there are no deals and no BP interest because trials have been inconclusive due to lack of statistically significant size. He knows this and yet has continued to run statistically insignificantly sized trials..."



1. "There are no deals..."
Why should there be BEFORE COVID-19 CLINICAL TRIAL RESULTS? (fabricated expectations) Reading the PR's...IMO LEO's position has always been "It's about the clinical trials" (for COVID)...of course IPIX has a deal with UP and delivery of Phase III CT for UP ...which has been PR's as progressing and waiting while drug to be mfg and delivered.

2. "No BP interest in trials..."
Why should LEO announce and disclose specific interest by BP (LEO HAS ALREADY PR'D THAT BP HAS INTEREST IN SEVERAL INDICATIONS FOR BRILACIDIN)...in fact, NON-DISCLOSURE AGREEMENTS are almost 100% of the time executed before any discussions (totally unsubstantiated ...esp. about Brilacidin and IBD...IPIX already has a B/UP licensing deal, with right of first refusal for IBD, with AF...(and more in IBD ? Humm...) (facts contradict your allegation)

3. "trials have been inconclusive due to lack of statistically significant size."...
FDA will NOT APPROVE A REQUESTED CLINICAL TRIAL unless TRAILS CAN RESULT IN STATISTICALLY SIGNIFICANT OUTCOME and:
A. A COMPANY HAS to have ON HAND their DRUG already mfd TO BE TESTED,
B. They need to SET OUT IN PROTOCOL, the MO of the Trial, including sites selection and consent from those sites to hold trials, and
C. The proposed Trials and THE PROTOCOL (including the NUMBER OF PATIENTS) of the TRIALS and OUTCOME NEEDS TO BE ABLE TO PRODUCE (ACCORDING TO FDA AND SCIENTIFIC STANDARDS...a "STATISTICALLY SIGNIFICANT OUTCOME"...regarding the Primary and Secondary Endpoints of the trial! (YOUR STATEMENT CONTRARY TO FDA PROCEDURE...it could not be approved unless in the VIEW OF THE FDA, the 120 patients could be statistically significant!)

4. "He knows this and yet has continued to run statistically insignificantly sized trials...
LEO and FDA KNOW TRIALS CAN PRODUCE A STATISTICALLY SIGNIFICANT OUTCOME...otherwise, FDA would not have approved the protocol!
(facts contradict your assertions)

ALSO...

Every day that passes ... every day we are CLOSER TO DATA RELEASE AND TOPLINE RESULTS and BOOM!!!

Personal and arbitrary deadlines by some investors are irrelevant...

IMO...EVERYTHING ON SCHEDULE ... and if I were LEO...there would be NO ANNOUNCEMENT OF DATA LOCK...just TOPLINE REPORT WHEN DONE PER PROTOCOL...and likely a day or two longer with 3day vs 5day dosage bification

ALSO...IMO a RUSSIAN DEAL, 1st...is a realistic possibility...esp if any games are attempted to be played by BP, etc...

LEO NEEDS TO HIRE "NO ONE"...except good legal counsel to draft, with Dr. DeGrado's consultation, an ironclad License or IP sale agreement! He has proven he can produce a product and deliver it where ever it needs to go. He is running a tight ship!

BOOM!