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Re: A deleted message

Tuesday, 04/13/2021 2:01:31 PM

Tuesday, April 13, 2021 2:01:31 PM

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If Leo did not think the ABSSSI market justifies a Phase 3 trial, why did he spend time and money to run Phase 2b, met with the FDA for guidance, selected a global CRO, and manufactured the amount needed for Phase 3?

...is pleased to inform shareholders that manufacturing, lyophilization and filling of vials is now complete in preparation for the planned Phase 3 trials of Brilacidin for Acute Bacterial Skin and Skin Structure (ABSSSI) infections caused by Gram-positive bacteria. The vials of Brilacidin are now in the inspection and quality control (QC) stage. The Company is preparing for submission the final protocol for the trial per guidance from the U.S. Food and Drug Administration (FDA) received at the end-of-phase 2 meeting.

With the vials being filled, a global Contract Research Organization (CRO) selected, and the final protocol nearing completion, the vast majority of the work has been finished in preparation for the pivotal Phase 3 trials of Brilacidin for ABSSSI. Cellceutix is almost ready to make history by becoming the first new class of antibiotic to enter a Phase 3 clinical trial for ABSSSI in more than two decades.



http://www.ipharminc.com/press-release/2016/11/16/brilacidin-lyophilized-as-cellceutix-prepares-to-bring-first-new-class-of-antibiotic-to-phase-3-trials-in-more-than-20-years

What happened to the history making of becoming the first new class of antibiotic to enter Phase 3 in more than 20 years? According to Leo, this trial is more than just ABSSSI.

Cellceutix plans to use ABSSSI as a gateway to other indications in areas of unmet medical need. This includes, but is not limited to, biofilm-related infections caused by MRSA.



http://www.ipharminc.com/press-release/2016/11/16/cellceutix-provides-update-on-its-phase-3-preparations-for-absssi

As for the market size, Leo thought it was significant enough to post this.

In December 2014, Merck paid $8.4 billion to acquire Cubist, a market leader in antibiotic development. Its main antibiotic, Cubicin (Daptomycin), has generated over $1 billion in annual sales and is an antibiotic that Brilacidin has performed comparably to, both in the literature and in clinical trials, where Brilacidin went head-to-head with it in Phase 2 trials.



http://www.ipharminc.com/new-blog/2016/10/5/signs-of-big-pharma-getting-back-into-the-antibiotics-business-1

All of these are facts. Holding Leo accountable for his past actions/words is not the same as being ignorant or a paid basher.

Anyone that keeps Bringing the ABSSSI no PHIII trial is either ignorant or a paid brasher IMO.






FUD - Fear, uncertainty and doubt, is generally a strategic attempt to influence perception by disseminating negative and dubious or false information.

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