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Re: Monroe1 post# 226355

Tuesday, 10/24/2023 8:17:21 AM

Tuesday, October 24, 2023 8:17:21 AM

Post# of 233718
From page 29 of the 10Q

As of the date of this
report, the Company has submitted the following to the FDA in connection with resolving the clinical hold: an aggregate analysis of cardiovascular events across all leronlimab clinical programs, a Safety Surveillance Plan, an aggregate safety data analysis, an updated Investigator’s Brochure, annual reports, a benefit-risk assessment, and a general investigational plan. The Company is currently finalizing a supplemental submission to address items discussed with the FDA during the informal meeting.



What the hell is going on? They haven't even submitted a response to the FDA from a meeting they had in MARCH!!! UNACCEPTABLE!! They are not waiting on the FDA for anything. They haven't submitted the response, so this one's not on the FDA being the hold up. How pathetic is this management? 12 people sitting around harvesting exorbitant salaries for what? Now they want all the shareholders to vote to continue the charade. Remember the "new communication strategy"? Another failed objective. They are down to the bare minimum legal requirements of communication. Whoever votes to give them more money based on the past performance and current communication strategy about what is really going on with the hold, deserves to watch the PPS swirl down like a turd in a toilet. 10-1 you find out what is really going with the hold right after they get their additional money. Why don't they all take significantly reduced salaries so they can hire a real CEO and preserve cash until the hold is lifted? Seem reasonable?
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