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Thursday, February 27, 2020 10:04:16 AM
The progress this company has made is actually quite remarkable. Raising $230M and approaching FDA approval for HIV Combo in 2020 is nothing to turn your nose at. As you know the average cost to take a drug through the FDA approval process is 10 years and $1B. I’d say Nader has navigated this process a whole lot better than you suggest.
The BLA delays are part of the current process and landscape to insure FDA acceptance. The company has wisely chosen a more thorough approach rather than risk submitting an incomplete application that would be rejected. Amarex is assembling Part ll of the BLA and it’s what they do. The FDA requested Mono data on an additional 500 patients and that has required additional time and $. This is not at fault because of company incompetence it’s just part of the BLA process. That’s called being on the same page with the FDA. In the big picture its a positive as it demonstrates the FDA’s interest in the efficacy and safety of an increased dosage as a mono therapy. This is a stepping stone for expanding the HIV Combo Label once approved.
You pick at the 82+ PR’s. It’s clear this bothers you because they reinforce the safety and efficacy Leronlimab consistently demonstrates in both HIV and Cancer. The truth is this molecule is demonstrating groundbreaking results in the metastasis of cancerous tumors. Reducing CTC to zero and shrinking tumors after three weekly injections at the lowest 350ml dose is impressive-period. Let’s see what happens as the dosage is increased to 525ml and then to 700ml. I like our odds going forward based on the results of the first five patients dosed with 350ml.
The current basket trial is going to reveal the effectiveness of Leronlimab in a very short period of time. With 85 patients waiting on deck the data is going to start stacking up. The outcome will be what it will be. Up to this point the data is very compelling. If you think 82+ PR’s is overkill get over it because they are going to keep coming. You can continue to pound your negative surface story while the company will continue to update the world on the progress of Leronlimab.
Much to your dismay the funding will continue to flow via the converting of warrants and minuscule dilution until a licensing deal that benefits SH’s is consummated. None of the investors here that understand the complete story are concerned with the dilution card you are pushing.
This is not smoke and mirrors and some junk company you banter about. This is about real science with an army of investors that understand the validity of the science and the landscape that must be navigated. Not the other way around.
Regardless of the short term SP the vast majority will be here for the final chapter and you will be long gone. We like our chances and are not biting on your redundant surface story.
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