The purpose of a Break Through Designation isn't t
Post# of 154001
(Total Views: 546)
Posted On: 01/06/2022 6:05:08 PM
Re: Evil Rabbit #114043
The purpose of a Break Through Designation isn't to boost a company's stock price or be a feather in a company's cap but to give a company special treatment in their attempt to get approval for a promising drug and to get it into use faster. It means real help!
It does matter if we get the designation but if we still get some special treatment from the FDA, I would be OK with that. We may get it as the FDA sees in all our trials an outstanding safety profile. We should get a BTD just on the safety alone, of course!
Trodelvy is still just a clunky chemotherapy with all the adverse effects and organ toxicities. It probably can't be used by those with an impaired liver, kidneys or other vulnerabilities. Leronlimab can.
Our MOA is nothing like Trodelvy's MOA. Leronlimab, being an immunotherapy drug, should get a BTD. But if it doesn't, all I want is some of the special treatment that would come with a BTD.
So, first, I would like the FDA to not make us wait 60 days for a comment on our updated survival metrics and, second, to allow us an immediate start on Phase 3 trials.
Sure I would like the stock price boost but it probably wouldn't last. Measures that would expedite Leronlimab's approval for mTNBC would probably boost it more.
It does matter if we get the designation but if we still get some special treatment from the FDA, I would be OK with that. We may get it as the FDA sees in all our trials an outstanding safety profile. We should get a BTD just on the safety alone, of course!
Trodelvy is still just a clunky chemotherapy with all the adverse effects and organ toxicities. It probably can't be used by those with an impaired liver, kidneys or other vulnerabilities. Leronlimab can.
Our MOA is nothing like Trodelvy's MOA. Leronlimab, being an immunotherapy drug, should get a BTD. But if it doesn't, all I want is some of the special treatment that would come with a BTD.
So, first, I would like the FDA to not make us wait 60 days for a comment on our updated survival metrics and, second, to allow us an immediate start on Phase 3 trials.
Sure I would like the stock price boost but it probably wouldn't last. Measures that would expedite Leronlimab's approval for mTNBC would probably boost it more.
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