Acancel, … but it seems that a phase 2 trial
Post# of 153903
(Total Views: 851)
Posted On: 07/29/2020 7:43:02 AM
Re: Acancel802 #45578
Acancel,
Yes, implicitly and explicitly NP has mentioned that hey wanted to have results from both trials concurrently.
This comes back to before the design of the trials which were timed for simultaneous data availability (14 days M-M one month S-C).
There are advantages and disadvantages with doing it this way. However, I believe that NP's tactic is to leave FDA as little wiggle room as possible: you present them with good results in M-M and S-C.
The FDA then has in the front of their faces and MOA and clinical outcomes that can't be challenged (even tough the S-C data is only safety review).
NP's objective is to get emergency approval authorization for Leronlimab in M-M due unmet clinical need (and simultaneously set the stage for a favorable S-C interim analysis in few week's time).
This is our goal at this stage, a difficult one. Not because of Lero's efficacy, because FDA will try to block us at every 5 yard line (pardon my parlance).
Let's hope for stunning results that will get FDA into a difficult-to-avoid decision.
Quote:
… but it seems that a phase 2 trial is meaningless unless backed by a phase 3 especially if phase 3 shows great results with even more severe patients. Its put the FDA and the world on undeniable notice that Leronlimab works without a doubt.
Yes, implicitly and explicitly NP has mentioned that hey wanted to have results from both trials concurrently.
This comes back to before the design of the trials which were timed for simultaneous data availability (14 days M-M one month S-C).
There are advantages and disadvantages with doing it this way. However, I believe that NP's tactic is to leave FDA as little wiggle room as possible: you present them with good results in M-M and S-C.
The FDA then has in the front of their faces and MOA and clinical outcomes that can't be challenged (even tough the S-C data is only safety review).
NP's objective is to get emergency approval authorization for Leronlimab in M-M due unmet clinical need (and simultaneously set the stage for a favorable S-C interim analysis in few week's time).
This is our goal at this stage, a difficult one. Not because of Lero's efficacy, because FDA will try to block us at every 5 yard line (pardon my parlance).
Let's hope for stunning results that will get FDA into a difficult-to-avoid decision.
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