I think it is also important to consider what BTD
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Posted On: 05/29/2022 9:01:38 AM
I think it is also important to consider what BTD actually is, it is not an approval or the FDA saying the drug is a “breakthrough”. The application just has to show the trials indicate it is significantly better than other drugs. Note the wording from Wikipedia below:
Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act.[1][2] The FDA's "breakthrough therapy" designation is not intended to imply that a drug is actually a "breakthrough" or that there is high-quality evidence of treatment efficacy for a particular condition;[3][4] rather, it allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.[4][5] The FDA has other mechanisms for expediting the review and approval process for promising drugs, including fast track designation, accelerated approval, and priority review.[4][6]
To me, it seems this aligns with the purpose of a p2 trial. This phase is to form the final p3 trial so all variables that can be tested should be tested so the dosing etc can be part of the protocol in p3 that will get approval. There should be very little discovery in p3, that is for p2. The pooling of data from 3 trials in my opinion is an extension of this to get to a good p3 trial protocol. I think the FDA is likely trying to not give special treatment beyond normal process because they often do and the drug is not actually better. Leronlimab can be put through he normal process and get approved, it is unfortunate that BTD was not given but it is not stopping the process. Cytodyn themselves did not know the scope or scale of leronlimab in oncology, they needed to do the p2 trials to know how to get a good p3 trial protocol.
Breakthrough therapy is a United States Food and Drug Administration designation that expedites drug development that was created by Congress under Section 902 of the 9 July 2012 Food and Drug Administration Safety and Innovation Act.[1][2] The FDA's "breakthrough therapy" designation is not intended to imply that a drug is actually a "breakthrough" or that there is high-quality evidence of treatment efficacy for a particular condition;[3][4] rather, it allows the FDA to grant priority review to drug candidates if preliminary clinical trials indicate that the therapy may offer substantial treatment advantages over existing options for patients with serious or life-threatening diseases.[4][5] The FDA has other mechanisms for expediting the review and approval process for promising drugs, including fast track designation, accelerated approval, and priority review.[4][6]
To me, it seems this aligns with the purpose of a p2 trial. This phase is to form the final p3 trial so all variables that can be tested should be tested so the dosing etc can be part of the protocol in p3 that will get approval. There should be very little discovery in p3, that is for p2. The pooling of data from 3 trials in my opinion is an extension of this to get to a good p3 trial protocol. I think the FDA is likely trying to not give special treatment beyond normal process because they often do and the drug is not actually better. Leronlimab can be put through he normal process and get approved, it is unfortunate that BTD was not given but it is not stopping the process. Cytodyn themselves did not know the scope or scale of leronlimab in oncology, they needed to do the p2 trials to know how to get a good p3 trial protocol.
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