$RLFTF Quote: you are quoting data on 27 patients
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Posted On: 08/21/2020 6:30:40 AM
$RLFTF Quote:
you are quoting data on 27 patients ...encouraging yes ...but you can not extrapolate that out and say the next 27 will have the same results ...Thats why we run double blinded placebo controlled trial
You need to read up on powering trials and the importance of the P value .
The report showed improvement with statistical significance in both patients on ventilators and ECMO. And the chairman said in an interview last month that the compassionate access program alone could result in FDA approval.
https://themarket.ch/interview/relief-therape...ar-ld.2478
"Together with its partner NeuroRx, Relief is currently conducting several studies in Israel and the US on Aviptadil for the treatment of Covid-19 patients. Are these studies relevant for approval?
"Let’s focus on the US: That is a Phase IIb/III trial that is aimed at patients who are severely ill because of the consequences of Covid-19. Assuming we have positive, statistically significant data, we would be in a position to go to the FDA and ask for approval. There is also a potential way to get approval sooner: This is by presenting the FDA clear evidence that the drug is therapeutically meaningful effective in a so-called compassionate access program. Having been granted the permission by the FDA to conduct such a compassionate access program, we are currently in this program. The study we are running has registrational quality. If it would be successful it could be the basis for a FDA approval. "
They may not even need confirmation from a double-blinded trial. Certainly no one would expect them to do that with patients in this critical condition. But they do also have the interim analysis for the IV trial coming up which can provide further support.
you are quoting data on 27 patients ...encouraging yes ...but you can not extrapolate that out and say the next 27 will have the same results ...Thats why we run double blinded placebo controlled trial
You need to read up on powering trials and the importance of the P value .
The report showed improvement with statistical significance in both patients on ventilators and ECMO. And the chairman said in an interview last month that the compassionate access program alone could result in FDA approval.
https://themarket.ch/interview/relief-therape...ar-ld.2478
"Together with its partner NeuroRx, Relief is currently conducting several studies in Israel and the US on Aviptadil for the treatment of Covid-19 patients. Are these studies relevant for approval?
"Let’s focus on the US: That is a Phase IIb/III trial that is aimed at patients who are severely ill because of the consequences of Covid-19. Assuming we have positive, statistically significant data, we would be in a position to go to the FDA and ask for approval. There is also a potential way to get approval sooner: This is by presenting the FDA clear evidence that the drug is therapeutically meaningful effective in a so-called compassionate access program. Having been granted the permission by the FDA to conduct such a compassionate access program, we are currently in this program. The study we are running has registrational quality. If it would be successful it could be the basis for a FDA approval. "
They may not even need confirmation from a double-blinded trial. Certainly no one would expect them to do that with patients in this critical condition. But they do also have the interim analysis for the IV trial coming up which can provide further support.
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