Replies to post #24204 on Relief Therapeutics Holding AG (RLFTF)

[smm886]

102 patients marks the threshold for INTERIM DATA analysis by the data monitoring committee (not FDA approval)

Test *may* need 144 total people if the data monitoring committee doesn't feel the data from the 102 interim patients is enough to submit to FDA for full use approval.

In lehman's terms, this 102 patient is just a look in to whether or not the drug will be safe AND effective enough to justify using it on people who have no exhausted all other options (currently, the EUA is only for use on people who have exhausted all other treatments aka "the worst of the worst")

[meirluc]

You are not missing anything JTORENCE. If 144 patients were needed to evaluate the efficacy of RLF-100, many additional months would be needed for the adequate determination of the peptide's efficacy and in that case Dr. Javitt's statement that we would know within 28 days from now whether or not the trial is likely to be successful, would make no sense. Javitt's 28 days from now absolutely makes sense since the 102nd patient was enrolled today and will be followed for 28 days whereas all the earlier enrolled post 28 day survivors, will have been adequately evaluated for 28(+) days.

The fact that Javitt said that within 28 days from now we will get an idea of the adequacy of the drug, suggests that he believes that results obtained from the 102 patients already recruited will be sufficient for that purpose. By that time, more than 102 patients would have been enrolled and if additional results have to be evaluated, the trial time will be extended.

In summary, I believe that Dr. Javitt is very optimistic and believes that RLF-100 will be adequately evaluated well before all 144 patients have been followed for a minimum of 28 days.