i asked about the FDA, but they were pretty tight lipped as you can imagine. my goal was to have AVNR to clear up some misconceptions that are floating around out there. have a good weekend everyone.
here are the questions i asked.
1- How do you think the FDA will classify the deaths reported in the STAR trial? Do you anticipate them interpreting them in a similar way to your committee?
2- Follow-up to #1. Can you give an explanation for the difference in mortality rates seen between groups?
3- Any comment on the higher incidents of SAE related to study drug and higher discontinuation due to AE in 20/10 group relative to both 30/10 and placebo group?
4- Can you address how the current response to the CRL answers this question? "FDA has expressed concerns regarding side effects associated with dextromethorphan, including respiratory depression, nausea and dizziness, in the PBA/IEED patient population, which may be particularly susceptible to these side effects"
5- Can you address any concerns with the QTc data? From your recent 10K, you said "we recently completed additional pre-clinical and clinical cardiac safety studies designed to enhance our response to the FDA’s approvable letter and to support planned label discussions with the FDA. Although we believe these studies showed an improvement in the margin of cardiac safety with the new lower dose of quinidine, it did show QTc prolongation of a duration that is above the FDA’s threshold of concern (5 ms mean increase) in approving new drugs."
6- Do you have any comment on why(in the subset of MS patients) missed on some very important endpoints? Specifically the primary endpoint of the trial was missed with the MS data in the 20/10 dose missed and the secondary endpoint of the CNS-LS score improving was missed in both dosing groups?
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