Q: Hi 5i team,
This is a further question on healthcare and their binary outcomes on drug trials and approvals. I did buy MDT by the way based on its growth prospects and little or no dependence on drug approvals. This question is on AMRN and more generally the FDA approval process. AMRN has an upcoming date with the FDA on November 14th. From a business site, I quote “The Adcom review of the sNDA for Vascepa on its cardioprotective benefit is scheduled for November 14, 2019 with PDUFA planned for December 28, 2019”. What does that mean and how does one go about handicapping the odds of FDA approval or not? If this is largely a coin flip, then I will pass. If it is a progression towards likely approval, I may take a small position. I also understand that AMRN will be subject to a trading halt on Thursday while the review process is underway.
Thanks again for your insight into AMRN and the FDA approval process.
Dave
P.S. I notice that NXTC is down over 50% in the pre-market, a stock you mentioned in the FP for its crazy run last week. I thought tech stocks were volatile. They trade like utilities compared to drug stocks!
This is a further question on healthcare and their binary outcomes on drug trials and approvals. I did buy MDT by the way based on its growth prospects and little or no dependence on drug approvals. This question is on AMRN and more generally the FDA approval process. AMRN has an upcoming date with the FDA on November 14th. From a business site, I quote “The Adcom review of the sNDA for Vascepa on its cardioprotective benefit is scheduled for November 14, 2019 with PDUFA planned for December 28, 2019”. What does that mean and how does one go about handicapping the odds of FDA approval or not? If this is largely a coin flip, then I will pass. If it is a progression towards likely approval, I may take a small position. I also understand that AMRN will be subject to a trading halt on Thursday while the review process is underway.
Thanks again for your insight into AMRN and the FDA approval process.
Dave
P.S. I notice that NXTC is down over 50% in the pre-market, a stock you mentioned in the FP for its crazy run last week. I thought tech stocks were volatile. They trade like utilities compared to drug stocks!