These numbers are not adjusted for the patient cap increase (last week PR) from 100 to 275, as well. None of them are.
This is PRECISELY why the LPCN is so valuable. The safety issue is directly related to the gel. There is no safe pill alternative, available, to date.
This will be a 90-120 day NDA resubmittal with proper algorithmic titration labeling. Meeting with FDA, is tentative, in the next 29 days to solidify timeline. No safety or efficacy concerns means, virtually, zero probability of necessary additional testing data.
Not going to do your work your you. The quickest I have seen was just shy of 30 days and several that were around 90 days. Average is 6 months - 1yr. 2 years if a study needs to be redone. With, LPCN, since it was a labeling issue related to the algorithmic titration a second NDA submission will occur within 1 year. There will be a meeting with the FDA to review and schedule the NDA in the next 29 days.
Yoenis, what happened to your bat? The mets offense is terrible. Noah, is your elbow alright, why is your velocity and control so poor this year?
Correct, current market capitalization is $386m 48.55m shares outstanding. With no money, previously and one product, year-aways, just starting a PII, mathematically, the floor is $2.05pps with years to bleed down.