Hello all, I live near the location and I worked for Merck for a few years. I can't say anymore but that IMO this drug will be green lighted by July 4th. I also see a potential buyout and I think they are currently in talks now with a few companies.
This is a great buying opportunity. Full disclosure as I bought a few weeks ago at $1.86.
I too live near their corporate office behind Houlihan's. I have also played against some Merck employees in an adult sports league. I beleive it will get approved, but not until they submit their "Formal written Response" by the end of June, as stated by DSCO. BMY had an offer on the table a few years back. I would not want a buyout for $5 but would welcome a buyout at $10+. The bigger question is whether Cappy would agree to a buyout... My guess is approval 45-60 days from date of "Formal Written Reponse" to the FDA, which is currently projected to be end of June.
There is little to no chance, imho, getting approval by July 4.
DSO meets with FDA on June 18, and says they will be able to submit their formal response by the end of June. Figure they will submit on/around June 27/30. The FDA then has, I believe, 15 days to determine if it is going to be a class I or II review. Knowing the FDA doesn't do anything early, at least when it comes to small bio's, that decision should come down at/around July 11/14. Best case scenario is that the FDA deems it Class I review at that time, and gives their decision 45 days later, that would take us out to the end of August.
I'm actually hopefull that the FDA won't take the full 60 days and can come to a decision in 30 days after DSCO submits their response. Personally, I expect Surfaxin to be approved any time in August.
Having said that, I don't think I live anywhere near any Merck employees, let alone play sports with any of them.