Unfortunately it's seems an exception to find a small biotech CEO with the skill sets, talent - and smarts - to take an manage an opportunity through the process from R&D concept, pre-clinical, clinical trials, FDA approval, sound partnerships and onto the pharmacy shelf. Some are good at "raising cash", hiring the best, hooking partners (no pun intended) etc. Some are great project managers and team leaders and move the ship along, understanding enough of the science to deal effectively with obstacles.
But with that, some are stymied at the NDA (like here) because of inadequate planning and preparation - especially frustrating with a drug that is shown to meet safety and efficacy endpoints. That's what this sounds like. All of the CRL issues are addressable, which is good news. The real bad news is there are CRL issues that must be addressed and followed with a new submittal.
He could. Unless the health inspector came in. I can hear it now, So um I should properly label the slurpie cups? So um we have to have the machines plugged in? So um when I put a sign up saying these are fda approved hot dogs I have to have proper documentation. So um I expect to comply and have the doors open by next year. Please continue to invest.