FDA should respond to NDA submission by the end of the month..
I've been in the biotech industry for the past 25 years and have gone through the entire cycle from R&D to full commercialization of block buster drugs. I agree with Proinst. that there is a potential for some delays for GMP issues. The FDA may want a facility modifications or a Quality system change (e.g. better deviation handling procedures). We won’t know until we get there final ruling in May, but the most likely scenario is only a minor delay or approval with promises from OPTR to address the issues with a future filing or in an annual report. The April 5th meet with the FDA will also give ample warning if there are any clinical concerns of the FDA.
I think the bottom line here is that OPTR has a new way to fight C Diff and they will get approval. Also if OPTR management works with the FDA with a compliant attitude it will go a long way to make the approval easier and quicker.
C Diff has been and continues to be such a problem in hospitals this product has great potential for improved health care and great possibilities for investors in OPTR. I wouldn’t bet the farm on it but I’m confident that the approval is coming and coming in May if not no more than a few months after. Go long in OPTR and I believe that you will be rewarded.
Finally some decent input about the risks of potential delays, although, IMO Max is very consesrvative, especially based on FDA recent actions with other antibiotics...
And I have to disagree about the great possiblities for investors in OPTR. The problem is it's current valuatuion of ~ $500Million, which IMO, FIDO and OPTR pipline is writing checks they can not cash (to use as a methaphor) to support this valuation. If this drug has the potential selling over 1Billion or even between $500M-1B, big pharma would have been ALL over OPTR. If it sounds, looks, acts, like a duck, folks guess what?
This might be a good quick short term trade once it gets to a reasonable valaution, but at the current valuation, there is tremendous risk. I might cover should the market cap fall ~$150-200Million....