Happy Thanksgiving. Fellow Mods, feel free to delete if you feel the need. I know some other CTSO investors jumped on the CRMD wave about 2 years ago and we made some good short term gains. This is the first biotech I have been invested in that had a study halted early by the DSMB because of efficacy demonstrated at interim analysis. Now the FDA says an AdComm meeting is not needed before the PDUFA date? This is truly unusual. I know they had issues with their CRO a few years ago, but the woman they brought in to follow-up with the data collection seemed to be top-notch. Since PDUFA date is a deadline and not an announcement date, I would love to see some good 2020 news for a change. It is up 40% in 5 days with little online hype that I have been able to find, so I do not think it is a pump and dump situation. Something is up. My guess is early FDA approval, and/or partnership or Buy-Out.
I have seen that the biggest problem in investing in these micro-cap biotechs is that even with FDA approval, if they get it and try to go-it-alone towards commercialization, building out manufacturing, marketing and sales is a loooong, like years long, process. ACRX is a good example of this, but ACRX also has the hurdle of a paradigm shift. The jump from IV to sublingual pain killers, in emergency and out-patient surgery, is not a small one.
CRMD, however, is simply a swap out of an existing product for a much better one at a comparable price. The latest CRMD PR also states: "We look forward to completion of the review of the NDA and are considering all strategic options to be able to successfully bring Defencath to the U.S. market as soon as possible." In my opinion, partnering up or a buyout takes the "long" part out of the commercialization process. This could get exciting, but if it ends up with the go-it-alone route, I bet there will be a sell-off. I'm still waiting on the Crystal Ball I ordered from Amazon. This investing thing should be much easier once it arrives.
