1) Early data obviously has some of the top Heart Failure researchers and National Institute of Health interest in AIR001. 2) US - only Market potential is $1-6 Billion with a company that has only a $65 million market cap. The price is WAY out of whack with the norms for such a company with a serious Phase II trial with this treatment ALONE! 3) NOW we know what the dilution was for earlier! 4) Company is awaiting to place another trial in Stroke, 5) Company is yet awaiting data from yet another drug (sickle cell disease) in Phase III set-to report by the end of the quarter, but if that fails, which I do not believe it will, the upside on AIROO1 alone is huge...Thus, the bottom is negligible in my opinion. 6) If Sickle cell product hits its primary objectives, I cannot see this being less than many of the predictions on this board. Again, the benefit to risk scenario appears to be very much in favor. Please, keep patients in mind with these serious diseases when discussing and of course, know the existing risks with research.
Example follows: If we were using "instant" separation of KM curves in human trials to determine a drug's activity in cancer, we would not be utilizing many of our chemotherapy agents. For instance, it takes 18 - 24 MONTHS, before any separation is recognized in some breast cancer types after initiation of treatment. Many of these agents have very short half- lives (hours) and are provided over a schedule of 4-8 months. Thus, the excuse provided by AF's friend is too simplistic without supporting data. Unlike others, I am hoping results are positive and these patients get some relief!
I won't rehash points as Lobster is correct. However, I would point out that not every product gains this designation as many "me-too" products miss out. Also, discussion of some outcomes & prevalence/provenance data gets reviewed when making such a decision. In this age of biotechs, we are seeing a number of these designations reach fruition though as the treatments tend to be unique and potentially beneficial. So, imo, the way to look at a Fast-Track status provision is - the FDA considers the treatment potentially rendered by the product as potentially beneficial and unique. I have the exact wording somewhere