It was not the FDA’s designation and this was an evaluation of the drug in a system that wants to be one of the best. It was further in a system that is cost conscious, and this company has innovated how to deliver this treatment cost effectively. I think they were looking at a drug they’d like to see available in the UK. Period.
I did not say the designation was about results. They looked at the whole picture and it says, if successful in trial, which it evaluated appeared to be likely, this is a drug we hope to make available.
As for the likelihood of approval, we already know the results of the trial and a reasonable range of likely costs for manufacturing and sales. The current non-scaled costs are likely to come down with scaling and automation. For 2-3 years of treatments, a drug given at the doctors office as a shot, that has few to no side-effects and lets the patients live substantially longer is going to likely compare quite well to traditional drugs given in a hospital with severe side effects that also have to be treated and that compound illness and the feeling of illness.
I think some people’s negative guesstimate on this are likely completely off, and perhaps anyone’s stated involvement in the industry could be a sign of a lack of objectivity.
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