The fact is pure and simple, with good or great results the sky is the limit. If we get the needed results, I think FDA approval and at least a partnership is a given. And I reallly believe the results will be good, if not great. The problem lies with this is company is the investment is virtually a zero sum game at this point! If the August results are not what is needed, this company will virtually be worthless.
A big risk for those that don't do DD and after watching ARENA yesterday, I really don't trust the markets at all. I am longer in this than I should be in any speculative stock, but not taking anything for granted! And Radgray below, after the beating I took yesterday, I am with you, but I will be on Zantacs and maybe Xenex until mid August! lol
Take a look at the KERX run last year. KERX was also an "all or nothing" play. I made 52K, but got cold feet when the study results were delayed. The Analyst target was around 4.50, so I sold based on what I thought was limited upside. HOWEVER, when the US results were released, stock tripled in two or three days.
MNKD seems a bit like KERX, although MNKD seems to be priced with a higher bias toward success. I'm now conflicted again as I'm up 160K here and debating to sell or not to sell... or to sell and buy options... or to hedge with puts.
I think Affinity 2 should be a given. What I'm not sure of is Affinity 1. This is the first trial I've ever owned a stock in where the dosage is adjusted during the trial. So long as there are no hypos, it would seem the dosage could be adjusted to ensure at least non-inferiority. Also, I was questioning whether non-inferiority here really means an exact comparison to the control OR if it means that H1ab levels are held below a given threshold just as well as control... so inferiority is measured by how many patients fail to achieve H1ab below the threshold, not how far below the threshold they are.