They would not have burned the cash this past year
if they did not think they had a great chance of getting SFP approved and taking it too market. They were already grossing 50M and now plus their new contract for Calcitrol. Why continue down a path spending that much money if it wasn't a sure bet? It would be corporate suicide.
I am long rmti, and have been for years. frankly, it is a poorly managed company, re communications to shareholders and the market, cash management, and management of expectations. It has been a mistake to date, and it appears to me the market will ho hum even positive P3 results, and crucify the stock if the results are less that robust.
Sorry Fridge, that logic does not follow. Depending on the application of the drug, PIII trials which demonstrated good efficacy in PII trials still fail at a rate that exceeds 50% (some disciplines are much higher than others). Among those that fail, nearly 70% are attributed to lack of efficacy...even after strong preliminary PII efficacy data. Without looking at all the data, it is becomes a point of contention as to whether or not the design of the SFP PII trial was sufficiently robust to eliminate efficacy as an issue for rejection in PIII. My point is that no company goes into PIII testing under the proviso that the drug has little to no ability to pass; yet over 50% still fail and the vast majority of those fail on efficacy issues. So your logic, "Why continue down a path spending that much money if it wasn't a sure bet? It would be corporate suicide..." is not supported by the collective PIII data (I believe 2007-2011). Given the equivocal approach to the SFP PII trial, this could weight more heavily on the SFP PIII data to follow. This is what Yocum was trying to say.
I (as well as others on this board) owned Keryx during the perifosine days. The data was examined by a collection of bean counters and statisticians and experts on the board who nothing short of guaranteed the success of the PIII trial, until it failed. The Company, Keryx, bailed on the drug which was picked up by AEZS (a previous partner of Keryx) who chose not to heed the data from the previous trial and pursued another PIII trial with perifosine. I guess that one was a lock, a sure bet as well...until it failed too. I hope you are getting the picture I am painting here. SFP, like all pharma is a risk...a risk that is much higher than most. Accept that and proceed accordingly. But do not use failed logic to support owning the stock. Accept the fact that the drug statistically has greater than 50% probability of falling flat on its face. I for one am willing to accept that risk. Are you?
"Accept the fact that the drug statistically has greater than 50% probability of falling flat on its face."
You can increase those odds against the company based on Yocum's comments and based on them having received a no agreement letter to begin with. Who was it that said they chose the route they went because of financial reasons and not possibly the best course for scientific efficacy?