The Street and Cramer should be really embarrassed! This is some of what Falsestein had to say after losing his readers/followers millions of dollars:
"How did I get Sarepta wrong? Without a doubt, I have been a Sarepta supporter and a believer in eteplirsen. My biggest mistake: Having more confidence in the tiny, 12-patient eteplirsen phase II study than I should have.
In my defense, I was clear about the higher regulatory risk facing Sarepta following the failure of GlaxoSmithKline (GSK_) and Prosensa's (RNA_) drisapersen phase III study. What I didn't anticipate was FDA "rejecting" eteplirsen before the drug was even filed.
My worst-case scenario was Sarepta filing eteplirsen based on the phase II study, FDA reviewing the application but then rejecting the drug with a request for a confirmatory phase III study. I didn't anticipate FDA not allowing the early filing to happen at all. Tuesday's scenario was not something I thought would happen. Big mistake.
I also allowed emotion and anecdotal evidence of eteplirsen's efficacy to cloud my judgment. I usually admonish investors for investing in a drug stock based on a personal story. I violated my own rule with Sarepta. "
Hi H,, I haven't been on the board much lately, but catching up there are several items I would like to bring to the attention of those here familiar with arikace but not so much with the "old" Insmed products. One of those items is that once Shire or someone else begins producing iPLEX once again there WILL BE a second MMD clinical trial. The degree of Insmeds participation depends on where they stand with their arikace program, but at this point I would have to believe that Insmed will only be a licensee - which is just fine since the trial will be very costly with success being worth billions!! Outside of cancer, MMD and ALS remain two of the Holy Grails of medicine.