!. FDA has not yet found any marketing practice issues which need to be addressed.
2. SEC is now focused exclusively on collusion by shorts and wholeseller which led to intentional overstuffing of Fusilev.
jmho, of course.
BTW, I assume you have been buying and dollar cost averaging in on the Ride UP From $6.92 PPS.
1. FDA on Zev Marketing: I do not recall any notice from SPPI since this came to light. My understanding is that SPPI included statements about Zev only killing cancer cells and not harming healthy cells and that FDA objected as the statements are unproven and probably not quite accurate. My best guess is that SPPI got off with a warning and nothing more. Interestingly, when I was scanning thru all of SPPI's clinical trials a couple months ago I noticed the SAME language in the clinical trial description. My belief is that someone at SPPI copy and pasted the language from the trial to the marketing label. My guess would be that the statements were included in the trial description as layperson descriptions of 'magic bulelts' that targetted therapy like Zev was intended to represent.
2. On SEC. There has been NO word for months. I personally believe that such things are difficult to prove and that it is unlikely that Raj INTENDED to misslead. I also believe that any company liability will be low at the end of it all, but that Raj personally will likely retire soon - I originally though by EOY, although I could also see him waiting till year end conference call in Feb. I simply believe (as I have stated previously) that Raj was responding to questions and stated his analysis of increasing Fus sales based on increasing Dec shipments to distributors. That Raj had been focusing on drug development and acquisition and was not as in tune with sales as he had previously been and thus did not know Jan numbers at that moment in Feb. Although I do find it suspiciously convenient for the shorts that the distributors would order increasing doses of Fusilev in Dec when actual perscriptions were apparently decreasing I believe it was most likely the result of shorts using clinics to game the distributor's demand models rather than collusion. Collusion would leave too many records and be too risky.