SNUS- this is the Year of the Dog, correct?
This is a company I used to follow some years ago, and only paid attention back to it in the last few months.
It seems that most analysts misperceived the risk with it, and some point to the fact that the trial was conducted in Russia and other European countries as a reason.
Going back to their phase 2 results however, I note that when the PK study was done, they compared a dose of 175mg/m(2) of Tocosol vs a dose of 175mg/m(2)of Paclitaxel.
They estimated that 175mg/m(2) of Tocosol delivered the equivalent of 364mg/m(2) of P; and the results showed more side effects for ToCp.
So in order to have an equivalent dose of 175mg/m(2) of P, and arguably a similar AE profile, they would have needed 84mg/m(2) of ToCp, not 100 as they used in the phase 3.
So in other words they delivered the equivalent of 208mg/m(2) of P, rather than the 175 used in the control arm.
This seems like a childlish equation to miss, but inevitably they were going for greater efficacy, without knowing the AE profile of Paclitaxel when it was tested at various doses, nor wondering why 175 was chosen rather then 200 or 208...
Call dog a dog, but just for guessing fun I'd say they go back into phase 2 in the coming months.
They should change the CEO though..
