>>>Zadaxon CAN beat a 0.05 P value! I think we will beat that number in a huge way. If that is what teh FDA wants we can do it..but I doubt Zadaxin will get above a 10% response compared to 0%-2% in Peg Ifn alone. Wall Street WILL NOT understand that and poo poo it...but SCLN and FDA will look for P Values for approval....since non responders GEnotype 1 HCV high viral load such an UNMENT NEED. every few percent counts with 2.8 million in U.S. with HCV! P value......yeah......pegasys mono re treatment.....0%-2% SVR! yeah!<<<
I agree that Zadaxin is likely to meet or beat p > .05, and that, since there is no side effect profile worth mentioning, Zadaxin would be approved for HCV. But the biggest negative thing I heard in the CC was Ira's enthusiasm that an SVR in the "high single digits" would achieve statistical significance. We were talking about 15-20% on the board before (and after) the Mexican triple therapy study, after all.
My question--which I don't suppose anyone here is able to answer--it at what point it would become economically advantageous for HMOs to add Zadaxin to its HCV approved treatment regimen. 10% SVR? 15%? I don't know if Wall Street will or will not "get it" initially that 12% or whatever is a good #; though I hope it does: a higher stock price does give SCLN better leverage when it bargains with a partner, that part is fairly important. I do, however, care if HMOs "get it," since that's where the majority of US sales would come from for HCV. And sales (actual and anticipated) are eventually what will matter most. Tc
<<But the biggest negative thing I heard in the CC was Ira's enthusiasm that an SVR in the "high single digits" would achieve statistical significance. We were talking about 15-20% on the board before (and after) the Mexican triple therapy study, after all.>>
I just started reading messages this morning and picked this one to start. All I can say is "there you go again, TC".
Technicium, I viewed Ira'a statememt that single digits would work as a very, very positive statistic for this company and its stockholders, which translates to me to a good stock price and approval by the FDA. Why would anyone that has held this stock for five years, such as you and I have, view as a negative that single digits will get FDA approval? Pense
>>>Why would anyone that has held this stock for five years, such as you and I have, view as a negative that single digits will get FDA approval?<<<
FDA approval is a necessary prerequisite to US sales, but approval will not necessarily result in those sales. And sales, as I said, are the ultimate goal. HMOs will do what's financially best for them. Treating HCV patients isn't cheap, but neither is Zadaxin. I would be much happier with a 15% SVR that was p.04 than I would with an 8% SVR that was p.001 because imo HMOs would be more likely to add Zadaxin to their lists of approved treatments if it cured 15% vs 8%--because this would be more likely to save the HMOs $ in the long run. Tc
Pense, I think the statement made by Al Rudolph or Ira Lawrence that the company would view a high single-digit SVR as favorable compared with control if it achieved statistical significance can be viewed both ways. First of all, they were not the ones who selected "high single digits," it was the posed question. I have had a concern for a while that we may achieve stat significance but if absolute numbers are low (like in my hypothetical example where control group is zero), we may still have trouble both with FDA and achieving sales. That is a big reason why triple-therapy trial in Europe is so important. The SVR will be a lot higher and will make Z easier to market if approved. It does concern me a little when Al Rudolph says it would be great if we're in just the high single digits for SVR. I'd like to see at least a double-digit number to take to FDA. Still, my fundamental optimism re SciClone is unchanged and I view or valuation as a true bargain in a field of many biotech stocks that are still overvalued.
I am hoping for great numbers as well Tc, but maybe it's that trials are so unpredictable, with recruiting patients with so many exclusion possibilities and then there are the dropouts, and tough to get numbers from the cirrhosis trial arm, which might be the one they are more worried about?
Anyway, while we hope for the best, guess we will take whatever we can in order to obtain approval, and usage for other indications as well!