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
TC, I can understand your point, just as I do WCD. Instead of arguing about what is the best scenario for Zadaxin approved by the FDA, let's argue about getting this drug approved by the FDA (PERIOD). Today's conference call was extremely positive, as was Ira's statement that he would view as very positive single digit improvement in efficacy of Zadaxin with Pegyasis in treating Hep C over current treatments.
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.
WCD, my only point is that I felt more positive by the comment from Ira about single digit efficacy. Given the large number of studies regarding the use of Zadaxin, Peg-interferon, and ribavarin (copegasus) in triple combination and the effectiveness of this combo I absolutely understand that ultimately Zadaxin would be used and most effective in such a combo. If Ira feels that single digit improvements would be acceptable for Zadaxin in the Hep C trial why should I not believe him given his experience in bringing drugs through the FDA approval process. His remarks were very positive to me. What would you think if Ira had said a single digit effectivenss was totally worthless in applying for FDA approval? Well, you would probably be saying that let's wait and see what the results are with interferon, ribavarin and Zadaxin as the stock price collapsed to 2.00. I believe that if the company can get Zadaxin approved for Hep C, or any other major indication, that the off label use for Zadaxin will be as great or greater than for what the drug was originally approved for by the FDA.
I am positively influenced by Ira and his management of SCLN over the past five months, which is a very brief period. I believe that there is a strategic plan for having the results of Hep C, Phase III, 1st leg, preliminary melanoma results from Phase II trial in Europe, settlement of mediation with SGP Japan, carcinoma results, and results of the pegylation of Zadaxin by the end of the year. Logic says that you would not plan on doing this if you thought that the news, information, results, were gong to be negative for the company. A normal CEO being would not do that. WCD, you have continually said over the past few months, that you are expectant that these public releases of information will be good news and good for the stock price. I am simply trying to give you, and other longs on this board, logical reasons as to why I believe you are right.