Zadaxin will not be approved by the FDA in the US for HBV unless it goes through trials here, which would be expensive and take years. And HBV is not a major disease in the US, and there are other drug candidates (and maybe a vaccine) that have many years' head start over Zadaxin in that regard. Forget about Zadaxin vs HBV in the US--that is not going to be a market for it. Tc
bottom line--either zadaxin works for HBV or it does not--ie, either it works to extent that patients and doctors want it or not. the latter then = $$$, and with it being so damn safe then it would not make sense even the FDA would not approve if doctors/patients wanted it!
thank you for the clarification.
then if zadaxin is marketed so much worldwide re: HBV, then why can't it be so in US??
is it that you can market in japan and china WITHOUT phase 3 being completed?
i aint no scientist....
>>>yes, ok, but the hep B response can't be THAT much greater than the 4% (opposed to 2% with interfweron only) I just read was in Hep B?!
how much greater is the B response?<<<
HBV is an entirely different disease than HCV, and is a lot easier to treat. Zadaxin scored 20% SVR in its phase 3 HBV trial in Japan, which is better than anything currently approved in Japan at the moment. (Because of missing paperwork from when SGP was running the trial, SciClone can't go forward with an NDA in Japan though).
As for melanoma, posters with more science background than I have say the data is very interesting and encouraging, but preliminary. My suggestion is that you go to SciClone's website (and scicloneinternational as well) to get up to speed with what SciClone is attempting to achieve in HBV and cancer. Tc
yes, ok, but the hep B response can't be THAT much greater than the 4% (opposed to 2% with interfweron only) I just read was in Hep B?!
how much greater is the B response?
ALSO, with the melanoma, i read they only are showing 7 to 13% in the arms of trial and i do not think that if those numbers even hold that there is much of a market, RIGHT?
>>>I want to but scln now but HOW IN THE WORLD can zadaxin be SELLING BIG TIME IN CHINA when the FDA will not approve and the phase 3 trials FAILED?????
So the CHINESE are paying for a drug when it helps very little?<<<
The Chinese are using Zadaxin primarily for HBV and cancer; the failed phase 3 was for a different disease--HCV. Tc
I want to but scln now but HOW IN THE WORLD can zadaxin be SELLING BIG TIME IN CHINA when the FDA will not approve and the phase 3 trials FAILED?????
So the CHINESE are paying for a drug when it helps very little?
dude-wounded elbow is here because he's being paid to bring the stock price down. in my opinion he's being paid not by a competitor but by someone who wants to do a complete buy out so that will be good for us in the long run. therefore let wounded elbow run his mouth and eat his dorritos. as long as we hang on i think we will be doing just fine.