A huge tidbit dropped by SCLN today. And that had to come in and with discussions with teh FDA and what they want out of the trial to get it approved. P Value seems a top priority. The results have to be statistically significant.
Now since Peg Interferon by itself on a re-treatment get's between 0% and 2% response...if the addiotion of Zadaxin merely adds to a 7-10% response....the P value will be hugely in SCLN favor....since Peg Interferon gets almost a 0% response on retreated non responders.
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!
Dont't be too hard on him walk up. He failed to become an M D and is now a DVM (allegedly) relegated to looking down horses mouths (or the other end)on a daily basis...this made him sour.
By the way, windy, non of the large animal surgeons listed on the web site of the Cornell College of Veterinary Medicine live in Cayuga Heights. Visiting??
<<I post FACTS about drug development, etc, to counterbalance the absurdly ignorant posts of the likes of SNOTball, et al.>>
Yeah, it's great to have such a wonderful humanitarian on board trying unselfishly to save us all from ourselves. LOL
By the way, what is the latest strategy now from you, Fernandez, et al regarding trying to even up a 2 million short position in 32 days with the avalanche of news approaching?
There are bids in the pre-market already for $5.00 and no one is selling.
Tick, Tock . . . Tick, Tock . . .
Good morning to you too. Do you eat nails for breakfast? By saying I listened to the c.c and wishing that there was a mention of Kirk and Cavazza holding how does that translate into pom pom swinging? Buddy boy you are bright but your presence on this board doesn't add up. In addition to being bright your voice is almost always nasty. Nastiness usually doesn't result in pursuasion.. Enjoy the rest of your day and see if you can avoid irritating whomever you contact today. Your posts only exude one tone and one thought. Try spicing up your posts with some variety.
Looks like bashers will be back in force today. I listened to conference last night and i was hoping someone brought up Kirk and Cavazzas stake and if the company has had any talks with them about activist roles they might be suggesting.
>>>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
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!
Is it just me or does not everyone see how little comprehension of the most basic concepts Sno shows by a post of this type. To say that the FDA will approve based on a P value is truly one of the most ignorant statements I've ever seen.
Sno here's a clue since you obviously never took statistics even in high school. The P value is a result of the results. FDA looks for results. The P value lets them know the degree to which one can be certain that the results didn't happen by chance.
Instead of popping off about nonsense all the time, why not educate yourself substantively.
<<And that had to come in and with discussions with teh FDA and what they want out of the trial to get it approved.>>
And those "discussions" were almost certainly in regard to the unblinding of the first arm.
The bar just got lowered ridiculously low.
Although you worry that the street will pooh pooh the data, if the message is told professionally by the new PR firm, it has a good chance to be scripted in a way as to get a very good splash!
"The bar just got lowered ridiculously low."
The bar never moved. The FDA approves based on significant clinical benefit- which translates to a p value less than or equal to .05 combined with an acceptable safety profile.
When a researcher indicates a study is "powered" to detect "x" differences-- it means the study is designed (ie, the number of subjects to be enrolled is determined using previous data) to result in a p value less than or equal to .05 when differences of the indicated magnitude "x" are observed.
Sno, we both posted that at the same time. I agree that the comment about P-value is very important, and a MUCH more attainable goal for SciClone. Great call today, I think we see a reaction over next few trading sessions and it is a perfect backdrop for Ira's trip to New York and meeting with some funds with "serious money."