We're finally at "mid-December" timeline and so far the market response has been a big yawn. Since Monday is Dec. 12, things will start happening any day now, though for whatever reason Tues-Wed of this week is still my guess for release of hepatitis data. Undoubtedly Roche has seen data by now, could a preemptive deal already be in the works? Were the lights on late at SciClone headquarters? The lack of stock activity speaks against partnering but it's not like there has been major selling either. I was a bit surprised that nobody took out my entire bid at 3.57 yesterday and that tells me that there is more of a "wait and see" attitude by shorts now with no big moves until news release or news leak. I even left a message (phone and email) at IR but--no surprise--no response there. Ira seems like the type of individual who would have a carefully thought out plan as to when and how news gets presented. He has lots of chips to play but we don't know his cards, nor do the shorts. Hep C data and melanoma data clearly are the big news releases. However, progress re SGP, avian flu sales update, pegylation announcement, and big pharm partnership are all possibilities for this month. All bets are off, horses are clearly at the starting gate. We will all have to check emails for early morning announcements this week--easier to do on East coast than West...Wounded remains on ignore mode for me, so message board is a faster read. Good luck to all longs, we've been waiting a long time!
I've wondered what happened with the formulary issue too. Maybe the Mexican officials in charge are waiting to see the trial results before making a decision. The other possibility is that the answer was no and SCLN is waiting for the right time to give us the bad news.
One other thing I forgot to mention in the previous post that might provide some encouragement r.e. the current trials : The dose-ranging study where we got a 30% EVR only enrolled patients with a viral load greater than 2 mill. IU / ml. The first 600 patients in the HALT-C study , which might provide a reasonable comparison to the type of patients we'll have , had 25% of patients with a viral load less than 1.5 mill. IU /ML. There was a big difference in SVR rates between the high vs. low load groups , something like 37% to 15%. So this trial will be the first data we see that treats some low viral load patients with pegifn plus Z (i.e double therapy ). I don't think there is any requirement in the trials for viral load except that they have positive HCV RNA at screening.
It's understandable to have doubts when you look at the little data we have seen so far and combine that with the knowledge that gen 1 nonresponders are a tough nut to crack.
The Mexico triple therapy study had about 60% EVR (as bertha just noted) yet only resulted in about 20% SVR , so only about 1/3 of EVR achieved SVR.
The pegifn plus Z dose-ranging study got a 30% EVR in the dose used in the trials , 1.6 mg. If you assume the same 1/3 conversion to SVR , you get 10%. However , maybe without riba the conversion to SVR would be even lower. And since we got 36% EVR with 3.2 mg. in the same study , why in hell are we using 1.6 ?
That's the pessimistic case.
I have a more positive outlook because I think that management knows a lot more than they've let on , and what they know is good. The mysterious " data on file ".
If you look at early PRs about the trial , they say that dosage was chosen based on clinical and commercial data on file. I think the dose-ranging study was only a formality , and I'd guess they didn't even follow up with full treatment of those patients because they probably would have had to share that data with Roche , which they would have avoided doing.
We don't have much data about the viral kinetics with pegifn plus Z , but what we have indicates that the decline is slower than with pegifn plus riba. 12-week EVR may be a poor indicator for the current trials. It could be that we will get a 1/3 (or more) conversion based on an EVR-type measurement , but one taken at a later time point. So , I think that there is hope for the upside here.
The triple therapy trial could mislead for a couple of reasons. First , the assumption is made that riba adds benefit to Z + pegifn. We don't know that yet. Since Z works largely thru promoting a th1 response (in a natural way ), and riba works at least partly in the same way ( but unnaturally ) , they could be crossing signals. Z is trying to do a professional tune-up on the th1 response while riba is installing mis-matched spark plugs , dumping brake fluid in the radiator , and scattering tools all over the place. Z might do a better job alone , resulting in higher conversions from early response to SVR.
Second , the Mexico triple therapy trial was a worst-case outcome , IMO , because , well , because it was in Mexico. If you apply the necessary correction factor of 1.5 to convert the SVR result from MSU ( Mexican Science Units ) to USSU , you get about 30% SVR. Much better now , right?
BTW, I think that this trial , because of the size , will tell us if there is any post-treatment conversion to SVR as we see in hep B. I'm betting we see a couple , but probably won't hear about it next week.
<<We will all have to check emails for early morning announcements this week--easier to do on East coast than West>>
Not really WCD.....all you really have to do is sleep with your cell phone near you! Hey, I wake up about 5:30 eastern time.....SCLN usually puts news on at 6:30 eastern......so if news is out, good or bad......it will be on the wire at 6:30.which is 3:30 a.m. to yoou.
Just pretend you are back doing your post med school residency work schedulke torture....and you only has a few hours sleep anyway! You want? I'll call ya.....just gimme a generic yahoo email address, and I will write you, you can answer and give me a cell number. HAppy to do it. Up to you. You want to get up at 3:30 if it is good news? Maybe you just want to sleep in if it is not so good.
<<You want? I'll call ya.....just gimme a generic yahoo email address, and I will write you, you can answer and give me a cell number. HAppy to do it. Up to you.>>
That board gets funnier and funnier ( wounded
you can correct my english).
Snogreen is opening a phone call center! He
is already doing a traineship.
Good iedea. So he won't find himself in the trailer park like Terry.
Well, I should pick up that idea. All the time I've been thinking what to do in the case that SCLN ends in a big fiancial fiasco for me.How could I pay back granma's spare money than ..
get the money to buy back all those things I
gave to the local pawnhouse...
A call center - not bad - I see there is life
and I had already seen me in this new
Burger King restaurant flipping Double Whoppers
Thanks Sno, my email address is email@example.com. These days I haven't been sleeping well either, so if I wake up between 3:30 and 5:00 it will be hard to resist checking my email. I am so sick of the waiting and the silence that I hope SCLN just gets it over with soon. What's your guess--a press release followed by a conf call later in the day? A release after market close would scare me, I'm glad there was no Friday announcement. I think they'll release news at their 6:30 Eastern time and then have call in a few hours. Maybe they'll announce Monday that the release will be on Tuesday or something like that. I still can't get over thinking that if news weren't good enough for FDA approval then company would not be releasing it early in December rather than waiting for whole 1000 pts to complete. If there are ANY delays past announced timeline, shorts will kill us. Glad you enjoyed talking with the BTM folks, they're actually very smart and Alan follows SCLN more closely than David it seems. You can be sure they will be posting their analysis very quickly after conf call, sometimes both before and after. It's how they work and their insights are worth listening to. I know they also have faith in Ira. Let's hope he has a good hand to play. I think he does.