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I do not think Boger meant on an ITT basis given the various reasons folks fall out. Looking through the general info, it looks like 85% on ITT basis is next to impossible to achieve just because of under-enrollment and misc dropouts (non-compliance?). Also, he could be counting slow responders who get there by 12 weeks but in the latest trial will likely not count.
Jon
Actual proceeds are really the 60 MM less about 10 MM for the warrant value (5 year warrants probably worth 4-5 per warrant but I do not see details on strike price and I don't have my B-S application on this computer) divided by 10.8. This yields about 4.63.
Jon
SGP:
SGP:
Any of the people who follow the HCV space know if the info that SGP was doing in vitro studies combining Bocepevir with polymerase inhibitors has been previously released?
IDIX had hinted at it a while back if memory serves.
Jon
No one seems to know. I have read all of the pre-reports and all of the analysts are guessing, and differently. They all hope for data on dropouts/side effects more than they seem to care about the SVR12 or other efficacy metrics from the overall Prove trials.
Jon
I saw a hypothetical derivation where the 20 became 18-19 due to under-accrual, the 18-19 became 17 or so due to not achieving viral response at 4 weeks and being randomized to one of the other treatment arms, the 17 became 15 due to side effects, and the 15 became 13-14 due to other discontinuations (could be believed lack of efficacy or it worked so well they wanted out of the side effects). According to the Bernstein report, the market is then expecting 6-8 undetectables, yielding an ITT SVR of 30-40% and an SVR of completers of 45-55%. I think the numbers in the IHub surver look too high for either measure, but especially (clearly) on an ITT basis. Remember, these are people with only 12 weeks of treatment so significantly shorter protocol than SOC. Also, some of the non undetectables may become undetectables in one of the other arms.
But apparently even this presentation could be muddied. The 12 week responders could include just those who completed the 12 weeks and had the RVR at 4 weeks , it could also include slow responders who got a response only at 12 weeks (but not at 4 - unlikely though as they will still be in treatment in 1 of other 2 treatment arms), or it could also include those who discontinued and went over to SOC and either responded (or continued to respond - again, though, these folks will still be being treated so SVR12 unlikely to be reported). So, a variety of presentation of numbers is possible.
Jon
DNDN: Good timing on your call!
Jn
That survey was BEFORE the panel if memory serves me - wasn't it?
Jon
LPs do not have liability in hedge fund collapses unless they somehow did something to bring liability onto themselves. That is one of the reasons for the LP structure.
Jon
Not that aspartame is all that healthy for you - go read some of the sites; it is poisoning you.
Jon
If they think now is a good time to diversify their own holdings and "de-risk" things, shouldn't they think the same for the company in terms of funding and de-risking?
Jon
Is this a signal for a quick fundraise perhaps?
Jon
This news increases odds of no call option exercise for GSK as the milestones now go from THRX to GSK since the compound is GSK's.
Jon
That's nice - finish the layoffs on tax day (actually not this year)!
JOn
DNDN:
UBS out saying target is still $3 and approval will not happen until current trial completed. They did think stock would double today perhaps.
Jon
DNDN: The boarders over at IVillage and here on IHUB would say no - it lets the shorts off too easy. But seems simple decision to me.
Jon
I thought the survey would be opening price. Thoughts anyone? I think $9-10. I have seen ranges from $7-20+.
Jon
I continue to believe that TRMS and PANC probably belong together, just hopefully not deep down below!
Jon
The CEO is by his nature usually a salesman (whether officially or not) while the CFO was a crusty old banker - we know what they are like! Cynical, always saying no!
Jon
Here is a summary of the analysts on EASL/other matters (I really wish we could use bullets here):
Citigroup
Still at Hold with $12 target
No interaction data as only 1/3 had completed 36 days of treatment as of submission date - decision made with Novartis to wait for full study results
Data to FDA end of May and public in June
2 discontinuations - GI/nausea and one related to Peg Interferon concentration levels (?)
MY TWO CENTS - Maybe market is perceiving that lack of publishing data means it showed something? Apparently data is still blinded however!!
Morgan Joseph
EASL will have 4 NM283 and 9 Tyzeka presentation
Data remains blinded until end (12 week protocol)
Last patient in mid-Feb would indicate early/mid-May completion
MJ wishes change in plan had not been eleventh hour while recognizing the new plan makes more sense
MJ points out data is blinded so no real information content in delay
NM283 with Peg looked solid with 68% (Taqman) clearance at week 36 (same as 24) versus SOC 53% clearance at Week 24. 48 week data due at EASL. They note the abstract implies viral suppression continued with good tolerability and without viral breakthrough (wasn't this the worry?)
Maxim
Interaction delayed. Delay has NO bearing on outcome but stock will come under pressure as the surprise could be viewed negatively.
PK/PD data from 36 days will be available late May/June (finishes by late March) due to data analysis work - same timing as 12 week data. Question for board: What is the significance of the 12 week data given the specification of 36-day PK/PD effects in the trial? Clearly, it may help decide how to proceed (triple therapy or double without Riba or something else), but it would seem one could deduce further interaction effects out that far given movements in results from Day 36 to Week 12.
In a separate report, Maxim liked the early pre-clinical profiles on the two HIV drugs.
Potential negative/neutral news tomorrow: Info on approval process of DDMAC marketing materials for Tyzeka
Positives:
Positive potential profiles of 12899/12989 vs. Sustiva on resistance and on inhibition of P450 (may need no booster) and on once a day potential dosing
Had expected no negative interaction effect of NM283/Riba (Now delayed of course)
Net net:
In front of multiple valuation catalysts
HBV is worth $7.70 with cash at $3.20 at end of 2006
HCV and HIV come for free
Catalysts include NM283 into Ph III, proof of concept for second generation HCV candidate (expect 3-4 log reduction solo) , and HIV news flow (expect proof of concept IB/II results by end of year).
Expect China approval for Tyzeka in 1H.
Jon
Abstract leak?
Jon
I saw a private company presentation recently which showed three different versions of Hepsera as approved, two with patent protection (GSK version and one of the private company's versions). Sort of branded generic pricing adjusted for Chinese market (as I discussed with some of the bio guys).
Jon
She made the numbers up in the scenarios - pulled them out of her rear IMHO.
Jon
After talking with FDA shortly, hoping to go back into Ph II with liquid dose while working on new tablet/gel formulations. Would then do a small bioequivalency study to move forward. Seems like a reasonable plan to me - thoughts?
Jon
Now he introduces legislation for generic biopharma drugs. Looks like he comes down squarely on the side of cheaper drugs regardless of whether it violates intellectual property rights or not.
Any reason biopharma patents should go longer than pharma patents?
Jon
I think he said he had a job opp there.
Jon
I only remember it because it ranks high in my list of entertaining conference calls:
Thanks - you remembered it for the same reason I did. It was hilarious.
Jon
Didn't Cyberonics get an appeal that worked? From my foggy brain - so could be wrong.
Jon
If the FDA saw a serious—perhaps life-threatening—problem in a combination trial, they could place a clinical hold on all VX-950 development until they sorted it out. Is this a risk VRTX will be willing to take?
I assume this is called the Elan Scenario.
Jon
ETrade will not tell you the percentages but I just played with system and my margin buying power dropped $20,000 with a 1,000 share order (limit $12 to ensure no stupid execution). The buying power is calced based on 30% margin so a drop of $20K (vs. $12K implied in buying power) means their margin is 167% of standard, or 50%, which foots with other changes in account health. There may be something quirky going on given low buying power in the account (cash is off elsewhere doing other things) but this should be close.
Jon
But they aren't even applying Sarbox effectively - look at all of these company restatements and the option scandal. No one seems to be being criminally prosecuted under Sarbox as a result.
Jon
Thanks go seek.
EDIT - I saw Dew's note so I assume the settlement on Hep C was never entered (even though signed?).
Comments on Settlement:
Wow - because he did commercial work during a paid sabbatical (probably made what, $150K) and did a few years unpaid leave (read: NO compensation), UAB got $2 MM upfront PLUS a million if anything comes of the patents in terms of approved drug PLUS 0.5% of revenues. I am sure he had an employment contract assigning all discoveries to UAB but his option to go back to UAB cost IDIX the above - chalk it up to start-up costs.
Now, since Tyzeka is approved, I wonder it UAB is holding out for more or if the settlement will be similar. If similar, we are talking about costs on NPV basis of ~$10 MM IF it sells better than the Street currently thinks. Hardly worth several percent off stock price after hours.
Jon
The most major one missing for Yahoo Finance is Bloomberg which seems to be the only one offered by Google Finance for those looking for source diversification.
Jon
It means that the fund could throw them in bankruptcy if no financing has occurred, and if a financing occurs with someone other than the fund, they have still given up the warrants, they must pay an extra $1 MM in principal to the fund (if it does not like the terms of other financing and therefore does not convert) and it must pay the fund up to $2 MM in fees. Ugly! Disclosure: Not a stock I follow, but just trying to help out.
Jon
Healthcare spending articles:
http://www.siliconinvestor.com/readmsg.aspx?msgid=23168678
http://www.siliconinvestor.com/readmsg.aspx?msgid=23168690
Interesting tidbits:
1. Healthcare spending now growing in line with GDP (slightly over)
2. Slowest growth in several years
3. Drug spending less than healthcare growth for first time - probably a reason drug stocks have been mediocre over last few years
4. Drug spending only at 10% of total spending
5. Consumer DIRECTLY impacted by drug spending much more than other items - another main reason drug pricing gets so much attention when the hospitals are so much more of the pie.
Jon
Hong Kong milk tea is actually quite good. Blend of different teas with a bunch of milk and usually too much sugar.
Jon
You have probably noticed that there is a huge volume number reported as late trades on some systems and which shows up on some systems as a change in price. This is usually reported to 4 figures like 60.3456. I think this has something to do with these trades but not sure exactly how it ties together. These trades certainly are much bigger on high movement days.
Jon
Wow - that was pretty neat.
Jon
I got turned on just for reporting on the analyst.
Jon
DNA
Realmoney out saying Pertuzumab did not meet endpoint.
Marc Lichtenfeld
More Genentech
1/5/2007 10:36 AM EST
OK, this is odd. In Genentech's (DNA: NYSE) press release touting the "encouraging" results from a Phase II study on ovarian cancer fighter Pertuzumab, no data was provided.
But according to Jason Kantor of RBC Capital Markets, the primary endpoint of progression-free survival was not met. He adds that the progression-free curves look positive and the results may be good enough to move the program forward, depending on results from a Roche sponsored trial. Data from the Roche trial is expected in the first half of the year.
Certainly not as positive as the press release would have you believe.
Jon
Obviously more info is better but I do find lack of real info in the data these days. I occasionally try out hitting what look like weak asks to test out how good the info is (usually less than 2-3K shares with maximum gains/losses of a few hundred dollars - more to gauge worth of info and occasionally capture a bigger gain).
It can be misleading. There are days where I have gotten IDIX to move 10-15 cents just by posting 2K share bids and moving them up as asks pull away. Other days the 2K bid gets hit in less time than it takes to show on my system as a bid. Even days where the ask looks benign. That being said, the illiquidity in IDIX can make for some interesting day trades, which given my time zone here in Hong Kong, I do not do very often. More out of boredom if I cannot sleep.
Jon