<In the 200 mg/day arm (arm B*; n=31), 87 percent of patients achieved an early virologic response (EVR), defined as greater than or equal to 2 log10 (100-fold) reduction in virus after 12 weeks of treatment, compared to 88 percent in the pooled 800 mg/day arms (arms C, D and E*; n=92). At 12 and 16 weeks, 71 percent and 73 percent, respectively, of patients in the 200 mg/day arm reached undetectable virus levels below 600 copies/mL compared to 73 percent and 74 percent in the pooled 800 mg/day arms. After 12 and 16 weeks, 45 percent and 62 percent, respectively, of patients in the 200 mg/day arm reached undetectable virus levels below 20 copies/mL, compared to 56 percent and 61 percent in the pooled 800 mg/day arms. >

From Bear Stearns:
"The key question is whether lower doses of NM-283 are efficacious". We maintain that the answer is unknowable at this time, and this is probably why the FDA won't allow initiation of Phase III until more data collected."

Looking good so far...

IDIX- Dew

How exactly do the 8 & 12 wk viral clearance or log load reduction data for NM283 in the Ph IIb compare thus far to similar published 8 wk data for Pegasys? I'm a bit busy right now or I would search on my own. Hopefully you have that data on hand?

IDIX- I sure hope there's no bad conference or NM283 news coming- i left for an afternoon soccer match and came back to see that i got filled at 9.92 (I think on that last swoop down toward the close). You think we see any covering on Monday? Today was a fairly high volume day...

IDIX...

There she goes, touching 10 again... When will the insanity stop?

Dew, the license agreement in the 10-k is worded poorly then. I was aware of the payments received and to be received near-term, but as i read the PRs and 10-k it appeared that the $525 aggregate was solely for license fees and regulatory milestones. ADDITIONAL payments would infer payments beyond the $525 for any potential sales milestones.

As for the PV calcs, obviously approval is quite a few years out there and with PJ's DCF model using 35% is a bit extreme for mainly mild and moderate GI side effects.

Your thoughts?

Of the $525M cumulative amount for the HCV program, IDIX received $25M on March 29 when NVS exercised its option to license NM283, and IDIX will receive another $45M when NM283 enters phase-3 trials in the U.S. late this year or early in 2007. The remaining $455M is based on unspecified regulatory and sales milestones.

IDIX

Have I read this wrong or will Novartis pay IDIX a sum nearly equal to IDIX's current mkt cap if valopicitabine makes it through approval???

If Novartis exercises its option to collaborate with us on valopicitabine, it would be required to provide development funding for this product candidate and pay us up to $525 million in license fees and other payments based upon achievement of certain regulatory milestones as updated in the amendment, as well as additional milestone payments based upon achievement of predetermined sales levels.

The additional sales milestones are icing on the cake. What's not to like even if VRTX's vx950 doesn't hit a snag in further trials?

I can't believe that the GI side effects of NM283 would be major enough to keep it off the market at 400 mg, let alone 200. With my current purchases at this price NM283's sales prospects vs vx950 are moot. The payout is there as long as it advances to market. All IMO

KC

Dew <In the HCV arena, the report covers no new ground beyond the potential competition from VRTX’s VX-950 and the newfound risk posed by the Telbivudine dose reduction (the action that caused IDIX to drop by 30% on March 24). I’m considerably less worried about VX-950 than PJ is because: a) The VX-950 data are very early; b) VX-950 may not be suitable for once-daily dosing; and c) As a protease inhibitor, VX-950 could eventually complement Telbivudine in an all-oral (no interferon) cocktail.
>

Do you mean Valopcitibine? NM283 or what not is being re-dosed, not the HBV drug...

Coinstarz - Freezer issue...

<Next year when 2nd iPlex hits the market, the freezer issue will be gone, and iPlex will dominate the IGFD market. >

Per PJ Young:

"As noted in the package insert for iPlex, household freezers work just fine. However, we are always striving to improve our product offering. As such, we are in the process of developing a room temperature stable, multi-use formulation, which should be available early next year."

What's the issue with the household freezer? I don't see any formidable problem, such as a medical-grade frzr might have imposed. Are you talking about the development of room temp stable iPlex when you say '2nd iPlex'?

DNDN >>
Here are some other predictions:

1. DNDN will not in the near future be able to attract a commercialization partner for Provenge on the kinds of terms one would ordinarily expect for a post-phase-3 product in a large medical indication such as prostate cancer.

2. One or more additional senior executives will leave the company before the BLA is approved.

3. DNDN will talk less often about its manufacturing buildout because these plans will be moved to the back burner.

JMHO, FWIW. If I’m wrong, I’ll be the first to admit it.
<<

Dew, even if stratification and small trial size turn out to be a hold up in the regulatory process, I can't believe that the FDA would neglect the largest survival benefit to date (despite the underpowered trials) AND the non-toxic profile.
A confirmatory 9902b, post-marketing might be expected.

I believe that your forecasting ability of this regulatory event will be similar to that of GTCB... And when it does, I will be sure to come back here to toot my own horn like ONE regular poster on this board often does.

Yep, I still believe the clinical story is strong and that the FDA under current leadership will give an unconditional approval... So in the longterm, I reason it a strong buy at these levels, but over the past 1 yr + it has been so painful day in and day out that I am reluctant to subject myself to any more "pain." Such is the market.

Hey, considering picking up more at 4.33, just don't know-- I've been holding since 2003 and have too much already. Obviously never thought we'd be at 4/share 4 months pre BLA filing. Seems that this may be the flush prior to the filing... but is it another beginning or the end of the flush? YA never know.

My basis for my last post was PGS's post below on YMB:

However, the comment regarding the discrepancy in covariates is rock solid.

In yesterday's CC, management emphasized in the prepared remarks section that the MVR used was the exact same one in both 9902A and 9901. The importance of this has been expounded on this board leading up to and after this latest data release.

The first question in the Q&A was by monane, who asked for more detail on the Cox MVR. Management, or specifically hershberg, starts to answer and rings off 4 of the 5 covariates rapidly (ldh, psa, #bone mets, weight), and then pauses... then both Gold and hershberg both pipe in with "alkaline phosphatase"

Now go to Small's presentation at ASCO's annual meeting (hope link below works). Slide 23 he lists the specific 5 that were used. Alkaline phosphatase isn't one of the 5... disease location is.

Well, despite Gold and Hershy's brain fart during the CC, it has since been clarified that the covariates were the same... so what was the hype? It would have been much more beneficial to 02a's pvalue had they done an independent Cox analysis of the trial- that's why i don't follow PGS's 9901 Cox rigging/all around mgmnt corruption theory.

When 9902a p-values were made public, most were releaved that DNDN had not attempted to maximize the benefit of Cox analysis by finding and using the 5 most significant variables in 02a alone. I am pretty sure that many posters on YMB such as PGS were suggesting that the above method was not the appropriate way to carry out the analysis such that confirmation of 9901 could be achieved (this was before it was known publicly which method of Cox analysis was used). Seems to me the grass is always greener on the other side.

Concerning CHMP outcomes- (Dew) can we take these stats, courtesy of a YMB poster, at face value? Realizing of course that many unfavorable apps are withdrawn prior to meeting time at the committee's request...


http://www.emea.eu.int/pdfs/human/press/pr/3500606en.pdf

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