Looks like the court overturning Bloomberg's big drink ban went over well with Ariad analysts...?!

More germaine news anyone?

Remind me what Rachel's FY top line estimate was? $28M? Or did she bump that up?

Based on these reported Rx numbers alone, we're on track for $28M in top line this year....

Sweet.

If those two companies ever get together, it will be because Ariad bought Merck.

<wink>

Actually, I don't think ARIA can control the Iclusig black box issue by changing their MTD practice in '113.

The Iclusig black box is (according to the oncologists overseeing the study) based on adverse events that were seen in the trial population but NOT attributable to Iclusig.

If ARIA is going to run another no-placebo-control or no-standard-of-care-control pivotal registration trial, we have to be ready for a '113 label that includes every adverse event in the trial in addition to those that are considered traceable to '113.

The Iclusig shock stemmed from a label that had a whole host of potentially lethal side effects that had never been discussed in any of the presentations. Since we are all a bit savvier now, I'd like to think that someone will offer or ask for the whole list of AEs during the '113 registration trial.

But as long as the '113 label will have all AEs regardless of whether they are traceable to the drug, the MTD decision won't be a benefit or a harm.

Jeez -- we really still run this stuff with a true placebo arm, huh? That's pretty tough.

I always kind of wish there were some way to use a meta-study control from a large population of randomized prior records from GIST failures.

I remember when they were running Rida with a placebo control and thinking that "watchful waiting" wasn't that big a deal because of the type of cancer and treatment.

Anyway....

Ooo -- I know! Buyout!

No, wait -- Manipulation!

Novartis?



ManipulArtisOut?






</snark>

No problem -- you shouldn't ever feel you have to apologize to me for writing anything you have some rational basis for -- and any number of other things either.

My point was just that somebody's model said this thing was worth $25 on Dec. 13 and $19 on Dec. 14.

While we may not see a single-monster-candlestick recovery to $25, I think that the models do respond to current-period earnings.

Show me a surprise Q1 top line, and I have to expect a pop.

Long term, I think the call is even easier.

Why so glum?

My take (which is worth what you paid for it) is that the investment market looks at this quite differently from the way we do.

They believe the label because, well ... it's the label. And they recoiled because the label suggested little to no use in 2nd line, pushing cash flows into the future.

Call me optimistic, but I find it difficult to believe that if Ariad puts up better-than-expected top line numbers for Q1 the market shrugs that off.

Pipeline is important, but current- and near-period revenues are what cause wholesale shifts in pricing models. We got burned by this in December; why imagine the knife doesn't cut both ways?

Somehow, I don't think a box or not around the warning is the arbiter of success here.

If doctors in a jurisdiction know that there is no box, even for lethal side effects, then they know to just read what it says.

My underlying point was that we are still learning how regulators deal with drugs that are approved without a control-arm trial. In the US, we got an unpleasant surprise. The good news is that I don't think the EU folks could think up anything more to add to the label that could make it worse, so the EU label shouldn't be a negative.

That said, the nature of a black swan event is that everyone agrees ex ante that it can't happen -- so I'm just trying to keep our minds open and add some levity.

Hopefully, the EU label will be the same label that everyone knows and [loves | hates].

I agree, although I didn't think the US label was going to be a big deal either....

I suppose we're lucky that no one in the US cohort had gender reassignment surgery during the trial. I'm sure the FDA would have made sure to include that risk too!

I agree.

It all depends on what the EU label says the possible side effects are!

It was a joke -- the price was rising steadily for about an hour, and my comment was poking some good-natured fun at the folks who are (IMHO) a bit too quick to demand an investigation when our share price sells off.

Perhaps you may have missed the subtle "</snark>" in white text at the bottom?

Some hedge fund is clearly manipulating the price!

The SEC should look into who lifted every ask for an hour! Outrageous!

</snark>

So if all those folks stay on Iclusig for the rest of the year, that's about $16.5 million.

If IMS is under-tracking by half, that's about Rachel's full-year top-line estimate done and dusted.

I'm going to call this positive news.

Funny you mention it -- since it seems at least one person wasn't surprised:

<start>
Financial adviser charged with illegally providing insider information

Foley & Lardner LLP
Michael G. Dana, Peter D. Fetzer and Terry D. Nelson
USA
February 27 2013

One of the hot topic areas of concern for the SEC is the use of material non-public trading information by professionals within the financial services industry. In this case against a Florida-based financial adviser, Kevin L. Dowd, the SEC alleges that, while Mr. Dowd did not personally trade on the material insider information, he did benefit monetarily by tipping the information to a person who traded on it.

According to the SEC, Mr. Dowd received details about an impeding acquisition of Pharmasset, Inc. in his capacity as a financial adviser for a registered broker-dealer. Mr. Dowd allegedly passed on the information to a friend in the penny stock promotion business, who traded on the information along with another person he “tipped,” resulting in profits in just two trading days of more than $700,000. Mr. Dowd, although he did not personally trade on the non-material information, did benefit by tipping the information though the receipt of a $35,000 payment and a jet ski dock from the tippee.

According to the SEC, as a financial advisor, Mr. Dowd should have known better and refrained from both tipping others and benefiting from such actions.

The SEC’s civil complaint was filed by the SEC in federal court in New Jersey and alleges that Mr. Dowd violated Sections 10(b) and (14)(e) of the Securities Exchange Act of 1934 and Rule 10b-5 and 14e-3 thereunder. The SEC is seeking disgorgement of Mr. Dowd’s ill-gotten gains, a financial penalty ,and permanent injunction against Mr. Dowd. In addition, the U.S. Attorney’s Office for the District of New Jersey, in a parallel action, announced criminal charges against Mr. Dowd.
<end>

Ariad has it's own run-in with hedge fund inside-info traders. Thankfully, no harm was done to the company.

I agree, and did say that.

But this is the type of instance that was a chance to sell "Berger: the Ariad Leader," and "Iclusig: Potential for Numerous Cancers" -- all kinds of stuff. Cramer's questions were softballs -- why turn them into "oh, um, yes, well, our sales force is challenged"?

Just my disappointment speaking.


Cramer acted like a normal TV host. You can see that he has this gear when he participates in other shows in the AM. He turns on the "Mad Money" shtick for his show.

I suspect that JC's opinion is that he was fully justified in his caution given (1) the overall likelihood of development-stage success, and (2) rida.


Iclusig scrips -- that's the topic! Show me the money!!

Useless thoughts on HB & JC:

Cramer is not looking for the Ariads of the world. He calls stocks based on conventional wisdom (at best), and that meant in the past being skeptical about Ariad's chances. He said as much on at least two occasions.

I see this appearance as a let's-bury-the-hatchet type of interview: Cramer admits he was wrong and Berger doesn't boycott the show, giving FoxBiz 100% of the face time.

Tactically -- and this is totally MH(stupid)O -- I think that HB's appearances are best geared to the medical and scientific communities.

I don't find HB's voice and diction of the type that I respond to for inspiring, transformational leadership. I'm far from mainstream, so that doesn't bother me, but I always think that when HB speaks, he really has to bring a message -- don't expect a Steve Jobs-type reality distortion effect.

Visually, HB's habit of carrying his head at an angle and further tilting his head for emphasis runs contrary to my understanding of gestures in forensics (the definition meaning public address) insofar as it may be perceived as feminine. (Not that there's anything wrong with that....)

Overall, in this interview, I thought that his responses were ... fine. But he tended to make the rhetorical mistakes that regular people make all the time (which I understand, since HB is a human being) but which I wish a CEO would have drilled out of his delivery.

- He seemed to say that Iclusig couldn't be a $1B/year drug without a 1st-line approval. Do we think that's what he meant? I didn't that that was the case.

- When JC asks him "what's your sales pitch" vs. the major pharmas, HB said, "Umm...you know, I think, I think that's the challenge." I do not care what you say after that initial lead-in -- all the Bill Ackmans of the world just tuned out. Sounds like a three-legged kitten made of over-cooked pasta: weak. He should really have something locked and loaded for that question. "Look at the data -- that's what we tell them." Something blunt and cocky.

- "How do you compete against Pfizer?" HB says that Ariad's advantage is that their sales force is exclusively focused on Iclusig? ORLY? That's our advantage?! Somehow I got the impression that Iclusig was a better drug that Bosulif -- is that not worth mentioning? Where's the confidence in the science?

- On getting bought: "We've tried to position the company in a distinguishable way." What does that even mean? That type of corp-speak is fine for 2nd-rate consultants and mid-level chumps, but IMHO, it is not befitting of a CEO.

</rant>

<sigh> Onward and [up?]ward.

Yes -- IMO we held up well despite Beppe & Bunga Bunga rocking the boat.

> winking

> nodding

> ripping off his clothes and running about with a stiffy screaming, "I'M GONNA BUY ME A FREAKIN' ISLAND!!"

I suppose I'll take whichever, but you know....

If you're interested in entertaining my unicorn-and-skittles pipe dream, think of it this way:

HB didn't schedule an investor presentation. He scheduled a break-out session where he can give a nuanced, off-the-record, body-language imbued message to the Wall St. folks; the presentation is just the corn starch and sugar that make up the other 99% of the pill.

</daydreaming>

My immediate take-aways:

+ IMS cap rate is low; scripts are better than we thought.

- "Market confusion" with Bosulif ... RLY?!

Technically, the press release relates to the period ending 12/31, so that's likely why they didn't include Iclusig sales.

If HB doesn't say anything about Rx numbers, someone will ask.

Umm...yeah. Let me get get right on that homework assignment.

Dude -- we wish! That was two financings ago....

Hmmm ...

We need some unemployed Kremlin-ologists to read the tea leaves here:

Do we think this means that HB has good news and wants to talk about it two days in a row?

Or do we think HB wants to have a break-out session to explain what's up off the record since he realizes it's going to be tepid?

It'd be nice if not everything was a major binary event...but for that, there's always some type of weak-stomach mutual fund I suppose!

Oh, I do.

And I also know better than to rely on the Daily Mail for my science news!

True, a broken clock is right twice a day, but I'll wait for a second source.

Walmart emails leak, asking “Well, we just had one of those weeks here at Walmart U.S. Where are all the customers? And where’s their money?”

Whole market is taking a dirt nap and ARIA is no exception.

For better or worse, we're now much more highly correlated with the broader market....

My understanding was that we have data for 5 weeks, and that it showed that they had ~80% of the Q1 estimate.

No problem.

Happens to the best of us -- and me, too!

I'm going to disagree with this part.

Good point -- they could have lots of small-molecule drugs, or one monster do-deca-bucky-ball molecule that you can see with the naked eye.

"Here you go -- please swallow your one-molecule-a-day dose with a glass of water."

HB's never been dead set against partnering -- earlier in the pona and '113 development story, they included partnership agreements for these drugs as possible sources of financing in their SEC filings.

I suspect that what HB won't do is partner the drug when he thinks that he can demonstrate reasonably the great value proposition and he has a viable market financing option -- even if it is a $1.69 PIPE.

Assuming that ARIA does have a molecule in the lab, my WAG is that HB's assessment goes like this:

'We don't have the cash to run more trials, and we don't think that someone else will come up with this specific compound in the next few years. So just keep pursuing it in the lab as far as we can, basically relying on trade secret-type protections, so that the patent period doesn't start to run. When we do roll it out, we'll have a great amount of lab data so the FDA will be impressed and let us run our short-and-sweet PH 1+2, then Pivotal trial system.'

No doubt, but the Daubert standard (IIRC) is designed to keep pseudoscience out of the courtroom, but does little to protect against cherry-picked or fig-leaf arguments.

Consider this classic battle of experts [LINK]:

Thanks -- absolute hilarity!

My favorite was the (spoiler alert) crescendo conclusion:

HAHAHAHA. Right. This guy is one of those people who sits at a poker table playing 7-stud, limping along until he makes an ace-flush with 4 cards showing and makes his HUGE bet...and wonders why everyone folds.

What a maroon. He's probably waiting on follow-up data for the aspirin trial to go long Bayer.

I think they'll have to, since the EPIC trial is double-blind with a control arm.

It would be funny (if you have that sense of humor) if they stopped EPIC early due to efficacy, and then said, "Sorry -- can't change the label, since we don't have enough data on AEs."

Ultimately, the label will represent actual patient treatment experience, but the changes may only come long after everyone has stopped paying attention to the black box.

Agreed, although insurers will no doubt want to see Glivec/generic Imatinib use first.

The REAL success would be to show that Iclusig patients could stop treatment at some point. Once you can give the payor an expected end date to treatment, I think their models will swing in Iclusig's favor -- especially in the low-interest rate environment.

I agree that this should show some positive results -- likely the first evidence of how well Pona can work in otherwise healthy CML patients, and an early indicator of what the warning label should really look like.

Not to be a wet blanket, but this trial started last April with a target study population of 50 -- and was still recruiting, at least as of October and likely now since I'd expect a prompt update if they closed the trial.

I suppose this gives us an idea of what the incidence of CML is in the Houston, TX area....

So is this the Inclusig Rx picture so far?

Wk.....#Rx
1......3
2......10
3......18
4......x
5......y s.t. 2x < y < (x+31) but "close to x+31"

Even if we use x=0 and y=25, that gives us 56 prescriptions and 1Q estimated revenue of

($115,000/52)*[(3*12)+(10*11)+(18*9)+(0*8)+(25*7)] = $1,068,173

and full-year of almost $6 million.

The big numbers aren't there yet, but I'm calling this good news.

Stellar.

Now I just have to stop worrying about a cram-down MLBO.... <sigh>

Trolling the web, I noticed that a '113 patient had posted brain scans from about 5 months apart, IIRC, after switching from Crz.

Significant brain mets had simply disappeared, and the largest was vague and dark, like scar tissue. One data point, but....