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Slow news day, so if anyone is interested in reading the recent decision, it's here:
http://db.tt/GcsXnFK9
It's 68 pages, but it's also in double-spaced Courier, so if you're a slow reader like me, you should get an ego boost out of burning through it pretty quickly....
As I said then, different case.
Yes -- the decision was just released. There is no news link yet.
Well, nobody apologizes to big tobacco for having claimed that smoking is unhealthy.
When the facts turn out to be facts, you don't get an apology for having had the facts stated as facts.
The 483 is real. You've seen it.
The content of the article was 100% accurate. It was quoted from the 483.
What would the apology be for? Threatening to shake one person's blind faith in HB? Apostasy?
Zany post.
All you have to do is look at the dates and realize this was when ARIAD was having a most difficult time.
Interesting that this flew under the radar.
One would think the current management would be bending over backwards to mend its relationship with the FDA, especially by doing the simple (and explicitly required) things -- although it was nice of them to call Iclusig a "blockbuster":
Late Reports on Adverse Events Land Ariad Pharmaceuticals 483
March 13, 2015
Ariad Pharmaceuticals failed to submit a slew of adverse event reports within the 15-day deadline and follow the risk evaluation and mitigation strategy for its blockbuster leukemia drug Iclusig, prompting a 483.
During an October inspection of the company’s Cambridge, Mass., facility, investigators discovered various discrepancies with Ariad’s adverse event reports.
For instance, the drugmaker failed to submit to the FDA five reports within 15 days of initial receipt of the adverse event, in violation of agency regulations. In one instance, Ariad received a report on Oct. 15, 2013, and didn’t let FDA know until Dec. 20 of that year.
Field alert reports also were not submitted within three working days of identifying a problem with a batch, the FDA said in the six-observation form. Ariad failed to submit four FARs for batches that had foreign tablets, did not dissolve properly and contained the wrong amount of tablets.
Ariad also failed to follow up on two serious adverse events: one for a patient who experienced a stroke after taking Iclusig and another for a patient who was hospitalized.
And the drugmaker did not publish advertisements in medical journals throughout 2014, as required by Iclusig’s REMS. Ariad was required to publish ads in a journal during the second and third quarter of 2014. The company was also required to publish ads in a second journal in the third quarter. However, no ads were published during that time.
Ariad said it has responded to the FDA and is addressing the findings.
This is the opposite of what some people here are hoping to happen...
lawsuit thrown out by the court for lack of merit.
in the eyes of the law, HB and the BOD didn't lie
Just so we're clear, the two competing explanations are:
1. HB, in a brazen yet subtle effort to signal his absolute certainty about his plan, intentionally omitted the safe harbor statement; or
2. HB did not recite the boring-but-necessary safe harbor statement because it was provided on the webcast site (but did say it when the webcast site did not provide it).
This is my 5th post on this, so I'll leave it here. People can decide whether they're going to take the red pill or the blue pill.
The question is why HB clearly stated the safe harbor statement in at the beginning of the Cowen webcast, but not in the one with RBC Capital?
Well, without offering any type of legal advice or analysis, I think you are incorrect.
Yes, and my post was a response to zuzie's that noted that the statement was not read during the presentation and suggested that it was not in fact included.
Just pointing out that it was there.
Ariad Pharmaceuticals ($ARIA) just relaunched its leukemia drug Iclusig last week . . . .
We could go up just on the rumor found in this announcement.
I'm just noting that heavily shorted stocks have seen up-swings outperforming the market. Ariad is heavily shorted and is having up-swings that out-perform the market.
Maybe it's a leak about a deal or the new drug.
My point is just that I don't expect either prior to or at the Leerink conference, though I'd be pleased to be wrong because it would move up time lines.
Which, by the way, isn't that Ariad isn't going up or going to go up.
Rather, it's just that the current crop of sharp moves isn't based on some leaked info.
Now I'd be happy to be wrong -- if we get some movement on a '113 partnership (which I have pushed for since the for-pete's-sake-it's-not-a-flash-crash) or some detail on the new molecule in the near term, I'll be happy to attribute part of this to news.
And I'd go so far as to include anything HB says at Leerink -- I suspect those presentation slides are getting put together and as soon as they are roughed out, the info starts to seep into the market.
Otherwise, I'm guessing it's margin calls. For now.
Thanks -- I was hoping to get more input.
If folks are interested, I can post some terminal charts on a periodic-if-spotty basis comparing ARIA to other benchmarks.
I usually look at the period beginning on Dec. 20, 2013, which is when Iclusig was reintroduced to the market. That seems to be the time frame that shows how well ARIA management is navigating the waters.
If anyone has any others -- specific companies that you think are good comparators -- let me know.
Open question for the board:
What benchmark do posters think is a reasonable comparator for Ariad?
Given that various people critique or support the performance of Ariad, what are we looking at as a reference point for "good" or "bad"?
For example, the IBB biotech ETF could be an easy (if inexact) performance benchmark.
Thoughts?
Agreed -- as long as you don't think that Ariad's lab is all it's cracked up to be, then the partnership of '113 is a mistake.
As for delivering drugs, I agree Ariad has fizzled -- but the question is whether we attribute that to the lab or to post-discovery management (the functions that would be done by a partner).
Whatever we think of the Pona partnerships, I highly doubt '113 will go on the same terms. Pona is murky. '113 not so -- an Excel sheet could model '113 in a way that most people can agree on, which makes negotiations easier and the price higher.
We agree on many points, but I think partnering '113 is a great move. I have for a long time: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=93893300
The underlying question is whether you think that Ariad has the real lab and repeatable molecule design capacity that has been attributed to them. If you do, then I'd suggest not being too attached to '113.
'113 has a well defined patient population, a(n increasingly) well understood side effect profile, and a pretty clear path to approval. Most of the deep thinking has been done -- now what '113 needs is heavy lifting.
Ariad should get as much as they can for '113 now and use that to move forward their invention process. If they really do have a bench that can create new drugs on a regular basis, then that is Ariad's competitive advantage and they should focus on that.
That's not to say that they should sell of drugs they don't need to sell. But that the luxury of keeping drugs and running the trial-approval-marketing part has been pushed off by Iclusig's anemic return.
I'm just disappointed that it took them over a year to adopt my suggestion -- perhaps Denner didn't see it as the "baloney" that one responder here thought.
While I don't know, I would assume that the index is market cap weighted, so I don't think that Ariad is going to dominate.
And the index tracks the performance of its components -- Ariad wouldn't rise because a non-public terminal model portfolio rose.
So on those elements, we can agree to disagree. Although earnings is in the offing for Ariad, they pre-announced, so I don't see those results being much of a catalyst. IMO, buying pressure at this time of low news flow is much more likely to arise from external forces.
On your chart, I agree -- I misread the number of periods as days, so yes, it's the same two-day period. That said, I don't think that looking at two stocks that may or may not be part of the index contradicts the underlying idea.
Anyway, we're up and if that's because some shorts got an unwelcome call from their brokers, that a plus.
Fair enough -- the "Most Shorted" index is actually a proprietary Goldman index that's only available to GS clients on the Bloomberg Terminal.
I've tried to check it from the terminal that have some access to, but can't pull it up. So I can't even tell you how many stocks are in it. That said, Ariad is generally in the top 20 most shorted stocks on the terminal's own listing.
Choosing two other stocks that may be in there and then looking at their long-term performance doesn't quite disprove my point about intra-day moves yesterday and extrapolated to today, but it's fine to be skeptical.
Skepticism is a great tool -- especially when applied even-handedly.
Cheers -- gotta get back to workworkwork.
If I had to take a guess (which is to say, I don't know the answer for certain) I think it would have to do with how broadly the market's poor performance is affecting issues outside the narrow indexes, S&P500 and DJ Comp.
However, this could cut either of two ways:
If the short interest holders have concentrated long positions in big names, then you would expect Ariad to outperform when the S&P has a bad day (causing margin calls) but other off-index stocks do better. The comparison with the Russel would suggest this isn't the case.
If the shorts are concentrated in, for example, other biotechs or other small- to mid-caps that aren't on the S&P, then the effect would be strongest when the market downdraft is broadest, with many sectors showing weakness.
</speculation>
The discussion was about yesterday and today. The chart is from yesterday. The short chart is from today. Ariad hasn't closed in the 5s since November, so I have no real idea what you're talking about.
And this isn't the first time we've seen this -- I've posted that most-shorted chart out-performing before.
You don't have to buy anything, and should feel free to believe JessPro's "there's stuff going on behind the curtain" mantra. The point of the post was that commenters yesterday and today were saying:
"Wow -- we're going up two days when the market is doing poorly. I wonder why!"
"Yeah -- no news! Maybe news is coming!"
Those charts offer a real-world explanation based on actual data. Or, choose what's behind "door number two."
The last time HB pulled the big reveal, it was that '113 killed a guy and Iclusig would be pulled.
Are you excited to hear how many patients are actually ON Iclusig? Even when Ariad has been hiding that figure for a year now? HB just has to be "saving" an awesome piece of news, right?
Let's hope what's behind the remaining door isn't a Monty Hall zonk.
I didn't read it so much as a criticism of Ariad, but as a factor in the discussion of Ariad's need for cash/financing/dilution -- IIRC, this has been 2damoon's general premise.
Given that Ariad refuses to discuss how many patients are actually on Iclusig at any given time, and that as per Duvall on the last conf call, 700 patients had been "treated commercially with Iclusig" through October, 2014, I think that 450 patients in a trial may present a dent to top line.
I agree the trial is good, but I think the point was that it was have an opoortunity cost in addition to the cost of running the trial itself.
Exactly -- I'm just saying that Ariad isn't the only party who has an interest in the confidentiality of the deal terms. Otsuka may have asked Ariad for confidentiality of a term that Ariad would have otherwise wanted to make public.
If you recall with the Merck deal, they were clear about the milestone terms but never said what the sales percentage was -- just "low double digits" after being pressed by analysts. I'm confident that those (non-)disclosures were requested by Merck to protect other negotiations.
Same here -- I think we can't say that no news is bad news since Ariad isn't the sole arbiter of what terms are made public.
Also keep in mind that Otsuka would want to keep rich terms for Ariad private -- they negotiate deals with other companies and don't want to hear "you gave Ariad [x]%, so why not us?"
Generally, I'm not sanguine about anything that Ariad doesn't trumpet (if they won't tell you, it's probably bad news) but in this case, I'd say we just can't infer much.
Even Ariad itself doesn't hawk this trope any more.
I think there's just too much straight-up incorrect stuff on this board to really try to correct.
I can't really take the agitprop level here anymore.
No problem.
My sense is that a substantial amount of disageement on lots of message boards stems from people not talking about the same thing -- sort of talking past each other in increasingly belligerent tone.
Semantics are boring, but it's what keeps things civilised.
The float is the amount of actual issued shares. The actual shares outstanding can be greater and can include unissued shares. Those unissued shares do not go into the computation of the market cap. All the shares in the float go into the computation of the market cap.
They are selling 6.25M shares @ $15-17, so the IPO is expected to raise $93.75-106.25M. Common stock offered by us
From p. 8 of the S-1:
6,250,000 shares
Common stock to be outstanding after this offering
24,782,240 shares
The $370M - $420M market cap figure was based on the 24+M shares expected to be outstanding after the IPO, no?
True, but if I recall correctly, the licensed patents did not have much more time on them. Someone can correct me on this.
I think the whole deal was about giving BLCM a clean, uncluttered profile for the IPO.
That was the number that I had in my head too, but I was concerned I was conflating that with the "low-double digits royalty" on Rida sales in the Merck deal.
We'll see what BLCM prices out at and what kind of IPO premium the trading market gives it.
It looks like Araid did take a haircut on its exit, but perhaps not a bath. Of course, if BLCM really does cure GvH, then Ariad will not look good in hindsight, but the company's horizon is currently too short for that kind of thinking.