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Hope so. There are still a number of pona posters to be presented at ASH in this evening's session, which starts at 6pm Pacific. The titles and abstracts have all been available on the ASH website, so I would not imagine any surprises, but there might be some good words for us.
I don't have access to trading data, but the shorts may have market-sentiment on their side for a few hours here; DAX, FTSE, S&P, and DJI are all down.
But I still think we will see positive action tomorrow, after this evening's talks at ASH.
Is anyone on this board at ASH? Would be interesting to know what kind of a buzz there might be around the posters.
I agree. And to return to my now rather boring mantra of two years ago, these results should encourage off-label use; that is what will drive both the use of the drug and the pps.
Was expecting more of a pop this morning (we are 30 minutes in as I write this), but what I see as the "big talks" are not until after the market closes today - at least according to the agenda published by ASH.
And looks like they have all those poster slots to cover all angles of pona AEs (and perhaps maximize the number of people who get to go!). Looks very thorough - but anything really new?
I was hoping for some non-pona posters, although we may have to wait for spring and ASCO......
Saw the poster titles for ASH. Anything other than pona to be presented? (I didn't see anything).
Nice day - let's see how the AH holds up.
Good point BR, and none of us (me included) should cherry-pick the data. But the paper does consider the data you note, and it provides the impetus for the group to work on a molecule to be used in combo with pona, that would allow lower dosing of pona.
In other words, a group that is apparently not associated with ARIAD has decided that pona is a good horse to pull its own (new drug) wagon. Not a bad endorsement.
Nice find, and an unusually readable paper. The group writing is taking the position that pona would be best as part of a combo therapy; from the last page
"The toxicity profile of ponatinib, however, precludes its use alone as a frontline agent.48 To circumvent this unwanted toxicity, one possibility may include using ponatinib in combination with other therapeutic agents to allow for dose-lowering of ponatinib."
Dose-lowering is not new news, and their objective and positive view of the drug generally is gratifying. One quote (on page 244) in particular;
"However, in nearly one-third of patients, first-line TKI treatment will eventually become ineffective, forcing patients to start on another TKI.12 Most patients will convert to either nilotinib or dasatinib. However, for some patients, especially those possessing the T315I kinase domain mutation, ponatinib (Iclusig®) will be the ideal TKI."
So we get truly good news for pona on Tuesday (clintrials posting noted by Jaybee was dated Sept 30) and breakthrough status on '113 today....and we are up less than 10% in a market where anyone should be scrambling for single stocks with good news.
I am forced to conclude that forces other than those of good science and good data are present - and as a scientist, this is very painful.
Ariad's BoD needs to show the world something - anything - new and positive on the management front.
When is the next BoD meeting? Anyone know?
The last secondary was at $19.60 , if you really want to set a target. That seems a bit on the high side (but would be nice!!)
And given today's bad news with BMS, Exelixis, Novo etc. maybe ARIA looks pretty good......
The tweet by BMO that BR found should be enough for this, IMUO. Maybe we should all just re-tweet it.
We are nearly half-way through the day and down slightly on low volume - so i suspect the upcoming holiday is more on everyone's minds than anything else......
No disrespect to BR, but your reply is the best. I am tempted to tweet that the CEOs of all the major pharmas and generics were spotted together with HB on the same planet!! OMG!! That should drive the pps !!!
Very nice find; someone is reading the literature!
Can't resist saying it (again)..."off label use"...
Great prediction! Personally, I am predicting the end of the world when the markets close, unless it doesn't happen.
In anticipation of others recognizing the wit of your conditional prediction of a prediction, I will offer pre-emptive praise with the proviso that this message is revocable upon lack of any news over the next 7 hours.
And add the cost of sourcing & moving starting materials, and the diminishing differential in labor rates globally, and that local pharma shop down the street starts to look pretty attractive.....
A potential buyer (if on e exists - I am nervous) would value pona at what it is bringing in today, with some probability factor for non-US income.
But my opinion is that a potential buyer would only be buying the pipeline and the discovery team, and that pona - in any market - is just a nice plus on top of that.
Who? Well, CELG has been mentioned here before and they appear to be aggressive (and good!) at picking up platforms and pipelines. (And if they can get thalidomide back on the market, then their reg affairs folks should find a few blood clots easy to address!)
Just my completely uninformed opinion......
Ditto for me.
Wish I had something constructive to say, beyond "we are not dead yet and the sun continues to come up each morning".
They are right across from the Sydney Street garage - which was not too expensive the last time I was there. The Hotel@MIT (is it still called that?) is quite nice -although expensive.
And just think as you walk around that area, if JFK had lived, this entire area would be Mission Control - it was all planned, but LBJ moved it all to Houston!
Definitely - go for a walk in the evening on Boston Common and the Public Gardens.
OK - I'll bite.
Today (June 18th as I write this) is the 199th anniversary of the Battle of Waterloo, when Blücher showed up late and saved Wellington's butt.
Well, not sure what analogy to make or even what metaphor might be appropriate, but perhaps the Iron Duke's own words are best; "It was a near run thing - damn near".
ASH is Dec 6-9 this year, so maybe December is not a bad timeframe, as you suggest. Not that ASH would be a reason or a good place to make an announcement, but anything planned for presentation at ASH will need to finish data collection pretty soon - I figure July, or August at the latest.
Yeah - Tuesday would be good. I can wait until Dec 3. My wife's birthday is Dec 4th and I'd like to buy her something nice.
Good idea. And there is little pushback on pricing for orphan drugs because - they are orphan drugs - rarely used in the overall population, so very few claims for payment.
I still will beat the drum for off-label use (which means anything - not only front line), but as you suggest, let's just get it out there and generate a consistent revenue stream without making a big fuss.
I would have thought on interrupted/intermittent dosing regime would have been tried at some point; 2 weeks on, then 1 week off - with possibly a lower dose in between, something like that. Has this been done? Maybe I missed it.....
As I just posted, I don't believe in conspiracy theories, etc. But as I have also posted previously, I do hope that Ariad is putting something together around ASCO, even if it is just PR. Let's hope that there is more than that, i.e. some good data on a poster that gets some buzz going, or a minor but well-timed announcement.
I don't believe in conspiracy theories, nor do I put much stock in articles written by people whose job it is to turn out something everyday for the purpose of attracting advertising.
Ariad has an approved drug on the market and has revenue from it - not what was expected, but more than zero. Ariad has a pipeline as good as any other "small", "boutique", "niche" pharma, or whatever category you might chose to describe the company. Which rationally puts its valuation ahead of those still just selling the dream with nothing in front of the regulatory agencies at Phase 3.
Revenue from an approved product, a decent pipeline, and no need to worry about doing an IPO. Yes - an attractive small pharma investment here around $7, no question.
As vid says - just wish I had got a bit more out at 20 so I could buy more now. Bad timing is the story of my life....
I'll take a shot...
ASCO abstracts?
Unlikely. The posters/presentations for which these abstracts were put together weeks ago (if not before) and have been revised and reviewed and word-smithed to perfection. This is the same for every company, so I would be very surprised if there were any "new news" in anyone's abstracts, at least big news.
ASCO?
Possibly - and I hope so. This should be the best catalyst we have and if the company doesn't capitalize on it - even if just with some flashy PR - it will be a blot on sr. mgmt. Conferences are supposed to be places where announcements are made, even if they are minor ones, or even if it is just a senior person re-iterating something that was announced in the recent past.
I would really hope that there might be some announcement about trials re-starting, etc. That is not the sort of info that would get put into a poster abstract, and a conference like ASCO would be the right venue to make such public announcements.
Q2?
Possible, although less likely than at ASCO. Would be based on news about trials, and of course Nx/Rx numbers.
Q3?
Dunno.
Q4 2014 ?
Dunno , and I will have run out of food by then....
Hey BR - I'm on your side. And your photo is pretty cool too.....
I am pretty sure there is (and that it is a common thing, generally). What I meant in my comment is that there is nothing about enhancing an existing poison pill or creating a new on - hence no big deal, IMO.
If there WERE something -like new warrants etc - that would have signaled "no b/o".
BR, I take all this as standard business practices, and "business as usual", not an indication of any intention to avoid a b/o. If there had been some kind of poison-pill arrangement on the list, then I would agree with you. But there isn't.
Until there is an offer on the table - and public knowledge that there is - then "business as usual" seems the prudent course of action.
The real answer is that no one can predict this. As a single data-point, CLVS got a huge pop on the day of their presentation (not the day their abstract was released) at ASCO last year.
Nice post. My uninformed opinion on two possibilities:
1) Purchase by a big pharma/biotech. Lots of talk on this point here over the past few months, with our "consensus" (dare I call it that?) ranging between $15 and $20 (with extremes well outside that depending on the day!!)
2) A strategic retreat back to an R&D company with perhaps 30+ staff, and small revenues from wherever pona ends up.
#1 - we get some $$.
#2 - not sure that we get anything other than to keep our shares at something around $10-12.
If I were sr. mgmt - I would pick #2. An R&D company - already public - with a real pipeline and revenues (even tiny!) from an approved drug would be a great place to be.
I had suggested #2 when we were in the $2-3 range, and that it would be possible (then, last October) to take the company private with the cash on hand. Too late for that now.
Yeah, yeah - I know. "If you're so smart why aren't you rich?"
He certainly does express something other than a detached, technical, analytical tone in his articles. He has expressed his opinion many times, so not sure why he feels it necessary to repeat it; he has said nothing new.
I am not sure what "enterprise" value means, but a valuation of 13X doesn't seem terrible. AMZN has a P/E ratio of over 450.
No conspiracy theories are necessary - we are a trading stock. This morning's numbers didn't matter, nor do I believe AF's column made any difference either. Up on speculation Monday, then down for two sessions; about a 16% change in three days - not bad. Up tomorrow? Likely. Do I think any of this driven by real data, financial or technical? No.
Yes, ASCO should provide something - although I thought it would last year and it didn't. Let's hope the company has a plan of some kind - even if it is just PR
You're right - not now. Just prescribing it first-line - even if the patient demands it - would almost certainly be considered malpractice (unless the patient experienced a really positive result). But there will be enough data in the reviewed literature - eventually - to justify off-label use.
Have to admit that I missed the comment that the safety issues were Wall Street's problem - I agree, that does seem an imprudent statement.
But I do remember his comment about buying more stock if he could - that is what a CEO is supposed to say, unless he knows of something really wrong. And since he made that comment 6 months ahead of the crash, that seems unlikely. When I heard that statement in the CC, that's how I took it - a CEO just doin' the CEO thing, and nothing more.
Yes, I believe they would - and that would be the driver for off-label use.
Yes, but... I will return to what I said when I first became enthusiastic, and mention off-label use, i.e. using a drug in a manner not explicitly on the label, such as first-line when the approval is for second- or third-line.
Realistically, trials with reduced doses, on/off dosing schedules, or some other regime, would be great, and I believe would show very good therapeutic benefit and reduced side-effects in at least a portion of the patient population.
I am not a lawyer (and I don't even play one on TV), but there would have to be reasonable proof of deliberately misleading investors for a suit to truly succeed. Simply knowing that something bad is happening in the clinic, and not making any statement - good or bad - to anyone about a blinded trial for which the clinicians are responsible, is not malfeasance. Ethically, a trial with high AEs must be ended, but the AEs have not only to occur but be recognized as such in the clinic. How a company would give guidance about ending a trial before AEs were reported by the clinic is not clear to me.
I have no knowledge of the securities case mentioned in previous postings. We could all see that something completely without precedent was happening during the entire trading day on October 8, and it was probably not because it was a Tuesday with a waxing crescent moon. A charge of insider trading would be (very) bad for any individual, but would it result in a liability for the company?
I have not read the 10k, but the excerpts posted on this BB look like business as usual to me. If there were any mention of lack of working capital, that would be a real worry. The lawsuits are a nuisance - a big one to be sure - but that is all they are.
Would love to see a few more of these in the press as we go into ASCO in a few weeks....
Active trials and recruiting cost money - so that is a partial answer to your question.
As for re-starting the suspended trials? I would rate that lower priority than getting new ones going. The data from the suspended trials is not going to go away, and I assume that the patients that were in those trials would still be tracked for disease progression and AEs, at least for a little while, so there is still some work that could be done on that data - e.g. does/regime adjustment. With that data fully crunched, dosing and regimes changed (or not) then re-starting the suspended trials would generate useful data. Meanwhile - get some new stuff into the clinic!
JMTUO (just my totally uninformed opinion)