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I didn't hear USA only. I heard him say they were consider Asia and possibly Europe. To my knowledge that the first time Berger has indicated that not partnering EU was a possibility. Well at least that is the inference that I'm making.
I don't think there has been clear guidance in terms of scope or timing. Until JPM, I was under the impression that ARIA was considering deals in both Asia and EU. I may be mistaken but something he said at JPM left me with the impression that they may only do a deal Asia and keep both US and EU. Did anyone else pick up on that?
A lot of risk just got priced out of the stock yesterday but net net we're only up a buck. Anyone with more than a 3 month time horizon is going to make out fine. fwiw, my target is $8 going into ASCO, $10 by the time the rida NDA is filed and $12+ upon approval.
I think it's unlikely but if it happens at all it will be before the ASCO abstracts are released; after that there are a string of potential positive catalysts to consider:
Ponatinib partnering in Asia and/or EU
Start AP113 Phase 1 trial
New Phase 3 ridaforolimus trials
ASCO
First look at ponatinib data at ASH?
Ponatinib full enrollment
Filing rida NDA
Net of cash, WHRT has a market cap below $20mm. fwiw, I'm using the recent news regarding the 60 day delay to add to my position.
It's all good (hey, in the end we both were "right")
The 2011 ASCO filing deadline is Feb 2 but abstracts for randomized P3 trials for which preliminary data is not available by Feb 2 have until April 1. So, I definitely think they'll be presenting. Like you, I suspect some of the STS subgroups is going to be very positive.
fyi, the ARIA posts by biomaven, poorgradstudent and others going on over at biotech values is definitely worth checking out!
http://investorshub.advfn.com/boards/board.aspx?board_id=1418
Nice to see Jeffereys raise their target to $11 but with Oppenheimer at $8 and Barclays at $9, I think we'll be in for more upgrades once the difference between the independent review and the investigational sites is better explained. Irregardless, the trial clearly met it's primary endpoint and even though the placebo arm progressed after only 3 1/2 months, rida was still able to achieve a hazard ratio of .69-.72 which, imo, may bode well for the OS data.
btw, ASCO abstracts are usually available in May which should make the 2Q interesting.
The primary completion date occurred in October. The change in the "study completion date" simply means that the company expects to continue to collect data until June 2011.
Primary Completion Date
Definition: As specified in US Public Law 110-85, Title VIII, Section 801, with respect to an applicable clinical trial, the date that the final subject was examined or received an intervention for the purposes of final collection of data for the primary outcome, whether the clinical trial concluded according to the prespecified protocol or was terminated. A "Type" menu is also included, with options Anticipated and Actual. For active studies, set Type to Anticipated and specify the expected completion date, updating the date as needed over the course of the study. Upon study completion, change Type to Actual and update the date if necessary.
Study Completion Date
Definition: Final date on which data was (or is expected to be) collected. Use the Type menu (Anticipated/Actual) as described above.
landing??? I'm in seat 3A with my seatbelt securely fastened waiting for the control tower to give us clearance for takeoff. lol
"I guess you better hope that the SUCCEED trial has the majority of its patients NOT in the bone sarcoma category then."
A couple of points you may want to consider. First, the majority of bone sarcomas affect children who, unfortunately, are not eligible for the SUCCEED trial. Second, the most common soft tissue sarcomas are leiomyosarcoma and liposarcoma. To date rida has shown to be particularly efficacious in precisely the sarcomas that are most prevalent.
Yes, but that's an apples to oranges comparison as those trials were looking at the PFS at 6 months.
Sorry if I confused you and PGS. I wasn't aware that there was any other way to calculate the endpoint without comparing the difference in the two arms. But that aside, I would seriously like to know how you can simultaneously conclude that the PFS (just to be clear I mean the difference) is going to be "weeks" AND that the trial is likely (60%) to meet the 33% PFS endpoint. That would mean the placebo arm would have to be about what, 18 or 19 weeks? Sorry but given the final endpoint wasn't reached until Nov. I just don't see how you can reach that conclusion.
Oh, I see how it works. If the "clowns" agree with you then they are not really clowns? how convenient.
btw, for sake of argument let's assume that you and the Jefferies analyst are right and the PFS is weeks and not months. So that means what, 6 weeks? well if that's the case then achieving a 33% PFS is going to be damn near impossible given the final interim was reached in November. So, no, you can't say on one hand the PFS is only going to be "weeks" and at the same time give the trial a 60% chance of succeeding...the math just doesn't work.
Management will likely use this pop for a new secondary. fwiw, I'm moving to the sideline until after the next raise...but what a nice way to start the year.
nothing on this list jumps out at me...the first major conference of the year is AACR but that's not until April.
http://www.medical-events.com/medical-oncology-conferences.html
PGS, my intent wasn't to imply that a larger dose necessarily equates to a better drug only that the two drugs are different. To that end, my understanding is that unlike the other mTors, rida substitutes a phosphonate for the C40 hydroxyl which "may" allow it to bind FKBP12 at higher concentrations.
If it was Ariad's decision to make, the JPM conference would be my guess but since it's Merck's ballgame now, I don't have a clue.
fyi, the CFO just picked up shares at .94. however, the co. also just filed a shelf and recent sec filings indicate the need to raise at least $3mm in order to move their 2nd drug candidate CPP-115 to clinical trials so any move to the upside may be capped by upcoming dilution.
Long-term I see this company being bought out by Lundbeck in order to protect their $900 million investment in the antiepileptic drug Sabril (Lundbeck bought Ovation in 2009)
30% to 50% of pts eventually become resistant to sprycel or tasigna - both of which are moving to the first line. Given the recent ASH data, Ponatinib should become the defacto 2nd line treatment option for those pts in addition to eventually moving to 1st line in high risk pts. Combined sprycel and tasigna have around $800mm in revenue so, yes, imo, Ariad has significant upside from current levels.
Of the CP pts who progressed, I believe the majority were receiving 15mg or less.
My understanding from yesterday's call is that worldwide about 25% of CML pts are considered high risk while in the US it's about 10% (i'm not sure what accounts for the difference). If ariad pursues first line in high risk pts, this does raise an interesting issue regarding their proposed strategy of keeping the US rights and partnering what could arguably be a much larger opportunity.
What I find truly remarkable is that 83% of the CP pts in the 45mg cohort achieved a MCyR. If these results hold up in the PACE trial, Ponatinib is clearly best-in-class.
This the exact same argument you tried to make back in July.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=52207138&txt2
I'm partial to Tor-ridador, myself, lol.
Let me get this straight, you are complaining because the ceo didn't pump the stock enough for you???
Also, how can you claim that the stock offering could have been done at $4.50 (20% higher) while simultaneously claiming that the underwriters had a hard time getting the deal done at $3.70? Get real.
Gee, all this proves is that leiomyosarcomas respond well to chemo....which is precisely what I told you a couple of days ago. So, no, I'm not "really disturbed" by your "new" finding, lol.