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Having been the CEO of two companies, I sincerely hope you are wrong. If he has the time or inclination to read a message board then we are in a lot of trouble.
seriously? you think the ceo reads this message board? since the vast majority of posts lately are focused on short-term intra-day moves, and Berger hasn't ever sold any shares, my guess is that he's only slightly less interested than I am.
So, basically, you want to buy low and sell high. Thanks. Got it.
Please disregard my comments from earlier this morning, lol. clearly I was mistaken. carry on!
Do I think ARIA is close to being fully valued "today"? Yes (see post 6647), however, that being said, I'm not taking profits at this time because, imo, today's valuation does not reflect the value of AP113 and I think AP113 is a big piece of Ariad's potential upside. Of course, if your time horizon is measured in days or weeks then you may not be willing to wait for the next big leg up, however, selling out now, before we even get to P1 seems a bit premature ;)
With gleevec coming off patent, the real concern is what's going to happen to margins in 2015. A CBO study conducted a few years back found that generic's reduce profit margins by an average of 12%.
Nope, just enjoying the ride!
BRAF mutations are my top choice as well. Sorafenib failed to improve survival precisely because it did not target the mutated form of BRAF present in about 60% of malignant melanomas. In addition to 60% of melanomas, BRAF mutations are found in almost half of thyroid cancers and in about 10 to 15% of ovarian and colorectal cancers. I don't know if this is something Ariad is working on but targeting BRAF mutations clearly represents a huge opportunity.
EGFR mutations are most commonly found in patients who have never smoked. In the US of the approximately 220,000 patients who are diagnosed with lung cancer each year, about 10%-15%, or 20,000 to 30,000 are never smokers. Of these, around 40% express egfr so my best guess is that around 8,000 to 12,000 patients in the US have the mutation.
With over 1 million deaths worldwide from lung cancer. obviously, the number is higher worldwide. Also, the non-US numbers may be much higher as the egfr mutation is most common in non-smoking, asian women.
Peter, given that Gleevec has shown little benefit for high risk pts (Nature 2005), I think your view that this patient population represents the best opportunity to move ponatnib to 1st line is right on the mark. Using Sokal criteria, this could represent anywhere from 10% to 18% of newly diagnosed CML pts in the US and up to 30% of pts internationally. (see "Risk Stratification of Patients of Chronic Myeloid Leukemia According to Sokal Criteria")
btw, do you know of any trials that have been run comparing tasigna or sprycel to gleevec in high risk pts?
Other than a vague reference to "other molecules in our pipeline" in response to an analyst question earlier this year, I don't believe the company has given any guidance or timeline for a 4th compound.
AP113 may very well end up being Ariads first billion dollar molecule.
Then please explain why Affinitor had a HIGHER percentage of deaths in it's trial arn than Rida. Despite your postings to the contrary, any reasonable analysis would conclude the AE's are class related and not Rida specific.
Yeah, that is too low, imo. $205mm is only about a quarter of what tasigna and sprycel are doing in 2nd line today. Of course, if she went any higher she'd also have to raise her price target as well, lol.
I believe the pdufa rates can be found here
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm
Dew, I had GHDX on my watch list most of 2010 but didn't end up taking a position until Sept/Oct.
As posted to the board last May, I found managements' initial explanation of a missed 2Q10 target to be somewhat suspect and I waited for a couple more quarters data on several new diagnostic tests they were launching. The company has now rolled out breast, colon and prostate tests and seems to be building a nice portfolio (also somewhat plays into your "tailwinds" theme).
Trading ideas are fine but that's different than posting your purchase and sale history to the board.
Bravo. please do keep us informed. perhaps it might be more convenient for you to just post your brokerage statement so we can all follow along.
My guess is they'll use the ponatinib "playbook" and initially go for 2nd line approval based on a pivotal P2 trial that could begin as early as late next year. Once approved (and generating revenue) they'll run the head to head trial needed to move to 1st line and hopefully capture a big piece of that $2.5 billion pie (although I have no idea where the analyst came up with that number).
Ironically, I thought the biggest news affecting Ariad yesterday was actually the Crizotinib data...really impressive. I saw that one analyst put the market opportunity at $2.5 billion. Although it is way too early to know, given the resistance data released earlier this year, this could potentially have greater commercial value for Ariad than ponatinib.
Sure, I read it the same way you did: a 2 month improvement in OS - from approx 20 to 22 months. Yesterday Ariad also confirmed the OS trend has continued to improve, so, in my mind, we are likely to achieve a statistically significant OS endpoint.
Well, the rida endometrial trial showed over 100% improvement in pts who achieved stable disease vs the control arm. The benefit has to be coming from somewhere, lol. Furthermore, the CBR that the majority of the pts in the everolimus trial was from....wait for it....achieving stable disease.
Also, your post to the contrary, rida appears to be far more tolerable in this setting than everolimus.
We'll have to wait a couple of weeks for the presentations but, given the OS trend, I believe the SUCCEED trial will meet its secondary endpoint as well.
The aml abstract confirmed that ponatinib is just as effective in aml as the current frontline treatments are in cml.
Posts on this board to the contrary, I found the endometrial results superior to those achieved in the everolimus trial (although the AE's in the separate endometrial trial show the current dose may not be tolerable in a very sick and elderly patient group).
All that said, however, it wouldn't surprise me if the stock initially trades off this morning. Apparently there are a lot of folks who just aren't willing to wait for the actually data needed to make an INFORMED decision.
So, BTH declares rida "garbage" and qutrader is going to sell all his stock this morning. Based on what? The OS data reported in the abstract is 6 to 8 months old and, yet, there was already a 2 month improvement in OS. My suggestion is that you come back in a couple of weeks when the cohort and updated OS data are actually available and I think we'll see what's garbage isn't the results.
"Ariad Could be Summer’s Breakout Biotech", lol, heck, Ariads been my "breakout" stock for a couple of years now but the more folks who continue to find the stock, the merrier.
With regard to Ariad, I don't think the "sell the news" strategy is the way to play ASCO this year. imo, very little of the recent gains are due to the anticipated positive Asco data but rather a reflection of 1) a reduction in the uncertainty associated with Merck filing the NDA and 2) increased recognition of the ponatinib opportunity, 3) validation of Ariads drug discovery capability and pipeline. How much of that is "baked" into todays price? At $9 or $10 bucks, my answer is "not enough".
true, it was a perfect storm...market crash on top of year end tax loss selling, very little liquidity, and then the directors fiasco...in hindsight I'm glad I held my nose and kept buying but at the time those purchases had a high pucker factor.
FAQ on CPP-115 now available from the company's website - http://www.catalystpharma.com/cpp115faq.htm
Ocular Safety Pilot Results (pdf)
Key Findings:
The long-term use of vigabatrin for the treatment of patients with epilepsy has been associated with
the development of visual field defects.
The short-term use of vigabatrin seems promising for treating cocaine and methamphetamine abuse. No visual field defects developed with short-term use in this pilot study.
No changes in acuity and no ocular adverse effects were
encountered.
http://www.catalystpharma.com/pdf/OcularSafety.pdf
Key Upcoming Dates/Milestones
May 18 - ASCO Abstracts available
June 3-7 ASCO 2011 (Rida presents data on endometrial, breast, and sarcoma/Ponatinib AML presentation)
July 3-7 14th Annual World Conference on Lung Cancer (AP113 update)
Rida NDA filing/$25mm milestone payment
New Rida P3 Trials (Endometrial (Rida), Breast (Rida+DALO)
AP113 Phase 1 trial start
Ponatinib reaches full enrollment (early Fall)
December 10-13 ASH (Ponatinib update)
Rida Approval
Ponatinib NDA
AP113 first interim data
rkrw, in light of recent research which indicates that pts develop resistance to crizotinib within a year, I'm wondering what type of AP113 P1 trial makes the most sense to you?
Here's what really caught my attention:
"We found that cells resistant to intermediate doses of crizotinib developed amplification of the EML4-ALK gene. Cells resistant to higher doses (1 µM) also developed a gatekeeper mutation, L1196M, within the kinase domain, ]rendering EML4-ALK insensitive to crizotinib
Fortunately, "this gatekeeper mutation was readily detected using a unique and highly sensitive allele-specific PCR assay."
I wonder how this will impact the AP113 trial design? It seems like the least risky approach would be to initially go for 2nd line and enroll only pts with the gatekeeper mutation.
A recently published abstract (see http://www.pnas.org/content/early/2011/04/11/1019559108.short ) found that despite "remarkable initial responses, cancers eventually develop resistance to crizotinib, usually within 1 y, thereby limiting the potential clinical benefit."
Just a thought but perhaps the AP113 start may be related to the design of the trial Ariad intends to run. If they follow the ponatinib playbook and initially pursue 2nd line treatment status for pts who initially fail crizotinib, they would have a relatively small pool of pts to draw from (the crizotinib phase 2 is only 400 pts and is still enrolling). http://www.clinicaltrials.gov/show/NCT00932451
Rida selected "Best Of ASCO"
Each year, an ASCO committee selects the abstracts that represent the "foremost research in oncology today." These abstracts are then highlighted for presentation and discussion at the Best of ASCO Meetings.
Check out the 1:45 PM – 2:30 PM time slot:
http://boa2011.asco.org/BestofASCOSEATTLE/MeetingProgram/ProgramAgenda.aspx
Sarcoma
William Tap, MD - University of Calfornia, Los Angeles
Abstract #10005: Results of the phase 3, placebo-controlled trial (SUCCEED) evaluating the mTOR inhibitor ridaforolimus (R) as maintenance therapy in advanced sarcoma patients (pts) following clinical benefit from prior standard cytotoxic chemotherapy (CT). (Sant P. Chawla, MD)
Not sure I understand your point...are you questioning targeted gene therapies in general or Ariad's ALK inhibitor specifically? As far as your comment that "the idea that there is a whole class of compounds whose path through the clinic is well predicted by in vitro or mouse models seems, well, rather optimistic", well, welcome to the 21st century.
Take CML, for example, which is caused by the BCR-ABL gene. The ABL gene is a signalling molecule and plays an important role in cell proliferation, however, in CML patients the ABL gene is always active and causes the continuous production of cml cells. It is this activity (and the various mutations that may result) which drugs like ponatinib are designed to target and, in general, if they work in vitro there is a much higher likelihood that they will also work in the clinic (as compared to drugs that do not target a specific gene or protein).
All the cohorts are expected to be fully enrolled by late August....Berger expects most/all cohorts to be oversubscribed.
The trial requires 6 months follow-up so we are looking at final analysis sometime in 1Q12. Berger stated that the data presented at ASH will be more than an "interim" look as many of the pts will have already reached the 6 month mark by then.
Precisely, the biomarkers should allow ariad to target those pts who have mutations that are not likely to respond to Pfizer's Crizotinib. Thanks for clearing up any confusion.