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I know the company has been guiding for approval in the 1Q13 so that would certainly be an upside surprise. When an NDA is filed, the FDA has 60 days to decide whether to accept it for review(and 45 days to accept a company’s request for a priority review) so that puts us into the middle of Nov. However, it's certainly possible we'll hear sooner than that (based on the July 30 rolling submission).
Ponatinib clearly meets the standard for accelerated approval which could further reduce the timeline by an additional 3-4 months over a standard review. http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm
I don't think there's a live stream available but then again I probably wouldn't have got up at 5:15am on Sat anyway, lol.
ARIAD Completes Rolling Submission of New Drug Application for Ponatinib to the U.S. Food and Drug Administration
ARIAD Completes Rolling Submission of New Drug Application for Ponatinib to the U.S. Food and Drug Administration
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 27, 2012-- ARIAD Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced it has completed the rolling submission of the New Drug Application (NDA) for its investigational BCR-ABL inhibitor, ponatinib, to the U.S. Food and Drug Administration (FDA). ARIAD provided the FDA with remaining chemistry, manufacturing, and controls (CMC) data. ARIAD is seeking U.S. marketing approval of ponatinib in patients with resistant or intolerant chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). The Company has requested accelerated approval and a priority review of the ponatinib application by the FDA.
“In late July, we submitted the NDA for ponatinib ahead of schedule and, at the request of the FDA, in advance of having the final CMC data. We look forward to continuing our progress towards making ponatinib available to patients with CML and Ph+ ALL,” stated Harvey J. Berger, M.D., chairman and chief executive officer of ARIAD. “If approved, we believe that ponatinib will become an important new medicine for CML and Ph+ ALL patients who have become resistant or intolerant to prior tyrosine kinase inhibitor therapy.”
ARIAD anticipates approval and commercial launch of ponatinib in the U.S. in the first quarter of 2013. Also, the Marketing Authorization Application (MAA) for ponatinib, submitted in August, has been validated by the European Medicines Agency (EMA), commencing their review of the application. The Committee for Medicinal Products for Human Use (CHMP) has granted ARIAD’s request for accelerated assessment of the MAA.
http://phx.corporate-ir.net/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=1739175&highlight=
Well, back in November you thought the company was way "overvalued" at 1.5 billion ($11). In April. you were "disappointed" when the stock was trading at $15. In June, when the stock was trading at $18, you said the stock was "going down quickly". You are the best contrarian indicator this board has so by all means sell away.
PS I think you may have the wrong screen name, ariafan.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=69070271
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=77390525
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=74268141
Exactly. As long as the results show a strong RR in ALK+ and a relatively clean safety profile, I could care less about where the stock trades next week or, for that matter, the next option expiration. Unlike some , I'm not expecting EGFR results this weekend, in fact I'd be surprised if they've even reached the DLT. The next major leg up is going to be driven by the 113 cohort data and ponantinibs approval.
apparently the machines got upset when the MolecularMD test was deemed unnecessary
--------------
Diagnostic Withdrawal Created Weakness in ARIA and an Opportunity for Investors
By Jake King
Shares of ARIAD Pharmaceuticals (NASDAQ:ARIA) have been moving sporadically in the last week as traders test the limits of its latest range; ARIA set a new 52-week high last Wednesday and again on Tuesday – at $24.05 – but subsequently closed the day weak, at $23.18. On Wednesday morning, the stock is off by 2% in premarket trading, to $22.78. After delivering consistently higher-highs and higher-lows in the last two months, a very bullish trend, ARIA appears to be pulling back slightly since its recent impressive performance.
The hesitancy began on the 19th, when the company reported that Molecular MD, a private molecular diagnostics firm, was voluntarily withdrawing a Premarketing Approval application (PMA) to the FDA for its BCR-ABL T315I mutation test, a test that would have been used as a companion product to ARIAD’s lead candidate ponatinib. The ARIAD drug is under review by the FDA as a treatment for resistant or intolerant Chronic Myeloid Leukemia (CML) and Ph+ acute lymphoblastic leukemia (Ph+ ALL) and demonstrated positive results in clinical testing. The FDA informed Molecular MD that the diagnostic was no longer considered a companion product to ponatinib because the test must provide essential information for the safe use of a therapeutic product.
The news is less dire than it first seemed. The FDA deemed the T315I test unessential for safe diagnosis and treatment with ponatinib not for safety concerns, but simply simply because it is unnecessary. The diagnostic was used in clinical trials for ponatanib’s development to identify patients with the T315I mutation, however, the test is not required for the FDA to approve ponatinib. Early adopters will still have the ability to identify target patients as other tests exist that enable physicians to get this information and treat patients accordingly. Analysts have stated that the rejection of Molecular MD’s test is a “non-event”, and that they still expect a major pharmaceutical company to partner the drug in the coming months.
The final verdict? ARIAD still has a potential blockbuster in the approval process and two more promising drugs in the pipeline. Management expects an approval early next year with a commercial launch following shortly after. Now that we’ve seen where ARIAD can go, this may be a good time to buy into a company with real opportunity in the oncology space.
Update: ARIAD initiated the Phase III EPIC trial of ponatinib for treatment naive CML patients on Wednesday morning, which should help strengthen the stock.
http://www.propthink.com/diagnostic-withdrawal-created-weakness-in-aria-and-an-opportunity-for-investors/2291
He's just a shill for the machines, lol.
lol, I don't think the machines realize just how big the potential front-line opportunity is for ponantinib. In a 3/4 line setting 30% of chronic-phase patients taking ponatinib were able to achieve a major molecular response in less than 12 months (10.1). In a third-line setting, sprycel and tasigna only achieved around a 20% MMR. However, moving from a 3rd to a 1st line setting, the MMR rate for sprycel/tasigna more than doubled to 43-45%.
The ponatinib EPIC trial is powered to detect a 49% MMR at 12 months...personally, I'd be very surprised if we don't exceed that by a significant margin.
http://bloodjournal.hematologylibrary.org/content/114/20/4361.full
http://bloodjournal.hematologylibrary.org/content/114/20/4361/T3.expansion.html
fwiw, i exited CPRX on the recent run-up. If CPP-109's results meet the trials endpoint, the company will likely find a partner on decent terms. However, given the under-capitalization, any misstep is going to be near fatal. Consequently the CPP-109 read-out is a binary event that I'm sitting out. I remain interested in CPP-115 but it is just entering human trials and doesn't provide a sufficient safety net to warrant holding through the upcoming, albeit delayed, news.
that's because the "machines" don't "know what they own"
Too esoteric? I thought "Animal House" was a metaphor for the overall market while, in the clip, Kevin Bacon plays the part of an ARIA short, lol.
ding. ding. ding. I think we may have a winner.
Thx. From the recent ASCO abstract we know that for LDK378 "The overall response rate was 81% among the 26 patients previously treated with crizotinib who then received LDK378 at doses of 400 mg per day or greater. The objective response rate among all 33 patients with NSCLC receiving at least 400 mg per day was 67%."
Digging a little deeper, we know from the above that 26 pts (78.8%) had failed crizotinib which means that 7 (21.2%) of patients were treatment naive. While the crizotinib resistant group had a response rate of 81%, the overall response rate (in both naive and resistant pts)was only 67%. From this we can conclude that LDK378 appears to have a very low response rate (on the order of only 15%) in treatment naive patients.
26...78.8%...81%...63.8%
7....21.2%...15%....3.2%
---------------------
33....100%.........67%
Also, I'm very interested in AP113's response in treatment naive pts as compared to those who have failed crizotinb. This could end up being a real point of differentiation vis-a-vis LDK378.
Exactly. That's why the safety/ae profile in ALK+ pts being presented at ESMO is critical to understanding the ultimate potential AP113 has in EGFR.
Semantics, really? First, you run the trial. Second, you collect the data. THEN, you report the data. In biotech investing, I've found that everything else is mostly noise.
You're not going to have EGFR results until the company actually runs the egfr cohort of the trial.
I was responding to a question about the ESMO press release. I do not think the press release was referring to AP113 because, at this point, there are no EGFR "STUDY RESULTS." I do expect we'll get additional early "color" during the associated conf call.
Do you really expect AP113 "study results" in EGFR? I know i don't.
On second thought, I'm not sure if he was referring to crizotinib. However, considering that the trial has just entered its second phase, it's unlikely there is sufficient data at this point for him to be referring to AP113.
I believe he was referring to crizotinib.
There is no need to terminate their relationship...in fact the T315I mutation is still the fastest way ariad will get ponatinib to the front-line. todays news simply means the label will not require the test....all in all the best of both worlds.
today's news does provide some additional insight/expectation into how the FDA views ponatinib...which is a net positive.
She just issued an upgraded last week and, relatively to the share price, this news was, for the most part,already baked into the price as the market expected that ponatinib will be used beyond the T315I mutation.
The clock starts once the FDA accepts the NDA....waiting on the CMC section to be filed.
You seem unwilling/incapable of understanding that the phase 2 portion in the PHASE 1 TRIAL is not the PHASE 2 TRIAL. Your confusion was justified the first and second times but I've answered the same question from you 3 times now. The answer isn't going to change. I suggest if you are still confused you should re-listen to the cc again OR DIRECT YOUR QUESTION TO SOMEONE ELSE.
ONCE AGAIN, THE PHASE 2 CLACKSON WAS REFERRING TO WAS THE SECOND PHASE OF THE PHASE 1 TRIAL WHICH ARIAD IS NOT GOING TO AMEND INTO A PHASE 2 TRIAL. THEY ARE GOING TO RUN A SEPARATE PHASE 2/3 BEGINNING NEXT YEAR IN ONE OF MORE COHORTS. THIS WILL BE THE PHASE 2 TRIAL AND WILL LIKELY BE THE REGISTRATION TRIAL(s).
I'm done trying to explain this to you. Did we even listen to the same call?
Yes, that's what I heard.
fwiw, imo, the big takeaway from the call was the potential AP26113 has as a pan-inhibitor. The key is whether the safety profile for ALK+ pts will allow a dose high enough to also be effective in egfr....can't wait to see the upcoming data.
I stand by my original comment. I believe you may be confusing the second phase of the P1 with the phase 2 trial. I would suggest listening to the call at the 17:40, 18:18, 18:35 and 19:15 mark.
It's clear to me that a pivotal phase 2 registration trial in one (or more) of the 4 cohort groups will begin in 2013.
The P1 has TWO phases, a dosing/safety phase and then a "phase 2" consisting of four cohorts.
This should not be confused with the Phase 2 trial which, much like ponatinib, may well be a pivotal, registration trial.
My guess is the company will present the results from the phase 1 portion including MTD, DLT, AE's, response rates etc, but would be somewhat surprised if they present data for the second phase cohorts....although i would expect more detail will be made available at the scheduled conference call as well as during the upcoming research day.
The AP26113 trial is being conducted in two parts: an initial dose escalation phase in 30 to 50 patients...followed by an expansion phase in four cohorts of patients (20 patients per cohort, approximately 80 patients altogether).
Expansion cohort 3 consists of NSCLC patients whose tumors exhibit epidermal growth factor receptor (EGFR) activating mutations and who are resistant to at least one (1) prior EGFR inhibitor.
I agree it would have been sleazy if they failed to mention in the PR that the CMC section hadn't been filed yet but that's not what happened here. In this case, the CMC section is expected to be submitted within 60 days which is actually very timely considering that an analysis of the rolling review process conducted by the FDA found that typically "CMC sections could not be prepared significantly earlier than 3-6 months prior to the rest of the submission." (See http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm129264.htm )
Sure wish these damn trees would get out of the way, I'm having trouble seeing the forest :)
Andy - true, brain metastases occurs in 20-50% of pts (it's actually more common in small lung cancer than nsclc) but that doesn't necessarily mean that AP113 crosses the blood-brain barrier. If AP113 is as effective as we all hope, then you would naturally expect to find fewer pts with brain mets simply because the cancer is not progressing. I suspect that it's a somewhat circular, "which came first", situation.