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Put a negative spin on it if you want but it still doesn't change the fact that rida doubled the PFS vs SOC....and it puts another hole in the single-agent MTors don't work argument you keep trying to make. btw, endometrial is a much larger market (35k vs 15k U.S. I believe) than sarcoma.
Oh, so you think the feedback loop is only active in Sarcoma? Not according to the very article YOU posted today.
On one hand BTH claims that Afinitor is "a "best in class" billion dollar compound" and the very next day posts about the "limitations of mTORs and the "limited" efficacy they show". Can't have it both ways, BTH, so which is it?
Quarterly conference call at 8:30 a.m. (ET) on Tuesday, November 9, 2010. A press release will be issued prior to the conference call.
The live webcast can be accessed at http://investor.ariad.com. The call can be accessed by dialing 866-362-4831 (domestic) or 617-597-5347 (international) five minutes prior to the start time and providing the pass code 60708669.
Looks like Ayer Capital just took a 6.81% stake. Nice to see more institutions coming on board.
Conference Call
The Company will host a conference call today to discuss the CPP-115 study results.
Time: 8:30 am ET
Dial-in numbers: (866) 501-1521 (U.S. and Canada) or (760) 536-8586 (international)
Conference ID#: 22090693
Live webcast: www.catalystpharma.com, under "Events"
The teleconference replay will be available three hours after completion through November 5, 2010 at (800) 642-1687 (U.S. and Canada) and (706) 645-9291 (international). The replay pass code is 22090693. The archived webcast will be available for one year.
CPP-115 demonstrates a major improvement in visual safety compared to vigabatrin.
"Based on the strength of this and the other data found in these safety and efficacy studies, the company considers CPP-115 to be the leading candidate as a next generation treatment for addiction and epilepsy. We expect to initiate the remaining studies necessary to file an IND in the third quarter of next year."
http://finance.yahoo.com/news/Catalyst-Pharmaceutical-pz-1812793254.html?x=0&.v=1
This is the third time you've posted the same article trying to claim that the "SUCCEED is an "all comers" trial....all sarcomas are being thrown into the bucket..." However, repeating something again and again doesn't make it any more true.
I'll try to make this simple. 1) Not all sarcoma's respond equally to chemotherapy. 2) Patients with sarcomas that do respond to chemo were much more likely to end up in the P3 trial. 3) Consequently, the premise underlying your "pick one" "50/50" argument is fundamentally flawed. I hope this puts this canard to rest.
ps have you figured out which of the sarcoma subtypes respond best to chemo yet? Here's a clue for you, they just happen to be the same ones, like leiomyosarcomas, that had the higher response rates in the P2 but I'm sure that was just a coincidence and wasn't factored into the P3 trial design at all....yeah, right.
I completely agree. BTH's continued posts that the trial is not going well simply because it wasn't stopped at the second interim is just another bogus argument. The negative does not prove the positive.
Thanks, Dew. In the second line sprycel and tasigna are generating just under a billion dollars. Approximately 50% of pts develop resistance so we are looking at initially a $500+ mm opportunity. In addition, I think it's likely that ponatinib will eventually be approved in a first-line setting for pts with the T315I mutation.
With sprycel and tasigna moving to first-line, I think ariad made the right decision in not partnering ponatinib at this time. While some on this board insist the company should partner now and start global head to head, multi-arm trials, I disagree. That kind of trial would likely require several thousand pts and could easily take 3 years or more, which is right about the time gleevec is coming off patent. As of today, I'd much rather own 100% of the 2nd line plus T315I opportunity than 50% of a first-line market that is only going to get more competitive.
Despite your continued insistence that it's a 50/50 gamble, I hardly think MRK and ARIA invested hundreds of millions of dollars, and Berger $3 million personally, on a complete "gamble". Not hardly. While the placebo group is most certainly progressing more slowly than the historical P2 data would suggest (which is not surprising given that the P3 pts were disease stable at the time of enrollment), that doesn't mean that the trial is any less likely meet its endpoint only that the trial is likely to take longer meet its endpoint, which it apparently is. You make it sound as if it's an either or situation when it's much more likely a combination of the two - the placebo arm is progressing more slowly AND the rida arm is working as designed:
"The data from the overall survival analysis of the Phase 2 trial further support our Phase 3 trial design and strategy, which focuses on metastatic sarcoma patients . We believe this well-defined patient population has the greatest likelihood of achieving sustained clinical benefit from treatment with a new molecularly targeted agent such as AP23573."
btw, what GNVC and NVLT did or didn't do has no bearing what so ever.
I never said either thing but please prove me wrong. Show me where I said "SUCCEED will not fail". I mean you put it in quotes so surely you can provide a link to the post. Where is it?
I'm not sure what you are talking about - the company said it's interested in regional partnerships just not a global deal. And yes I think Harvey has the skills needed to market a 2nd/3rd line drug in a well established market such as CML.
If Rida meets its endpoint, the company won't need the $'s.
The stock has been on a tear since the financing was announced...up almost 40%. fyi, the 20dma just crossed the 50dma...from a technical standpoint we don't hit resistance until 3.05.
The only "score" I keep is the value of my portfolio.
Sorry to disagree but, imo, the financing decision says almost very little about "Harvey's confidence in Ridaforolimus in the SUCCEED trial." Ariad can't stop developing 534 AND 113 waiting for the Rida results. Rida is in Mercks hands and, given the delay, the company was faced with the choice to partner 534 now or raise $'s. Time will tell but I think they made the right choice. I just feel kind of stupid for not seeing this earlier.
It seems a lot of us were caught off guard by today's announcement...myself included. However, upon reflection, I'm not sure this was all that unexpected. This summer, when Harvey transferred responsibility for the 534 partnership discussions, should have been a big clue that he wasn't going to seek a global development deal.
I always felt it was the company's intention to wait on the Rida final analysis and the $65 in milestone payments that would quickly follow NDA filings. However, with those results now pushed out several months, today's financing actually makes sense. It was either a secondary or a 534 partnership and Harvey has now made his intentions clear. Given the increased life expectancy of CML pts and the 30-50% who become resistant to current second-line treatment, I happen to like the decision to keep 100% of 534 even at the expense of today's announced dilution. How the market reacts tomorrow is entirely different matter but I, for one, will be glad the company owns 100% of 534 when the first data for pts with the T315I mutation is released.
Uhhhh, do you mean like "Targeting the PI3K/Akt/mTOR pathway: Effective combinations and clinical considerations"?
http://kitto.cm.utexas.edu/courses/ch395g/fall2009/MOL190/LoPiccolo.pdf
Yes, combination therapy looks very promising, however, your continued insistence that mTor's won't work as stand alone therapy has already been disproved. Knowing a feedback loop potentially exists and designing an effective treatment for a specific type of cancer are two entirely separate things. Personally, I think the evidence shows that there is a role for both mTors and more targeted therapies.
I heard the same comments at 1.50, 2.00, 2.50, 3.00, 3.50, and now $4. Exactly what part of +70% YTD is so hard to understand?
Lagging compared to what? ARIA is up 70% YTD and has significantly outperformed every biotech index out there including the BTK which is up 22% YTD. I think you need a new dictionary.
Well, anything is "possible" but the trial size hardly makes it likely.
btw, have you figured out which of the sarcoma subtypes respond well to chemo yet?
hmmmm, you seem to be missing the whole point for the design of the phase 3 trial. By selecting disease stable patients who have responded favorably to chemo, the trial in essence self-selects those patients that are most likely to respond to rida. You're criticism may have been appropriate for the phase 2 trial but it simply doesn't hold water, imo, for the phase 3.
Dig a little deeper and I think you'll find that the sarcomas that are most likely to respond to chemo match up well with the rida response achieved in the phase 2. The info is out there but , just as you stated to another poster, "I will not do your homework for you."
New Board Surveys! Four new surveys are up covering a variety of topics. Please share your opinion on the likelihood of an AP534 partnership; whether ridaforolimus will meet its primary endpoint; the possibility of a secondary financing in the next quarter; or if AP534 will meet its endpoint early.
Take the Surveys here: http://investorshub.advfn.com/boards/board_surveymenu.asp?board_id=2047
Oh, so your "analysis" is based completely on anecdotal evidence...that's just lovely. and, btw, who said anything about a guarantee...this is biotech investing, right.
My issue with your comments are the unsubstantiated claim that the CEO 'knows" something and it's baaaaaaddddddd. Spreading fear, uncertainty and doubt without any proof doesn't sit well with me.
uhmmmm, yes, of course anything is "possible" but your comments hardly rise above the level of pure conjecture. The only known fact is that the data monitoring committee recommended the trial "continue to its final analysis, without modification to the study protocol."
And which do you think is more likely an unneeded secondary or a 534 partnership?
Oh boy, your logic is flawed on so many levels that I just don't know where to begin. First, what does an RCC trial have to do with Sarcoma...not only are they completely different diseases but the two trials had completely different patient populations which makes drawing any conclusion between the two downright silly...apples and oranges, imo. Second, I suggest you check out the everolimus' P2 sarcoma results - everolimus had about a 50% lower PFS when compared to rida's P2 results. The fact that the DMC greenlighted the second interim results indicates that the arms are diverging otherwise the trial would have stopped. The simplest explanation is that a disease stable population is likely to take longer to diverge, again, imo, this is not unexpected. Finally, you've made the claim about Harvey knowing something and "hedging". Any proof or is this just pure conjecture on your part. Since YOU are the one making the claim, its up to YOU to support it.