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Maybe you should read about options expiration
and triple witching.
the volume this a.m. has NOTHING to do with anything other than options expiration.
Pazdur is a crook.
One of the biggest pieces of trash in government.
I am saying that they had AP23573 (Defo-Rida) in Phase 2 studies at roughly the same time Wyeth and Novartis had their mTORs in Phase 2 studies.
Ariad, fell way behind because they screwed around with trial design and had to run a Phase 2b study converting the trial over from IV to tablet form. This cost them around 2 years...essentially the 2 years they are now behind with their mTOR (rida).
Regardless of their cash situation being improved, just because they got an infusion of $70 million HARDLY means they are in fabulous shape financially. A pivotal 534 study is going to cost $30 - 40 million. Dough, a '534 trial may be "easy" to design, but it's not INEXPENSIVE. Then, they are going to need to spend another (at least $10-15 million on '113 in the next year)...believe me, Ariad has NO problem spending as much money as they can. At this time next year, we are going to be talking about Ariad being in a precarious position of around $20 million in cash in the bank (assuming no partnership or no Rida payments - yes, you need to assume that Rida trial will not succeed when planning for cash).
I have zero use for Ariad to be in the same position they have been in for the past 2 years - being low on cash, and having investors avoid it like the plague and having the auditors issue a going concern letter.
Harvey-----SIGN A DAMN '534 DEAL AND LEAVE YOUR EGO AT THE DOOR.
They need to partner to:
1. Free up money for '113
2. So shareholders are still waiting for a Phase 2 study in solid tumors 2 years from now. GET IT DONE NOW!!!!
Why did FIDO buy so much? I don't know. They also own a lot of EXEL and a lot of other biotechs. It's certainly not Ariad specific.
They need to partner '534
I don't care about their current finances. It's about the personnel they have and the decisions they make.
Just because they have co-run a Phase 3, if they decide to go a pivotal trial in '534 they will just mess it up.
Harvey's ego. Never a doubt how badly he can screw things up. If this company had a real management team, Rida would have been approved in 2008, and they would have already had solid tumor P1 data for '534.
Good data is by no means a "free pass" to success
Take a look at Curis (CRIS) today. They have had many positive indications with GDC-449 (Hedgehog inhibitor). However, when it came to a RANDOMIZED trial, the drug flunked the text, big-time. CRIS was down 50% today (and could very well happen with ARIA - I suggest PUTS against your positions FWIW)
Word to the wise to those here who claim Ridaforolimus is a sure thing because it had good data in a Phase 2 *UN-RANDOMIZED* trial.
All bets are off when you blind and randomize.
Which is why SUCCEED trial is nothing more than a 50/50 gamble.
Chart beginning to look good here.
Can you explain to me why you have to post the daily price (as if most investors don't already know it).
Don't you have anything of substance?
This is a classic post.
I cannot believe someone put forth that much effort to make a post like this on a public message board.
That being said, it is a GREAT READ.
You could compile ALL the posts on Yahoo, and delete them...and just use that post for the entire Yahoo! ARIA board, and that's all you would need to know about the potential of Ariad.
Sums it up greatly, and even acknowledges that Ariad Management is the weakest part of the equation.
Re-evaluating my position here
Do not trust this management team and their constant pumping of this drug.
It clearly doesn't work in the cancers they continue to pump to investors.
It's clear that CRIS "ligand-driven" approach
will be a failure.
This company could have the worst management team in the world for giving the drug away for less than 10% royalties. Seems like BCC is the only hope going for this company.
I bought CRIS based on the results of their trials in BCC but this result is making me re-evaluate this company.
There's a reason why it is such a low price, low market cap company.
Perhaps it's because their hedgehog pathway drug is garbage....
Too bad....
Study is a failure.
Makes me want to re-evaluate this company.
Beware of sell-side research, FYI.
Most of the analysts said Provenge would fail, as would Benlysta.
I agree.
In fact, I am not here not because of their near-term drug candidate Ridaforolimus (the weakest of their products). mTOR is a relatively old compound, and there are much greater potential drugs out there which target a cascade of targets (ie. mTOR/AKT/PI3k) in combination. mTOR as a single agent has been clinically proven to produce feedback loops which make the drug less effective. I think Merck owns the compound now because they are merely interested in it working in combination with their other compounds (like the DALO study). mTOR is much more likely to be effective combined with these types of compounds (to hit multiple targets, and not just single out mTOR). SUCCEED trial is nothing more than a 50/50 gamble at this point in sarcoma. If it was a knock-out success, the trial would have been stopped by now (despite the efforts of some to describe the FDA as being more 'vigilant' and making trials last til the end)(they certainly didn't do that with the other 2 mTORs approved).
I am here on a GAMBLE that Rida works in SUCCEED. My gamble has a "put" in it with '534 and '113. '534 is where the real money is; and its the real driver for this company.
IMO
I just searched this board and wasn't able to find one instance of a post containing the term "$65"
When anyone uses the term "poison pill", it's safe to say they're speaking of "$65".
As far "palifosfamide + doxorubicin", having "longer PFS and improved patient stability", wasn't this what Ridaforolimus was originally for?
Perhaps Ariad management should have been smart enough to use Rida in combination with another drug for their Phase 3 study. Instead, they didn't have the money, nor the expertise, to figure this out early on with Defor (Rida), so, now, they are stuck with a single-agent mTOR in Phase 3 which is a lot less likely to work than with a combination.
So what you're saying is if the ZIOP study shows greater efficacy in the maintainence setting, than the SUCCEED trial, this will somehow help Ariad?
Unblinding colon study
Anyone know when this will happen.
What were the Phase 1 results of this study?
Any chance he can share more than what we know about the 2nd interim?
Answer: probably not likely.
I am not sure if either Merck or Ariad is allowed to see the results. Likely has to be written as part of the SPA.
Dendreon was allowed to look at their interim numbers (which essentially made investing in the company a layup considering the interim numbers showed positive efficacy).
FDA are crooks, IMO.
I would be SHOCKED if the FDA made Ariad go through a full trial (12 - 18 months) for '534. The drug CLEARLY works, and it would be criminal not to let patients have the drug. I truly believe this is another aspect of partnering: you need big partners because they have high influence in cutting through the bogus garbage the FDA pawns down on many small biotechs (without influence).
ARIA is not worth $7.8 billion
The company has:
1. Intellectual Property (which the patent was essentially invalidated and I am not sure it's worth much anymore - like most patents that came out of the Genomics Project)
2. Ridaforolimus (an mTOR which likely isn't going to earn much of a revenue stream in sarcoma due to several other compounds in the clinic which are for the sarcoma indication - one being ZIOP's compound. Other GIST compounds are showing great promise). I am not sure how much money Rida will bring in with combination - either way, those are likely 2-3 years away before any final approval (combo studies). The SUCCEED trial isn't a sure thing, either. The only value in Rida is it VALIDATES a compound Ariad has made in its own clinic.
3. '534. That's the big winner here.
4. '113. Likely won't see any revenues from dosing patients (assuming it's even approved, for at least 3-5 years - earliest).
How some people come up with all these being worth $7.8 billion (when Dendreon and Human Genome Sciences aren't even remotely worth that much) is beyond me.
IMO, this company is a buyout in the range of $1.5 billion-$2 billion assuming everything goes right. That would make it $15-20 fully diluted. More dilutions, less price. It's simple math.
DISCLOSURE: I am long. Reasons: 50/50 gamble SUCCEED trial succeeds. '534 partnership and I see the real value with what they are going to do with '534. '113 is still vapor, although, a valid target. All three of the above are reasons why a successful pharma would want Ariad - but no Board is going to approve a $7 billion buyout of the company, considering it's value today is roughly $400 million.
I agree 100% with you regarding Ariad "needing" to partner '534.
They don't "need" to for monetary purposes. They "need" to for all the other reasons that come along with having a large bio-pharma sponsor. Clinical trial expertise, funding combo studies, clinical trial designs, collaborations between smaller company and larger company, etc., and, of course, money.
Ariad has a much stronger balance sheet with the Rida deal. Yes.
I do not care what others here (who have been shareholders for, gulp, 10-15 years?) say about 'not needing to partner'. They're right, they don't 'need to partner.' - But, it would be the responsible thing to do. It would rapidly increase the clinical trials, it would rapidly increase combo studies, and all the other reasons I have listed above. Ariad doesn't need to give away the far in the U.S.
IMO, I think an equity stake from a large pharma would be a great idea. The problem is this: the current stock price. I don't want my shares diluted at these levels. $8-$10/share equity investment - go right ahead!!! It's MUCH better than giving it to the swines at BVF and Orbimed who only want to make money and play games (like shorting etc.) into equity investments.
Why I own Curis (CRIS)
Plain and simple. You can't lie about this data:
http://content.nejm.org/cgi/content/full/361/12/1164/F2
Just listened to the JEFF call again...
Don, Harvey did say this was a breast cancer patient, with a liver metasisis. The scan they showed in the presenation showed a huge mass with a dramatic suppression after 2 doses.
It was very impressive indeed
By the way, DALO + RIDA
I don't know if you guys saw the slide presentation of the ( believe Harvey said) "liver" MET in the JEFF conference.
Pretty impressive. That was a very large mass, after treatment, it dramatically shrunk.
OK...
Thanks.
But, to answer your question:
"Not sure where your getting your numbers from but just yesterday Harvey reiterated projected cash at FYE of around $46mm"
Those numbers are fine. But, look at it this way. What were ALL the analysts saying in April about Ariad's ~$40 million cash position? They were saying the company needed financing.
We will be in the same exact position next April with cash right around those levels if they do not receive funding.
All I am saying is I think this "go it alone" mentality is a thing of the yester-year for biotech. It makes sense, IMO, to partner, and have large pharma "hold your hand" for a piece of the money.
What has been the rhetoric from Harvey,
in regards to a '534 partnership? I know in the past he has said (as far back as a year ago), they are actively looking for a partner.
"In reality the balance sheet has never looked better with funding sufficient into 2H11"
I disagree. Assuming the capital markets continue to be volatile, I do not want to see my stock diluted (again) at these levels. Around the 1st quarter of next year, if Ariad has not received funding and if the SUCCEED trial is a negative, investors are going to be focused on one thing and one thing alone: funding. The albatross on Ariad's neck for the past 2 years has been funding. I am sick and tired of it....and I think the recent Merck re-neg lessens that and gives us more time.
I would think that $80 million would be enough for a lot of stuff now that Merck has all the costs of Rida going forward, but it seems like Harvey is stating they are going to blow through that very quickly.
I want to be in a very viable position. A position of having a couple hundred million dollars: 1. For '113 quick advancement (I think if Ariad had money last year, we would already have an IND), and 2. For full funding of '534 in AML and solid tumors (something Harvey said would be happening 2 years ago - that is, starting trials in solid tumors).
I want to see them sign a deal worth $100 million for '534 ex-USA sales. Incyte and other companies have signed deals similar, I do not see why Ariad cannot.
Question about Pivatol '534 trial
Ariad has the finances to "probably" scrape through what they have in cash ~$80 million, to finance a final '534 trial.
What are your thoughts (Don) on a partnership and when such partnership, if and when, would take place.
Personally, I think that a '534 end-stage trial should have input (and backing) from a large pharma. It is just easier for Ariad being a small, underfunded and undercapitalized firm. Also, you get incredible knowledge from large pharma who has already done hundreds of these FDA trials. Ariad, has only done a handful, and only ONE P3 trial.
A partnership also gives them leverage to expand into solid tumors quickly and AML. Ariad does not have the cash to push all these, and '113 into trials alone.
Thoughts?