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Hi BTH
I will accept your appology now :O)
Please forward same
Barry
Was there an extension?
If the completion date was changed from June 2014 to June 2011, was this an extension? Or was it designed to cut three years off the completion date.
Can it be that the original 2014 date was by design, just in case the primary endpoint was not met and the company wants to meet the secondary endpoint (OS) to have the drug approved.
Barry
Hey Poor
Whats your take on the date changes?
Any significance to whether or not Rida met it's primary
endpoint?
Rich
Help Scientists
Would some of you scientists please shed some light on the changing of the dates in the succeed trial.
It appears that Merck has extended the time in which to report the final results of the trial. Is this statement correct?
What may be some of the reasons for this action?
Does this action reveal. or give us any hints, as to the success or failure in meeting the primary endpoint of PFS?
Could it be that the primary endpont of PFS is very close to being met and that an additional period of time might be needed to meet that goal?
Could it be that the primary endpoint has been met in certain forms of sarcoma and addtional time may be needed for other forms to also meet the objective?
Please help me, and the other non-scientists, understand the significance of this action. That's, of course, if there is any significance at all.
Thanks, Barry
Perhaps
Perhaps this new credit facility was not as much about raising an additional 5 Million now, but extending the payment out by 2 1/2 years and freeing up the money that much longer, to use for clinical trials,
Perhaps
JMHO,
Barry
To a poor grad student
From an ex (but rich) grad student
We will know for sure, soon enough.
JMHO, Barry
THE MESSAGE
With all the emphasis that HB placed on Rida, I strongly believe that he was sending us a "message" that said to me....Rida will meet its endpoint in the succeed trial. I realize that some of my fellow posters came away with a different message, one that said.....not to worry about Rida failing to meet its endpoint in the succeed trial because Merck is behind it and will have it approved for another indication.
I guess each of you will have to decide which message HB was trying to convey to us, because one thing is certain (at least to me) Merck and HB know the results NOW.
As I previously said to BTH "We will know soon enough"
JMHO< Barry
Though I agree with you that the details of Phase 3 will be announced at a scientific conference, Merck may announce that they have filed a new drug application for Rida.
JMHO, Barry
It had to be more than 10% because of the following:
1- In the first agreement between Merck & Ariad, it was reported that Ariad would receive a "double digit" royalty on sales of Rida.
2- As part of the revised agreement, I recall Harv saying that Ariad's royalty would be increase by 5%
Therefore, 20% sounds both reasonable and plausible.
Barry
Thanks...But
Thanks for the response, but can you explain how Jeffreies can assign a 60% probability of success in the succeed trial and still report that the drug will more likely miss its primary endpoint?
Thanks, Barry
Scientists....Please Help
Can someone please expain how Jeffries can report that experts see a modest 6 weeks PFS for Rida (and ODAC wants to see at least 3 months) and yet assign a 60% probability of success in the Succeed trial?
Can a drug fail to meet its primary endpoint and still succeed if it meets its secondary endpoint?
Thanks,
Barry
The Ariad Annual Analyst's Award
Lets see who wins the award by coming closest to the actual closing price of Aria on December 30th 2011. No explanation necessary, just a single price.
My entry is $15.55
Barry
Hedge
You end your post by asking why don't I think that Afinitor is being tested in a single agent sarcoma phase 3 trial. You answer the question yourself in your opening remark.
Rather than going back and forth with our opposing views on the prospects of Rida meeting it's endpoints in the succeed trial, I suggest that we wait just a couple of weeks or so to get the definitive answer to that question. Then when the results come out, I will accept your appology :O)
Barry
CAUTION......DON'T SELL RIDAFOROLIMUS SHORT
It amazes me to see how many posters discuss Rida in such a "ho hum" fashion and believe that Rida does not have a very good chance of getting approved for sarcoma and has a slim to none chance of producing any meaningful revenue.
I disagree with these assessments and actually believe that Rida can be a blockbuster. I believe this for several reasons:
1- Affinitor
2- Multiple indications
3- Merck
The most logical means to assess a drugs sales prospects, is to use a similiar drug that has already been approved. In the case of Rida, we have a similiar drug that has already been approved and that drug is Affinitor (NVS). Like Rida, Affinitor is an MTOR inhibitor. Though it has only been approved for kidney cancer at present, Affinitor is also in the clinic in other indications, such as breast cancer. In the first 9 months of 2010, Affinitor (with only the kidney cancer approval) rang up 163 million, or an annual rate of 217 million. Experts are predicting that with other indications being approved, Affinitor will be a block buster with annual sales over one billion and some estimates running as high as 5 billion annually.
Rida, like Affinitor, is also a multi targeted drug, and as we here well know, is in the clinic for other indications (other than sarcoma) including breast cancer, endometrial cancer, prostate cancer etc.
Do these posters I referred to actually believe that Merck committed about $1,000,000,000.00 to a drug that simply may be the first drug in 20 years to treat sarcoma, and as some believe here, only has a 50/50 shot at meeting it's endpoint to serve that small market? I don't think so.
I CAUTION AGAIN..... DON'T SELL RIDAFOROLIMUS SHORT
Just yet another example of the "good science" at ariad. Science has finally advanced to the stage where Ariad's drug (AP1903) can now be used to do some good and I suspect this is not the only application we will see in the near future.
JMHO, Barry
It appears that I may be in the minority, but I am now increasing the % I am assigning to a successful outcome of the Rida Phase 111 to 75% success vs 25% failure for the following reasons:
1- The exceptional science at Ariad
2- The Phase 11 numbers
3- Merck (both their confidence in the drug and their experience in getting drugs approved)
4- The action in the stock over the past few weeks:
a) Steadily rising price
b) Rising volume
c) Apparent accumulation
I was previously at 60%/40%
As usual this is JMHO
Barry
The results are Blinded but not Blind
Though the results of the Succeed trial are blinded, and with all that is riding on these results by Aria, don't for one minute believe that Aria is blind to the progress, or lack thereof, of each patient in the trial. I am sure that the doctors in the trial report (even if not officially) the progress to either Merck and or Aria. Though they may not know which patient is on meds or placebo, they can certailnly make very educated guesses as to how the drug is working from how the patients are doing, as a group. This is why, I believe, that HB made the comment he did at the conclusion of the conference. I am aslo sure that his response to the question as to why his confidence, was mainly guided by his reluctance to divulge how the patients were progressing. That said, I am equally certain that some of his exuberance must have been based upon the Endo results, but I truly believe that my former explanation was more compelling. I can't for a moment, believe that HB would have said what he did at the conclusion of the conference, without very good and sound information. HB does not need any more egg on his face.
JMHO, Barry
Did I miss something???
I listened to the conference call and did not hear anything negative that should have casused the stock to drop as it did so far today. DID I MISS SOMETHING? If anyone herad something to account for the stocks movement today, please enlighten me
Barry
This is wonderful news for 534, and at the very least , confirms what Harv has been saying all year. Finally, Gleevec, Sprycel and Tasigna will go head to head in first line CML treatment, which means that 534 has a clearer path to 2nd line treatment. I am not a scientist, but it appears to me that if all three compete for first line then it creates a larger pie for a new 2nd line treatment drug (534) because if patients mutate on either Tasigna or Sprycel, 2nd line market expands. I would appreciate some feedback drom the scientists on the board as to whether what I said makes any sense, or am I just showing my scientific ignorance. I also remember that one of the scientists that created Gleevec, and was also involved in the phase 1 534 clinical trial, stated that 534 was ten (10) times more potent than Gleevec. I also recall another Dr., who was involved in the 534 trial,and is one of the leading CML treating physician and experts in the world, as stating that 534 was a "super" Gleevec and he believed that it may even prevent some of the CML mutations from occuring, or at least stalling them off for a longer period of time. Does this all mean that, assuming 534 meets it's primary endpoints in the current pivotal trial, that we might be looking, in the future, at a first line treatment for CML? Looking forward to responses from our scientist members.
As usual, JMHO
Coincidence?
Did anyone else realize that selling 18.4 shares @ $3.70, will net the company(after underwriting fees) the same 65 Million that they were expecting to receive from a new drug application for Rida.
Is it just a coincidence? Hmmmmmmm
As usual, it's JMHO
Barry
From 89,000,000 to 130,000,000 Hmmm
Lets see. By my calculation that represents a 50% increase in shares outstanding since 2007.
Now lets see if the company's value increased or decreased by 50% since 2007.
In 2007 we were still in Phase 11 with Rida, and footing 50% of all the costs of developing Rida as compared to Zero today. Addiotionally, today we have finished P{hase 111 and await the results. What is that difference worth to the company?
In 2007 we were in pre clinical studies with 534. Today we are in a pivotal trial with 534 with fairly startling results
having been reported in a Phase 1, and with knowledge of the shifting of the first, second and third line drug options.
In 2007, and if 534 panned out, we were hoping for a nice partnership and probably getting double digit (lets call it 20%) royalties. Today we are looking at probably getting 100% of the major revenue 534 could produce (of course less the costs of manufacturing and selling the drug) What is that difference worth to the company?
In 2007, 113 did not exist. Today it is poised to enter the clinic next year, with exceptionally good pre clinical data.
None of the above could have been accomploshed without the funds raised by increasing the shares by the 50%.
You tell me whether or not the value of Ariad has increased by 50%, or more, or not. I, for one, believe that the value of the companmy now, vs 2007, has increased exponentailly.
As usual, JMHO, Barry
My take on the dilution
Though I feel the short term oain as well as the rest of you, and perhaps more due to my and my clients fairly large position, I am looking ahead and see the following
I recall all the same rhetoric on this board when Aria last diluted our positions. Though I don't recall the exact price of the last offering, I do believe that we are about 30-40% higher today than before the last dilution.
I, for one, love the idea that Aria may not partner the major revenue stream from 534 and I can see this drug (of course if all goes well in the pivotal trial) earning a net of $3 to $4 a share. If this dilution is the price we must pay to posibly allow this to happen, I am all for it . Lets not be so short sighted.
As usual, this is JMHO
I guess we will have some more information fairly soon to make a determination as to whether or not it will succeed. Lets see who is right Hedge.
Barry
One correction
SUCCEED trial "WILL NOT FAIL".
1- Drug is too safe
2- No new Sarcoma druig has been approved for over 20 years
3- Phase 1 and Phase 11 results tell us that the drug works well enough to be approved.
4- The FDA knows that there are thousands of patients who are in need of a drug to help with their sarcoma.
5- Merck has the experience to navigate the drug to an approval.
Barry
Interesting New Find Re: an Ariad Drug
Bellicum Pharmaceuticals is a Bio that is using Ariad's first drug candidate (AP1903) in combination with their own drug, to develope a Prostate Cancer Vaccine. Now I discover that they are also developing another drug which uses AP1903.
Only the veteran Ariad investors (like myself since 1994) will remember what I am about to say about AP1903, but here goes.
Somewhere about the year 2000 or 2001, Ariad developed a drug called AP1903, which was in effect a switch, if you will, to turn genes on and off in the body. Harvey, at the time, explained that when patients need to replace their immune systems, same is accomplished by doing a bone marrow transplant. The problem, however, was that quite often after a bone marrow transplant the T cells attack the patients healthy tissue and doctors were unable to stop this progression and the patients eventually died. AP1903 was designed to regulate the genes after a bone marrow transplant and prevent this process which is called "Graft vs Host Disease", or GVHD. Ariad put AP1903 through a Phase 1 clinical trial with exceptionally good results regarding toxcicity (efficacy was not tested in this Phase). Upon completion of Phase 1, Harvey (at the next few ensuing brokerage conferences) kept saying that a Phase 11 was in the planning stage. Phase 11 never happened, and eventually Harvey admitted that none will be done in the near future because, although the drug works well and is not toxic, the scientic community was not advanced enough to be able to utilize this drug. LO and behold, this is exactly what Bellicum is now doing with a drug they call "CaspaCIDE", which uses AP1903 as its "switch" to regulate genes in patients going through Hematopoietic Stem Cell Transplantations (HSCT)
This, once again, confirms my strong belief and confidence in Ariad's science and scientists. If you are interested, you can check out what I just said at Bellicum's website.
As usual, JMHO
Barry
Phase 111 Ridaforolimus/Endo trial???
What are the chances of Merck initiating a Phase 111 Endo trial before Ridaforolimus is an approved drug? And if they do, does anyone remember how much the milestone is for a new Phase 111 trial?
Barry
We should soon learn of the results of Bellicum's Phase 1/11 clinical trial on their Prostate Cancer Vaccine, which is a combination of their drug BP-GMAX-CD1 and Ariads AP1903 Dimerizer. September 2010 was listed as the Primary Completion Date. The reason it is listed as a Phase 1/11 is that Bellicum's drug is in Phase 1 while Ariad's drug is in Phase 11, having completed a Phase 1 in 2001.
Ariad's tentacles are spreading out.
If anyone on the board has heard of any results on this trial, please let the board know. Bellicum is not a public company, so results are not required to be reported out.
Barry
Contrary to being detrimental, the longer time frame is some proof that the drug is working just fine. Keep in mind that the the time between the three analysis periods is measured in number of ADVERSE EVENTS. Therefore, the longer the time period, the lesser the ADVERSE EVENTS, albeit, the drug must be working. As an example if the time period between the first and second analysis was only two weeks......that would mean that 1/3 of the adverse events occured in just two weeks and would clearly indicate that the drug was not working well.
JMHO
Barry
For two reasons:
1- We own 100% of 534 and only have a % of sales of Rida.
2- 534 is at the stage that the all important pivotal trial is starting and much info on the design, prospects of success and market must be divulged to the shareholders, while Rida is at the stage that, with one exception, nothing new will happen for about three months (till the final results will be reported on). In addition, it may very well be possible that Merck will take the lead in reporting Rida progress (which might be part of the new agreement between Merck and Ariad). The one exception alluded to, is that by the end of this month, at a International Scientific Meeting, results of the Rida Endometrial Phase 11 trial will be reported on.
JMHO, Barry
First let me tell you that I am an accountant and tax attorney. Please understand that Aria has a huge carryforward tax loss and they will not be paying taxes for some time. Secondly, I used the the term profits or earnings because there is no cost to the milestone payments and in accounting venacular we say that it falls right to the bottom line. Yes the milestone payments will be booked on the top line (just like sales) and with no costs to earn said income, it will fall to the bottom line.
Next time please be somewhat conversant and familiar with what you expound upon
Barry
BOLD PREDICTION
2009 was the last year that ARIA will operate in the RED.
Beginning with 2010, ARIA will report profitable results for many years into the future, and here is why.
1- Based upon the financial results reported today, ARIA has a lock on ending 2010 in the BLACK.
2- Based upon their statement today that they will be reporting milestone payments as current income (and not amortized)
Aria, even if they do not have any Rida drug sales in 2011, will most likely be profitable from the milestone payments alone. If, as I expect, Rida is approved prior 12/31/11, then the sales of Rida in 2011, will only add to the company's profitability. We may also pick up some more EPS if 534 is partnered in 2010 or 2011. ARIA may also get some additional EPS in 2011 from sales of 534 on a compassionate basis, especially with patients who suffer from the T315 mutation.
3- Looking ahead to 2012, sales of Rida and additional milestone payments will again make this a profitable company and we might even see some sales from 534, either as an approved drug or compassionate sales.
4- Looking further ahead, and by 2013, there is no doubt in my mind that with two solid oncology drugs, ARIAD'S EPS will be solid and growing exponentially.
So, Bye, and good riddens , to all the RED INK, and HELLO and WELCOME to PROFITABILITY>
JMHO, Barry
That's what I also heard in the Jeff conference. Pretty impressive and anxious to see when Merck will go forw