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No BUT
I am expecting news to be released just prior to the August 2, conference, via an announcement prior to the market opening
JMHO, Barry
Mrk and the NDA
Severasl days ago I called Merck and asked for the email address of a Board Member so that I can lodge a complaint about a drug (MK-8669 (Rida) )
I was told that they do not give out any email addresses but that I can lodge the complaint with a person who they put me in touch with.
I told them that I wanted to know why an NDA has not been filed yet for MK-8669, despite having met its Phase 111 endpoingt more than 6 months ago. I also complained about the drug's competitor (Afinator) marching along in the clinic in one indication after another, while Merck sits on a drug that could help thousands of cancer patients. The gentlement took notes and even assigned my complaint a number and said that someone will respond.
I will kep the board informed, and perhaps others can make complaints.
Barry
Are we headed towards a new ten (10) year high?
Today we matched the highest the pps has been since May of 2004 ($12.48)
The highest the stock ever traded in the past ten (10) years is $13.74 in April of 2004.
The way we have been trading, it certainly looks like a new ten (10) year high is in sight, and if we do, $15 a share is a very logical follow through.
JMHO, Barry
113 in the clinic next month
As we filed the IND by 6/30/11 and the FDA having 30 days to either approve or place it on clinical hold, it appears that 113 should be approved for Phase 1 sometime late this month, with a launch sometime of next month.
Barry
I believe Haluska suggested that we will have full enrollment by early third quarter, and I am therefore expecting full enrollment by about July 31.
Barry
Welcome back
It's been a long time, but welcome back Mito. I am looking forward to your insightful comments. Please let me know your take on the forseeable future of Aria, say 2 to 3 years out.
Warm regards, and I am sure you, like me, miss the Duke.
Barry
Without revealing names
It sounds incredible to me that despite:
a) Ariad rising about 110% since Jan 1, 2011
b) Ariad selling at it's highest PPS since May 28th 2004, when it closed at $10.74.
c) The PPS rising almost on a daily basis, despite a bad market, trouble across the pond, fear of a double dip, etc.
d) Phase 111 completeed and primary endpoint achieved with it's very first cancer drug. Especially considering that the odds of getting a drug approved is probably 20 to 1, as I read that only about 1 in 20 developed compounds finally get approved as a drug.
e) Efficacy so good with their second cancer drug that the FDA allowed us, in effect, to skip a full clinical Phase step and go into a pivitol trial.
f) Predictions by the CEO that Ariad may have two drugs approved for sale by 2012 year end.
g) Recent revelations that the very first drug developed by Ariad, (about 10 years ago), and which Ariad took successfully through Phase 1 and came out with flying colors, and which Harvey finally said two years later that the company will not conduct a Phase 11 because of the limited funds available and the more important fact that the then present state of Medical Science was not advanced enough to utilize what AP1903 can do. Well Medical Science has finally advanced enough so that AP1903 can now finally do it's thing and it sure appears that Bellicum saw that potential and is proving it now. This is why, and I believe the only reason, that Harvey started referring to AP1903 as our 4th compound. Though it was actually the first developed by Ariad, we have already been calling Rida our first drug and Pona our second, so why change all the number references instead of just giving 1903 the next number pulled from the number machine at the Ariad Bakery and Sweet Shoppe :O).
h) Recently learning our third drug will be entering the clinic in short order and further learning that even before entering the clinic, it's possible market has tripled. And also learning that it's future competitor (Crizotinib), was one of the biggest stars at ASCO, and I read where one analyst said that Crizotinib may be able to garner 4 Billion in peak sales. Also learning that our labs believe that 113 is 10x more potent than Crizotinib and up to 100x more selective and can treat all the Crizotinib mutations.
i) Not to mention the many other indications that # 1 and 2 may eventually address.
Despite the above, we still have posters trying to throw a damp towel on our warranted enthusiasm, by CREATING a 4th compound failure scenario, as a reason for calling 1903 our 4th compound and implying that Harvey is pumping the stock to conceal same.
I have been an investor and trader of Ariad since 1995, and in my opinion, the prospects on the company have never been brighter, and the science never better than at present. Sit back, as I am doing, and enjoy the ride.
As usual, just MHO,
Barry
The attorney thanks, :O)
Barry
Welcome Mican
An unexpected court appearance will prevent me from attending the meeting tomorrow. Please let us know what you discern from the reading of their body language.
Thanks, Barry
I'm Guilty
A few months ago, before the April conference when Harvey alluded to more compounds, I posted a list of predictions as to what we could be looking forward to for the remainder of the year. One of those predictions was the announcement of a fourth compound.
Harvey's statement in April confirmed (at least to me) that this prediction of mine will probably bear fruit this year. When I published my post, I did not, for a minute, mean to imply that a fourth compound would have any initial effect on the PPS. I see, however, that some posters on this board are almost upset with the idea of the introduction of another compound, reasoning that Ariad must concentrate on our present robust pipeline. To those posters I advance the following:
1- Ariad obviously has a very effecient and productive R&D team. Do you really think that the company will stiffel their inventiveness because we have several very promising candidates to becoming meaningful cancer drugs?
2- I am sure that this R&D team spends almost no time on helping Ariad march Rida, Pona and 113 through the clinical process. I am sure they are busy at work and very proud of their contributions to the company. Their work certainly does not interfere with, or take away any concentration from the process of having Rida, Pona & 113 gain access to the marketplace.
3- The pipeline of a Bio is the compounds that they deveolop and or acquire and I am sure that their good science will continue.
4- Eventually I see Ariad as a drug discoverer, a company with expertise in bringing their drugs through the clinical process and brought to market, a drug manufacturer and a Pharmacy company that specializes in selling oncology products. This is what I believe Harvey has in mind and in store for Ariad.
I will predict it once again. Ariad will announce a fourth compound in 2011.
As usual this is JMHO,
Barry
BTH
The warrants that were exercisable at (I believe) $8.64 plus one warrant to get one common share?
Had quite a few of them myself :o)
With all that was said at the Analyst conference, what's left to say on Thursday?
Barry
Though I strongly believe that Ariad has developed, and will announce a new drug candidate this year, given the panel that will be present, Friday is not the forum to make such an announcement. A more appropriate forum might be at the next annual meeting later this month.
Thanks Glass
Thanks
What is the "HR" measurement the trial results refers to?
Thanks
Anyone have the link to the news?
What you say makes sense, but I still believe that there are other motives behind the decision to hold the conference. One things for sure, we will know in less than a week.
Thanks, BTH
I don't recall Ariad having a conference call immediately after any other (prior) medical conference presentation. It is unusual and I can only conclude that it's purpose is either of the two I just mentioned
June 6th at 6:45PM (Conference)
Can anyone hazard a guess as to why Ariad scheduled a conference immediately after their final ASCO presentation?
I can certainly think of scenarios that run from "putting out the fire" to "bragging about the results just presented"
2011 Predictions (or at worse, my wish list)
1- Merck files a Ridaforolimus NDA by no later than July 30th 2011
2- FDA approves Ridaforloimus by 4th quarter 2011 or first quarter 2012
3- Ariad partners Ponatinib in Asia before years end
4- Ariad announces a new compound before years end
5- Ponatinib clinical trial is fully enrolled by August 15th 2011
6- Before years end, Ariad reveals preliminary data on Pona clinical trial
7- Ariad initiates a Phase 1 clinical trial for 113 by July 15th 2011
8- Ariad shares trade at $20.00 a share (some time before Christmas)
9- Ten (10) of the Ariad message board member, meet in Manhattan for a lobster dinner and party, prior to New Year's Eve
As usual this is JMHO,
Barry
New Compound
Several days prior to HB telling us that the PONA trial was ahead of schedule and that complete enrollment would occur in the third quarter, I predicted on the board that full enrollment would be achieved before 9/30/11
Now I am making another prediction. Aria will announce a new compound this year.
As usual, JMHO Barry
Thanks
Barry
The Abstracts
Can anyone please give me the link to read the Abstracts tonight?
Barry
Absolutely
Wouldn't you upgrade a stock when you learn that they will start earning money 6 months earlier than you estimated in your last issued target?
And you learn that they expect to have two (2) drugs on the market next year/
Barry
Loved The Press Release
I, for one, absolutely loved the Press Release and actually predicted it at 9am this morning (see post #7507). I loved it for several reasons:
Much earlier conclusion of the Pona Trial, which also means we will be getting revenue 6 months, or so, earlier (gotta love that)
The company's confidence that they will be selling two (2) drugs next year.
Real close to a Phase 1 113 trial
If you subtract the ONE TIME charge for the reevaluation of the granted options, they were right on target
We still have 100 Million in the till (which I believe is a bit better than previously guidance)
A strong indication that the succeed trial will show very strong OS figures.
That is what I call a wonderful press release
As usual, JMHO
Barry
Just what I observed, which led me to believe that there will be a surprise announcement. We know that they will announce a loss for the quarter, as there was no revenue to report, so I can't imagine that they pushed the PR up to the night before just to let the investors ponder the loss overnight.
as usual, JMHO
Barry
Tonight's Press Release
The CC PR stated that the company will be issuing a PR after the market closes on 5/4/11 (tonight)
Any guesses as to whether or not we get a surprise announcement?
My best guesses are either, or both of the following:
Announcement that the Ponatinib trial will be fully enrolled by no later than 9/30/11
A partnership with a Japanese Pharma
As usual, JMHO
Barry
not sure , they have not announced the Annual Meeting date yet.
Hey Bill
I will be there for the next annual meeting and will llok forward to meeting you and whoever else from the board shows
The original guidance for full enrollment of the Pace trial was by "year end 2011"
Barry
My Prediction
With the speed Ariad is signing up Sites for the Ponatinib Trial, and based upon listening carefully to the words HB used in the last few conferences, I am going out on a limb and predicting that we achieve full enrollment by no later than September 30th. If that happens, it will be a full threee months ahead of the original schedule.
Annual Meeting
Raise your hand if you are planning to attend the upcoming Annual Meeting.
I think it would be nice to see if we can get a group together to have a nice meal in Boston and a chance to meet some of the posters in person
Barry
Gracias, Poor
Pricing for Ridaforolimus and Ponatinib
While doing some DD on Ponatinib, I came across a site that actually sells Ponatinib and Ridaforolimus and gives the prices for 25 mg, 50 mg, 200 mg and 1 g quantities. They do state (on the bottom of the page in smaller type) that "sales are for research only"
Can one of the scientists on the board please explain how this company could be selling these drugs, prior to approval by the FDA?
The site is "Selleck Chemicals" and they are located at 2626 South Loop West, Suite 225, Houston, Tx 77054
BTH
I am 100% in agreement with that statement. As I said before, HB does tip his hand, and if you listen closely to his choice of words in one conference vs another, one can get a glimpse into some future events and strategies of the company. I also discerned (via the same method) that we can probably expect the announcement of the next molecule, sometime this year. Harv also sounded a bit more confident about Rida's approval for Sarcoma.
As usual, JMHO
Barry
Just remember that I said that a new drug candidate will be announced this year.
JMHO, Barry
Indeed not, but perhaps Ariad never devoloped the drug, is still working on one or abandoned the idea. What interested me was that Ariad worked on (many years ago) a drug to do what the British scientists now say is possible.
Have you given any thought as to what cancer, or disease, Ariad's next molecule will address? I do believe that before years end, we will learn about the next molecule. I do not, for a minute, think that the good scientists at Ariad are just sitting around watching their stock options grow in value.
Barry
Thanks Glass_half_full
I also found the article interesting, and in fact interesting for another Ariad related reason.
I have been investing in Ariad since 1994, when I had to read the original prospectus as part of the information I needed to represent a client in an Ariad related legal matter. More than the foregoing I can't divulge.
Now that the foregoing has been stated, needless to say I have followed the company very closely and remember many events involving Ariad and many statements made by management. I remember when their very first drug, AP1903 was first discussed and went through it's clinical Phase 1. I remember when Ariad was working on a method to inject drugs, such as Insulin, into an individuals muscle and it would remain there for an extended period of time, and when the individuals sugar level dictated a need for insulin, Ariad was developing a pill to give the patient that would cause a release of enough insulin to deal with the patients need. In fact, Ariad actually had a monkey (or several) in whose muscle the insulin was injected and Ariad, from time to time, would announce how long the insulin was still bunched and reamining in the muscle, in tact. Last I remember was that they were able to keep the insulin in the monley's muscle for several years. Of course, if this method was ever fully developed, they could have put it to use for many different drug needs to be released into the body by simply taking a pill not an injection. Morphine, comes to mind immediately etc.
Now back to the point I want to make about this very interesting article, and I hope some Ariad old-timers might also remember this and confirm what I am about to say. I can't remember the year, but I do recall it was at least 10 years ago, or more and it was about the time that Ariad changed it's direction to dedicate the company to developing only cancer drugs, and in effect, discontinuing the drugs and systems I discussed above. I vividly remember HB discussing the cancer drugs that Ariad was developing and talking about a drug that would treat cancer that had metastersized, and or prevent cancers from metastersizing. Could it be that Ariad knew 10, or more years ago, what the scientists in England are now reporting? Or could it be that Ariad is working on a drug to do what HB said way back then? Hmmmmmm
If You Were Mercks' CEO
If you were Mercks' CEO, what would you do with Rida over the next few months?
1- Would you "stand pat"? Not extend any of the clinical trials until you find out for certain that the FDA has approved Rida for Sarcoma?
2- Agressively seek to expand the usefullness of RIDA by initiating Phase 3 trials in Endo, Breast and or Prostate, believing that Rida will be cleared by the FDA to treat Sarcoma, and therefore reducing the time it will take to extend the indications for Rida.?
3- Stand pat and while you are awaiting the final results for the success trial, make a move to buy Aria?
If you were Mercks' CEO Hmmmmmmmm
Barry
Thanks BTH
Both mine and my clients wallets are pretty healthy this morning also, and I suspect this is just the beginning.