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You still hold your Ariad position? 4 for 4 would be one hell of an average and just fine with me.
Last check Amgn had 40 something bil in cash. Plenty of room for another mid level bolt on. ;0)
Perhaps something to do with this:
http://www.crainsdetroit.com/article/20130607/NEWS/130609886/ash-stevens-receives-12th-fda-approval-for-innovator-drug#
He can say whatever he wants (and he sure had a lot to say yesterday), but for Ariad to "win", Iclusig clearly has to do well into the 50's. There must be a definitive difference between Iclusig and Tasigna/Sprycel for that switch market (2 bil+) as well.
Berger/Ariad have a history of not meeting timelines and setting up Ariad stock for failure. He did it again yesterday with his comments about EGFR T790 data at ESMO. Those of us who follow the company have seen them miss self established deadlines before and pay the price.
The street essentially just gave 113 no value in T790 and has declared CLVS the winner by virtue of its 2 bil+ MC. Why not STFU and catch everyone sleeping at ESMO instead of setting up for another data deadline miss(or perhaps worse a disappointing data set).
This company is looking very good at this point. If Iclusig 12 month MMR is somewhere over 55%, he won't have to say a word. Let your product do the talking. I'm starting to sound like friggin Dew now. Sheesh!
BTW, this is all just a rehashed Don Shimoda rant.
Nice post from "The Don". I find this little nugget of particular interest:
"According to Ariad, 50% of crizotinib resistant patients progress with brain mets so this could end up being a key point of differentiation between the two drugs. It also may afford AP26113 a possible path to a first-line setting"
Could you expound a bit on that idea?
Excellent! Thank you for the effort.
Good stuff JQ. I'm invested in Ariad for a long time. I've sold some but I'm still here mainly for the potential of Ponatinb. I believe it has good chance to become a monster. Lots of shots on goal.
As you say it will take time, but I would like to find out if Cortes is planning on presenting the 12 month MMR at ASH in Dec. If so, I think Ponatinib becomes the most prized, un-encumbered oncology asset left out there. As I see it, if Ariad goes alone that's great. The launch has started off really well and should get better as the word get's out. If the 12 month MD Andersen MMR is say 56-60%, it will really generate some buzz.
However, there are some significant BP's out there right now without a PD 1 or a Ibrutinib to go forward. If only Berger would shut his mouth and stop setting the stock up to get creamed, we might have something interesting. Stand alone or bolt on, I don't really care.
Thanks for the input and GL
Great discussion.
IMO, in time, 113 has a good chance of showing it's head in ALK+ and ROS1. I don't know if anyone could form an educated opinion of EGFR at this time. I do think the tolerability factor and (hopefully, what I believe) a slightly better response and duration will separate it from LDK378. LDK's numbers were not a great as I thought they would be. As Don pointed out, the fact that many can't stay on the drug is a key factor as well.
I really don't know what to make of the Chugai drug at this time, it is a bit of a wild card in my mind. I guess we will have to see what becomes of it.
In my model for 113, I have peak sales of approx $500 mil basically all ALK+ and ROS1. EGFR TBD, but $0 for now.
Your analysis reminds me of kinda how you viewed Ponatinib when it was given the black box label. I know you now have a long position. I was wondering what made you a buyer. Was it more favorable valuation, better clarity on the Pona safety profile or a combo of both? Also, did the 3 year follow up ease your mind on safety? What 12 month MMR do you expect from EPIC? I expect the safety profile to be in line with the rest of the TKI'S.
TIA
JQ
There have been numerous patient reports (as well as Getinger's claim on the Asco CC) that 113 is clearly better tolerated than LDK. I believe that will be a clear differentiator in the end.
IMO little to no value has been assigned to 113 in Ariad's pps at this point.
Main point there being Criz naive and Chugai still has to run trials in the US.
Against LDK, it seems 113 has a clear tolerability advantage as well as just as good if not better efficacy (with what seems like very good brain mets activity).
I'd agree it is still too early to declare the winner but it seems to me that the market has clearly declared 113 the loser (In EGFR with CLVS as well).
Thanks, I figured as much. Don pointed out that MD Andersen trial was started in April of 2012. We should get a 12 month MMR readout, as well as a good look at the safety profile from that trial at ASH in December. There should be a very clear picture for Ponatinib in 6 months.
Peter/JQ
With this 36 month data, is it at all possible for Ariad to request that the black box label be modified?
Also, any chance the that the EMA label is expanded to the 2nd line being the 36 month data was unavailable when the CHMP opinion was given.
TIA
I held Amrn for a long time before cutting my losses a few months ago. Can you explain to me how the NCE decision could be so delayed? For the life of me I can't.
Fwiw I see value here as well.
TNFerade In pancreatic. My first real Biotech Blowup.
$3 to .50 after hours. It's been all downhill since then.
Nice to finally have you on board.
(Signed the poster formerly known as Aria2010)
Put up the other hot chick with the hair in front of her eye
One was known already. Kind of snuck in at last ESMO cc
We have a second sudden death
Hey I think you guys need a nice NVS standstill agreement post right about now
I hear ya, but 3 bil mc is going to be dirt cheap if it blows the doors off in EPIC. Plus, at this price, you get the 113 chaser on the house.
No love for Ariad here on BV? Pretty nice start for Ponatinib, especially in light of the fact that it is a dirty drug, with a bad AE profile and a high discontinuation rate.
Agreed (eom)
Fwiw, Jeffries recent report says Q1 could be as high as 9 mil.
Agreed not something I was hoping to see.
Well I did just that. Did you?
That's a disgrace. Favus should be very proud of himself.
A good objective discussion is always welcomed and key to biotech investing success. A fictitious hit piece (imo) intended to drive the stock price down in order for some to cover and profit is another.
As you say, time will tell who is right about Ponatinib.
Berger has been adamant in his belief that the AE's have been due to the fact that most of the patients have been previously treated with 2 other TKI's. Hopefully there is no dosing issue. If there is, Ariad is objective and ahead of it.
I would imagine Ariad's commentary will be more of the same. The MD Andersen and EPIC trials should help clarify things.
When can that be expected?
FAERS data is significantly different than that reported in the Favus survey.
Any comment?
Yes and I concluded a year ago that Ariad had the best in class TKI, with a beautiful, clean expanded label and would be trading over $30 by now. How did that work out for me?
Do the dd, cross your fingers and hope for the best. That's about all I know for sure these days.
It's a long way before you can claim best on class
Epic trial has become more of a binary event
That is one place that you and I are in full agreement. I/we have been blindsided by Berger a few times now. Black box, CHMP limited label, financings when we were promised no financings, etc all have me thinking about the Epic trial ramifications. Don has opined that Berger has a blind spot when it comes to these things. He is the founder and he might not be as objective about his baby as the next guy.
I prob will not be willing to hold such a big position through epic results this time. Reward will be huge for those with the cajones to hold, but catastrophe is def a possibly as well. The pps will get slaughtered.
Somewhere along the line I will prob lighten up again.
That's nice but this is the girl I brought to the dance. It doesn't make a difference if some other guys girl is Better looking, I still have to dance with my girl.
Point being this is Berger's style like it or not. He's made a lot of money for long-term aria shareholders so they/we can't complain.
I'm also not so sure I press release would've been as effective. This baby was getting roughed up pretty bad
I wasn't a fan of his final statement either. It struck me as a little too loose lipped. Don pointed out that legal was prob not too thrilled about that one. As far as the rest of the conference call is concerned, I think it was fine. Burger was defending his first born and the share price for his shareholders and the analysts that have high egg on their face and price tags on the stock.
As far as those who feel that he should let the numbers speak for themselves, it's a long way to the May conference call. I believe he felt he had to step up and try to stop the bleeding. The stock was in a tailspin and who knows where it would've landed or still might
Someone is not being truthful. I hope for my sake its not Ariad. See you tomorrow.
How can you consider this a valid unbiased opinion?
Peter could be right but this report is not something I consider relevant.
Boring or not, if it was a competitor that sponsored this report, how could it be considered unbiased?
I have no idea who sponsored it, but I will wait for a clearer picture before I decide if Pona has safety issues. Not AF's buddy and this obviously tainted opinion.
The reports I mention are usually those of the KOL's. Talpaz, Shaw, Cortez, Drucker those are reports that form my opinion of Ariad.
This Favus report is competitor sponsored. How on God's good earth can it be considered unbiased?
Perhaps Berger can shed some light on the AE issues that have become everyones favorite talking point tomorrow am. The stock could use some help.