Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Being a stock analyst in general is like being paid to promote Voodoo. They dont know any more than we do and that is just a fact.
I think the volume the last 2 sessions is almost all short covering. The final shoe to drop was the EMA opinion. Once that was resolved they lost interest. The expectations of Iclusig revenue in the future is so low as to be nearly non-existent so there just isnt anything left to short here. There will be in the future as 113 comes alive etc...but not this year.
Regards
G$
So how can Ariad and FDA come to such different conclusions as to what represents AEs?
That is part of the case here, is it not?
Seems the CHMP opinion sees it through Ariad's eyes per the release today.
Government negotiators will certainly exploit the FDA’s stance to get a better deal
Dew,
I dont want to accuse you of any conspiracy thought processes but....
FDA simply has more data at its disposal than any individual doctor, no matter how renowned.
I dont know if this is true, but I would think that the previously mentioned docs, combined have a large percentage of CML patients that exist in the U.S. whether in trials or in practice. If true, it would be odd to think, given their huge success in the safe use of Iclusig, that they are just not seeing or "missing" SAE's by virtue of having a cleaner initial patient profile. "Renowned" truly matters...as my comment suggests. Seems the data actually suggests this as well. Top docs already know how to administer Iclusig. Lesser talented docs obviously do not, or they have so few patients in an equally weighted statistical measure that the data is skewed from the beginning.
Dew, if you are saying that the FDA can match wits at the highest levels with Dr. Cortes or Dr. Druker in this arena then I would have to believe that you are off some meds or you had a mild stroke. Hoping it is the first choice.
I think the problem was once the drug was approved it became apparent over time the 2nd line indication might have been a mistake.
I disagree wholeheartedly. The best CML Dr's in the world...on the globe....in the galaxy, have obviously learned how to administer the drug safely...at ANY and ALL doses. There can be no more conversation that could rise above that fact.
Really.
absolutely illegal for a drug company to promote off label use!
First of all, take it easy....
Although I didnt know that, I stand corrected, I assume the sales staff knows not to do that but docs use their own heads to use off-label. A positive word about 2nd line patients from a salesman would be hard to prove as promotion imo.
Also, from where is this certainty that ARIAD was not cooperating wit the FDA?
I dont know, you said it. I was referring specifically to the potential of Ariad sales team promoting off=label
All of its clinical protocols would have to be FDA approved before hand
Does that include what constitutes an AE or SAE prior to the onset of the trials? I know you dont know so dont bother with this one.
I truly believe ariads unwillingness to play ball is what caused the fda to take its hardline position
lax, your statement is an epiphany in my opinion. You have solved the riddle. I really believe that is it. However, it isn't against any FDA regs to promote off-label (and this is hardly off-label from an ethical standpoint) use. Am I incorrect in thinking that?
Problem is, thesaud, facts dont appear to matter. There is a rift between Ariad and the FDA. Cannot be denied. If you needed confirmation, the personal nature of Dr. Pazdur's comments in a recent article speaks volumes. Lots of inappropriate, unethical behavior at the FDA as far as I am concerned.
ARIA lays off 40% of staff (160 jobs)
Great move. Expected move. Get lean and move forward. CC can now avoid 10 minutes on the Q&A ref layoffs.
Next move....Partner AP26113 at highly favorable terms (If I were CEO)
This appears to be what happens when you start patients at 45mg and just send them home without paying attention. Looks like it comes down to physician credibility. I will take Cortes and Druker.
Funding; Novartis
that article would be worth $2 in pps if it was attached to any other biotech. Awesome data. I like the pre-emptive feel of the trial reference dosing
Ultimately I will settle for a solid business plan coming out of that CC. The news would probably come days after the CC unless HB says directly that he will not partner.
Either way, HB needs to step down for any comeback of the pps. The shred of cred that he had evaporated.
I am sure most everyone is waiting for "the plan" to come out in the earnings call before too much will go on with the pps. There are so many different ways to attack this. I just hope HB makes a move to improve shareholder value vice being too stubborn to make a needed move...i.e. partnering 113
Partner 113....250-300m upfront. Financial woes solved for quite a while.
The very bottom line here is that Docs know how to manage Iclusig already. It is being proven in the lack of world leading Oncologists' negative feedback throughout the life of the drug. Cant argue with it and I have to continue the drum beating here.
the huge disparity in the SAE/AE data from the various sources is curious and suspect. Only 2 things could be happening here as far as I am concerned:
1. Criteria and definitions in general are different between FDA/ARIA/NEJM....which is a huge failure of the system or
2. Somebody is flat out lying.
Gotta continue to be a buyer here. Per usual
If the FDA is right about the 48% SAE's, then the SAE's must have a very skewed distribution, and Dr. Druckers CML patients must be very lucky to miss out on all those terrible side effects...hmmm interesting...eh!
___________________________________________________________________
That statement sums up the 600 pound gorilla that has been in the room since day one of the debacle. We just havent seen the best CML docs in the world talking SAE's
Also the timing of that preferred issue
I don't have the slightest idea what this means. What is the motivation and who is it for?
just looking for clarification
The evaluation of the data will now take some time
That would be nothing more than an excuse. Evaluation has been going on for years and continues. This entire debacle was caused by a personal riff between HB and the FDA which is nearly unfathomable to me. Personal vendetta's are not what being professional and objective is about. I want to sue the bastards at the FDA so bad I can taste it
Read the FDA release...patients who are benefiting from Iclusig would continue to receive treatment under an IND
And absolutely the strangest thing about this is that neither Harvey or TC knew that....they spoke directly to it during the cc yesterday.
2da, it was on the last part of the call where that exact question was asked.....
nobody is getting the drug. You would think that this is where prescribing docs like Dr. Cortes make direct contact with the FDA.
wake up this wasn't a choice. They were notified by the FDA yesterday afternoon. THis was the earliest they could announce it and to wait wasn't possible.
On a scale of 1-10...10 being the highest level:
How irresponsible is the FDA in taking the drug from the sickest patients with no alternatives?
With Sarissa Capital involved, I believe a sale of the company is now a forgone conclusion but that doesnt mean it will happen within 2 years.
quote:
If they get a board seat(s)
The two edged sword. The best thing that HB could be doing this morning over coffee is working to ensure Denner gets a seat or 2 imo. Of course if that happens then he sells his soul....
vid,
for clarity, I did sell prior to the crap storm but I also repurchased a percentage of my original holdings prior to said storm. I have also purchased quite a bundle between $2.90 and $5. I have also made a ridiculous living overall in ARIA.
My investment in Ariad has always been based on data, common sense and the thought that there is something to the rumored R&D prowess. I mean, you dont just guess and come out with deep response drugs that, for example, seem to tackle brain mets.
Iclusig on the other hand has now become a sleeper in more than one indication and could very well make up the loss of volume revenue with premium pricing. This could be significant.
Seems to me that coming soon (1 week-5 months) will be:
a) sublease of previously leased real estate or buyout lease and take a whipping.
b) partner a drug. I would partner Iclusig (300m upfront) to fund 113 and beyond.
c) cut staff but not to the bone and not from R&D
d) FDA decision on Iclusig intervention dosing
e) AP26113 dominates as expected
I believe the only potential negative which is highly unlikey is total revocation of Iclusig.
Ariad will surprise between now and 3 years. I am a buyer as usual
Ponatinib trials, all statuses
Recruiting second line CML. Nugget?
at this point, Dr. Cortes' data in a front line setting is not very valuable
In reality, this is some of the MOST important data going forward ....DR. C dropped the dosing to 30mg (once again, not because of AE's). He understands the drug fully and could very well, on his own be creating the optimal dosing.
Does anyone think Aria is going bankrupt. I know the selling recently seemed to say we were putting out the closed sign, but I still believe in part or whole there is more value than the current share price. Opinions please.
1. No chance of bankruptcy....absolute zero
2. Lawsuits wont even get class status....lots of guessing...no facts
3. Iclusig continues 2nd line thru salvage = blockbuster drug in time.
4. Hopefully, there is a hybrid purchase of ARIA like the one that Harvey and others have mentioned with a premium coming in a few years based on milestone completion.
Go to sleep for a year and stop listening to the incessant whining of those that use to call themselves longs.....
This is a difficult holding but will prove to have a platinum lining. It already has been for me and God's gift of the re-load period right now will lead to the purchase of 500 acres of branch bulls for my amusement
quote
products have gotten better as they come to fruition?
I was waiting for someone to go there....you win my psychology prize. Congratulations
So, lets talk ODAC panel. Here's a question for you larger brains:
1. Does the panel have to be comprised of a minimum percentage of Oncologists...I assume there is a selection criteria?
quote:
CELG overcame Thalidomide
That is some serious precedence imo.
So you have analysts.Kasimov, good old Rachel, all of them...and they have taken a credibility hit and they are personally hit by that. Of course they are paid to give guidance to the masses, so I get it, but their feelings are hurt. But I would almost guarantee that in their own minds (most anyway) and maybe as spoken to friends/family, they know now is the real time to accumulate...."Hey Mama Kasimov, pick up some ARIA while you are out".
Random thought:
Ya know, their is a chance...no matter how small..that the FDA has a few positive comments on Iclusig that could bring this to $10 as quickly as it went to $5.
Quote:
you would run a small trial
Just how long would a small trial like that have to be? Enrollment numbers necessary?
does it seem odd that there arent docs out there right now doing that? or has the question just not been asked?
why the huge drop ?
Because Ariad made another huge tactical error by not making the EPIC stoppage part of the announcement in the first trial hold PR. This is just another reason that HB needs to step down shortly....There is a great science team at Ariad but they couldnt manage their way out of a wet paper bag. They just arent astute business minds.
Another interesting (and obvious) point made was that the reason long term
patients on Iclusig experience have SAE's, is that they're still alive, whereas
with the other TKI's they would be already dead.
We have approved cancer drugs that extend life by a few months. Iclusig
in contast extends it by years, and for the vast majority, without SAE's.
__________________________________________________________________
See, the problem with you Ample is that you tend to make too much sense. The above statements are exactly what people, to include the dingbats at the FDA, should be basing their decisions on....but NOOOOOOO, instead there is bunch of whining going on. Stopping the EPIC trial was a no brainer....cost too much money since we ALREADY KNEW last week that 45mg would only go forward in the absolute worst cases. Anyway, buying as I can as usual.
>docs may be less concerned<
This nugget has been in the back of my mind since the AF hatchet job.....we just didnt hear negativity from prescribing docs....and still arent from what I can tell.
>head fake<
I was thinking the same thing.
New concern for the day is the sell-side dicks making statements like the trials may not be opened at all. So, they are protecting themselves just in case or there is more data out there than we know.
From Ariad Change in Iclusig development PR:
The Company is implementing the following actions in its Iclusig clinical development program:
http://investor.ariad.com/phoenix.zhtml?c=118422&p=irol-newsArticle&ID=1862864&highlight=
excerpt: .....subject to agreement with the FDA, will be resumed with anticipated changes in dose and other modifications
I find there are some telling words in the PR. Worth an additional read imo.
I read monarchs posted material. thanks
What is a realistic timeline for an FDA decision on reopening the trials? I am going to assume that Ariad already had a documented contingency plan that should be in the hands of the FDA at any time, if it isnt already. Or am I too optimistic?