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Great analysis 2da...Ask and you shall receive!
At the same point yesterday we had less volume and by the end of the day volume was above average...Look for volume to build into the close...
I'll drink to that..."The Death of the Shorts"
Can anyone explain how 300,000 shares changes hands in the last 2 minutes and there is absolutely no change in the share price...
I also listened to Clackson...and have to agree...While I think HB's PR sense, dillution timing etc.. have been terrible..One must admit that he has maintianed what appears to be a very productive group of laboratory scientists apparently happy and focused for many years...To be absolutely fair this must be included in our evaluation of Berger and taken in light of everything we see happening and about to happen....Clackson has always been the genius behind the compounds...Seeing him on this interview only confirms for me his undeniable importance to the future of ARIAD ... May 2011 be a happy, healthy and prosperous year for ARIAD longs...
I can't recall if we talked about this..It clearly adds weight to the idea that RIDA chances are decent...
Afinitor gains indication for subependymal giant cell astrocytoma associated with tuberous sclerosis
November 01, 2010
Novartis announced that Afinitor (everolimus tablets), an oral kinase inhibitor, has received accelerated approval for subependymal giant cell astrocytoma (SEGA), a benign brain tumor associated with tuberous sclerosis (TS), in patients who require therapeutic intervention but are not candidates for curative surgical resection. This approval was based on data from an open-label, single-arm, 28-patient study that evaluated the efficacy of Afinitor. The study showed that 32% of patients treated with Afinitor experienced a reduction of =50% in the size of largest SEGA at six months relative to baseline. The duration of response for these patients ranged from 3 months to 2.5 years (median 266 days).
Afinitor is already indicated for the treatment of advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.
Can we have the origin and date of the note?
The daily movements...the late day volume...the sudden reversals..what does it all mean? Maybe the bigs are simply on a mission to frustrate the smalls to the point they give up and sell out. Very unclear what was happening with this stock today...
Reviewed the report of the second interim analysis of RIDA by the DMC. I noted that in the press release it says:
The DMC advises the sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial, as well as the continuing validity and scientific merit of the trial. According to the study protocol, the DMC is responsible for undertaking the two interim efficacy analyses.
Does this mean that the 3rd and final analyses is in Mercks hands and not the DMC's...
Seemed like it held steady during that last 150 k ..Not sure I can tell what's happening at these high volume moments at the end of the day..it's clearly a pattern...If you were a big player(s) buying in at these times is there any way to disquise what your doing??? maybe its the website I use but I normally do not see that large of a ask position at days end..makes me think that perhaps its accumulation with an effort to do so under the radar...
It clearly is significant..however I would't overstate it..I am still in the camp that says Rida Sarcoma is better than even odds..Historically Rida has performed reasonably well in each of its trials...It is a drug with significant proven efficacy's...I guess my decision not to sell half my holdings before the announcement (which is probably the smart middle course to take) tells you where I'm at..but I deffinately understand your concerns..
I don't think it's particularly significant...I would bet the farm that at minimum Merck sees Rida as a molecule that is going to be commercialised... if not in Sarcoma's ..then as a singular treatment and in combination with other compounds to treat other types of cancer...You were the one who published the biography information of the Merck Manager whose roll it is to guide the worldwide launch of Rida..Clearly they have plans for the drug...I do understand that your focus is what this might tell us about Sarcoma...however I am more troubled by Harvey's being surprised and disappointed that the second interim was not difinitive...after he went out on a limb and suggested that that data set might be enough to complete the NDA..That tells us that one of the most knowledgeable people on this drug anticipated it acting more powerfully than obviously it did..That worries me more than this name stuff..
Interesting Point - Didn't we have a few message board entries about some names that had been trademarked several months ago..I cannot remember the name but the discussion sticks out and I remember thinking it was unclear whether these names would be reserved for Ponatinib or for Rida...I remember there was at least one name that sounded good...I will try and go back and find them...
There are 650 patients in the Phase III Rida Trial
the final PFS was reached in Late October early November---
I don't see why it would take 2 solid months of work to separate the two arms and make a comparison of the median progression free survival for each 325 patient set...Let's put it this way if it does not get announced before the end of the year it is not because they could not complete the analysis by that time. I am expecting a late December announcement despite what Harvey is saying....
My favorite part of the abstract:---------------------------------------------------------------------------------------------------Of 32 evaluable CML CP pts, 30 (94%) had complete hematologic response (CHR), and 20 (63%) had major cytogenetic response (MCyR): 12 complete CyR (CCyR), 8 partial CyR (PCyR). Of 20 CML CP cytogenetic responders, 18 remain on treatment (mean duration 326 [range 142-599] days) without progression, 13 of whom had response confirmed with at least a second assessment (9 with MCyR =6 months), and 2 pts treated at 4 and 15 mg progressed after PCyR. Of 11 CML CP pts with T315I mutation, 11 (100%) had CHR, 9 (82%) had MCyR (8 CCyR). For 16 evaluable CML AP/BP or Ph+ ALL pts, 5 (31%) had major hematologic response (MHR), 3 (19%) had MCyR, 1 (6%) had minor CyR. Of 9 CML AP/BP or Ph+ ALL pts with T315I mutation, 3 (33%) had MHR, 2 (20%) had MCyR. Responses were also observed in heavily refractory pts with no mutations, and pts with other mutations, who are resistant to approved TKIs: 1 CCyR and 1 PCyR in 2 F317L pts who each failed imatinib, dasatinib, and nilotinib; a F359C pt who failed imatinib and nilotinib had CHR and CCyR. Overall, 13/60 (22%) Ph+ pts achieved major molecular response (MMR), including 12/42 (28%) CP pts, 6/15 (40%) with T315I mutation confirmed at baseline, 10/40 (25%) with starting doses =30 mg. 12 MMRs occurred in pts who were on treatment =4 months (4 MMRs =2 months). MMRs were also achieved in pts with M351T, F359C, F317L, M244V, G250E mutations, and 1 pt with no mutation. PD data demonstrate sustained inhibition of CrkL phosphorylation above 15 mg. Initial safety, PK/PD, and molecular response data suggest both dosage forms behave similarly. Importantly, at doses =30 mg, both result in trough concentrations >40 nM—the target concentration for inhibiting all BCR-ABL mutants, including T315I. Conclusion: The 45 mg dose (tablet form) was chosen as the recommended dose for further study. There is strong and continually increasing evidence of anti-leukemic activity in pts with T315I mutations, and pts resistant to second generation TKIs. Emerging MMR data demonstrate early responses in pts refractory to second line agents-
it may be that the term lock up is not properly used but BTH did get it right that key ARIAD Directors acquired stock in this offering...See the link below for at least one transaction...
http://www.sec.gov/Archives/edgar/data/884731/000114036110042420/xslF345X03/doc1.xml
A Well Reasoned Post from the Yahoo Board...Who would have thaught?
In July of 2009 right after HGSI had its first big news the stock jumped from $3-$4 to $14. They immediately did a enormous public stock offering at a lower price from the previous close. All of the press releases were negative and the stock dropped back into the $13's. Less than one month later, the company announced more results and the stock jumped to $20 and from then on, it has been about $20.
You can go down the list and look at DNDN and others and see the same press releases of stock offerings before the stock really took off. HGSI has done public offerings since I got in the stock in 2006 and look at the yahoo message board posts so similar to ARIA message posts. Same bashers, same pumpers, same everything.
None of this means ARIA is going to take off, but when I got into ARIA in early 2009, the stock price was $1.50-$1.70 and today it is $3.70. Yet, everyone here keeps trying to bash because of what the stock was 10 years ago. I feel for every one of those who got in too early and now just spill venom or just feel cheated. Many of the shorts here are just telling lies in hopes the stock goes down.
Bottom line is this... ARIA's upside is way higher than the downside risk in my opinion and I am buying more. This new secondary offering was well timed, not poorly timed.
One more tidbit. In the years leading up to DNDN taking off, they did secondary offerings and they were also told by the DMC to go back and change the dosages. The stock dropped and everyone was bashing. ARIAD was told by the DMC to continue without making any changes to the dosages.
To me, ARIAD is on the verge of a major price increase - maybe $5-$6 by year end and maybe $10-$15 by May of 2011. Sometimes I wish it would have some negative news or less positive on RIDA because 534 may be a super drug from early indications. The fact that it has done more for people even with mutant forms of the disease when everything available today can't stop it is beyond significant.
People today taking Chemo and other "standard" treatments apparently had less side effects from the latest Merck/Ariad press release. Yet, the positive was the "standard" treatments were half as effective for survival.
We can sit and spin this 100 ways, but I think the people at Ariad and Merck and the timing of the latest news is very positive. One way to find out is to come back over the next several months and see the price action and daily volume and compare it to the previous months volume and price.
The record reflects that this CEO's Dilution Announcements are poorly timed,don't maximize the potential capital obtained and are done without any consideration of the retail investor...He does not even seem to care about the perception that he does not know what he is doing or worse the perception that he manipulates news in the process and leaves folks feeling he is a little bit of a slimy character...
It's certainly not a vote of confidence regarding SARCOMA from the CEO;;;
Can you explain the rationale at the heart of his strategy to me... They do not need this capital right now..why is it not a better strategy to build on today's momentum over the next couple months with RIDA SARCOMA excitement building into the stock as it moved forward and sell some shares then....Unless in his mind Succeed's chances are not much better than even odds...the filter through which I am seeing this action tells me he is unsure about RIDA SARCOMA and he is the CEO of the company..Tell me why that should not give us all skepticism about SARCOMA results..
Succeed must be hurting otherwise why not hold off and get 7-8 $'s a share 3 months from now...
Ariad's Compounds Deserve a better father than Harvey Burger------
A change in leadership is needed here..
His timing is simply the worst..whenever this stock is building momentum and folks are really getting interested... he dilutes...You cannot tell me that it had to be announced today... Incredible ...and ...Absurd..
the only way this makes sense is if the Rida Sarcoma Trial is not going well and therefore he anticipates a problem with valuation at the time he will need cash due to Rida failure...it's either that or this guy is an idiot..
BIOTECH HEDGE is a Market Moving Data Gatherng Savant....
I would anticipate additional buying before the bell and through the close tomorrow...but whether it comes or not....
Sounds like most here are going to hold the positions they've taken through the Rida results (60 days or so away)..It's not easy to be patient for 60 days ... I'm taking a break from obsessing....my line has been drawn and I'm gonna hold it...there really are some very bright and articulate folks on this board who have helped me and many others incredibly as we've attempted to evaluate what action to take investing in ARIAD...Good luck to all of you
THANKS AND ALL THE BEST TO YOU AND YOUR FAMILIES
My gut says the opportunity to manipulate the stock as a means of buying up low cost shares is waning...the final efforts to buy at these levels will be intense as positive news approaches and the ability to control the rise in share price is lost (OK diminishes) ...There will clearly (m-o) be fewer and fewer chances to buy ARIAD Stock below $4.00 as time goes by...so "they" are taking their shot..That's fine...Let um..I'm holding at least through Ponatinib final ...so todays price doesn't really matter much..
Maybe in terms of stock performance today... the characterization is understandable...I have a hard time using that term for a company with as many significant self discovered compounds as ARIAD...the added dimension of a company that is trying to help very ill patients and the families that love them makes being invested here rewarding on many levels. So I would say the share price action today sucked and leave it at that...
No Options expert but I think it's positive indication to have significant calls purchased today with a rising premium and strike prices of $5.00 for January 2011 (784 5's at 55 cents premium) as well as 467 $5's for February...even a few $6's for February..
I'd add that I have a greater level of confidence that Rida will find itself approved for other indications and be a bigger money producer over the course of the next 8-10 years than most imagine..
I agree... I don't think the sentiments toward Rida in Sarcoma on this board accurately reflect the population of investors in the stock. I would imagine that the overall assessment is more like 55 - 60 % positive....Which I would say based on all the data is about right...I would love to say it's 80 to 90 but as you say almost nothing in Biotech has those type of odds...Good thing is we will know very soon and the guess work will be over...Hope everyone has a good weekend..
Four dollars is the point where the stock begins to become marginable (25%) with most investment firms...and Five dollars is another point where additional capital can flow due to certain fund guidelines....Perhaps the folks on the other side of this trade have motive to slow things down..hard to know why things are happening the way they are..
Watching the bid and ask..everytime we reach or approach 3.95 suddenly we go from 2 or 3 thousand at the ask to 40,000 plus..Not sure if this is someone who suddenly wants to sell as the stock gets to 3.95 or someone trying hard to keeep us from moving beyond it..But it has been happening repeatedly throughout the day...
"rida/endo news at the end of the month"
Do you know the name of the coference and date of the endo presentation?
What is the date/name of the conference where you are expecting the formal announcement of the endometrial results...thanks in advance..
Though its a brief and small scale trial it seems very positive. Out of 11 patients who stayed on study 7 mostly sarcoma sufferers had positive responses of either clear tumor shrinkage or stable disease....It is at least a small window into the effects we hope to see in the phase 3 Sarcoma trial..
RIDA
Given the long term importance and near term impact of the RIDA Phase 3 outcome..I was hoping we could discuss/review the technical basis for anyones positive or negative views..Right now I don't see anything more important to the stocks near and medium term performance..Last week I had thrown out for discussion any impact the secondary endpoint of overall survival may be having on the longer time intermval between the 1st and 2nd interims in comparison to the 3rd and final data analysis. No one responded...
I am certainly a novice..so it may be that some think the topic is not worth talking about at this point ..
Rida Results
In reviewing median survival figures in patients with metestatic sarcoma I noted that 90% do not survive beyond one year.Wondering if the longer delay between interim 2 and 3 may relate to the secondary end point of overall survival built into the study.
This was important to the FDA as far as trial design... but less so to ARIAD. This may be the cause for delay...evidence of delayed progression is likely to be found earlier than the secondary end point of overall survival...so perhaps that explains the longer interval for results that we are currently experiencing. Any thoughts?
Fixated on Sarcoma Trial
Was just reviewing median survival figures in patients with metestatic sarcoma and noted that 90% do not survive beyond one year....I am wondering if the longer delay between interim 2 and 3 may relate to the secondary end point of overall survival built into the study. I know that this was important to the FDA as far as trial design but less so to ARIAD. Anyway I was thinking that this is what we may be delayed by...evidence of delayed progression is likely to be found out earlier than the secondary end point of overall survival. it was important to the FDA and obviously the SARCOMA community so perhaps that explains the longer interval for results that we are currently experiencing. Any thoughts?
I am just trying to prepare myself for the possibility that we may be in for a longer wait for a significant move up...I need to be more patient...I got excited about the lileyhood we could roll from one positive RIDA application to another...then start getting news on the Ponatinib results in the different cohorts and got lost in dream land..Everyone has the right to dream..but I think I need to reel it in and fous on what's in front of me..:)
Are you saying that you did not notice that Harvey went from seeming optimistic about a second interim forming the basis of a drug app to talking hesitatingly about whether it would pass the final..Are you saying we should ignore this change in the CEO's own outlook..