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>Is anyone here excited by this?<
I have to admit I don't see the great excitement over DeCode. Their CEO has been complimented as a visionary. It is hard to argue that he is, at the least, an extremely competent scientist. But I think that most of the excitement about the company is excitement over the CEO.
I don't see what is so different about DeCode's genetic linkage studies versus those that are happening every day. They have access to the Icelandic population, which is both an advantage and disadvantage in my opinion. The advantage is that they will have less "scatter" in the genomes that they're surveying and will therefore be able to pull out reliable signals from smaller populations. But on the other hand, they are also at the mercy of features unique to the Icelandic population that may or may not be relevant to disease. This is especially true in the cardiovascular area where diet plays such an important role.
Also, different populations may have different haplotypes (they found this for one CV risk marker) and this may confound drug discovery.
Also, I have an admitted bias that I think the CV arena is for big pharma only. I don't believe that an unprofitable biotech has the resources to design and execute clinical trials that will reliably validate their CV drugs.
One plus about the company is that they do appear to be willing to change and evolve. Their first inclination was to do the mapping, find a risk factor, and then comb big pharma for tossed out drugs that target the protein of interest. That strategy had a big flaw, in my opinion, because any success would have meant that the next time decode comes knocking, big pharma would have been much more restrictive on the licensing terms. Now they appear to be generating their own new chemical entities. That should help reward their investors even more.
What kind of drug?
Oncology? Inflammation? Cardiovascular? Gaucher's disease?
Honestly, the numbers look just like the ones in the ASCO 2004 press release.
I don't follow it too closely, but I thought the issue was that Israel was allowing their domestic companies to infringe patents if the patent holder was uninterested in marketing the patented drug in Israel... is this still the situation?
Celg calls them all immune modulators. I think they stemmed from the preclinical work that the company did on thalidomide, working to try and preserve the relevant anticancer activity while toning down the side effects. I'm not sure that the target has ever been revealed, or if it's purely a biological assay that they used to refine these chemicals.
Celgene may have refined out the teratogenicity from Thalidomide, but Revlimid still suffers from a rather robust ability to induce myelosuppression. So it is far from benign. It has also already failed a controlled trial in melanoma, so its prospects in cancers beyond multiple myeloma are not particularly encouraging so far.
There is also data for Revlimid use in myelodysplastic syndromes. This seems to be a hot area, and Revlimid does have rather striking efficacy in a subset of these patients. However, dosage appears to be of interest to many investigators due to the myelosuppression that the drug can cause.
My bet is that it gets on the market. However, Celgene's tendency to continually go after multiple myeloma may present a possiblity of cannabilization (gain revlimid sales, lose thalidomide sales). It should help their bottom line, but i don't see it as a blockbuster by any means. If Revlimid can't show efficacy in a solid tumour, i would bet that the "imid" line of drugs from Celgene have hit the wall...
(actimid is next and is being tried in... you guessed it... multiple myeloma)
Yeah, the spin starts immediately.
It's somewhat shameful to admit, but I was so untrusting of Bianco and Rosenwald that I only had 50 shares coming into the Stellar trial data release! It's kind of a joke to buy just 50 shares, but it's obvious that I could not bring myself to trust these guys at all.
And again, these Rosenwald stocks always make a big splash about the time of data release in order to send the option premiums soaring. It's always been my position that these "guys" are selling the options left and right... and making a killing. I don't think this action in Rosenwald stocks (Gnta, Ctic) is a coincidence and the SEC should look into it.
OSIP noted that at ASCO they will present the data for the patients bearing mutations in the BR21 trial. That should give us a couple of data sets to compare. My position is that Iressa should remain on the market until there is clarity on Tarceva's effect (if any) on this subset. If Tarceva appears to be equally effective, I can see AZN pulling the drug (or not marketing it actively) because the economics would clearly be working against them.
If Tarceva does show similar efficacy in the mutant subset, I wouldn't be surprised to see AZN allow a smaller niche pharma to sell Iressa in return for royalties.
I think pcyc is another one of those rosenwald stocks... exhaustion has weakened your defenses and the shady stocks are lodging in your head.
Perhaps a Genta investment is in your future?
And yes, i remember us previously discussing non-inferiority. I just thought you wanted some more.
I believe Pharmion does the marketing of thalidomide in all areas except North America, Japan, China, Taiwan, and Korea.
I'm not sure which Genzyme product walldiver may have been referring to...
The problem for the combination at this point is whether there is a time threshold for when the PML risk rises substantially.
In other words, if people had a higher risk of full blown PML after two years of combination use, would I as a chronic disease patient risk 6 months combo use? 1 year?
We'll see how this shakes out, but it appears to me that combo use is going to have a very difficult time even if these two events are deemed unrelated to therapy. For the time being, it appears that patients depending on monotherapy use are the innocent bystanders.
doesn't the "delta" in the non-inferiority analysis introduce an additional variable versus a superiority trial?
The problems in the non-inferiority trial stem from the need to model more parameters than a superiority trial, thereby introducing additional uncertainty (versus a superiority trial) as to whether or not the initial assumptions were effective. The sponsor and the FDA have to agree on what % of the control arm's benefit need be retained; introducing this additional variable adds a level of complexity and uncertainty into the trial design. Anytime there is an additional uncertainty, that is also accompanied by the need to treat more patients in order to accurately power the trial to measure the desired outcome.
This coming from ctic's mention earlier today?
SRA looks like a good short. eom.
I hope for patients and investor's sakes, the use of combo is more prevalent than I had initially thought.
My sympathy to anyone getting really hit hard on this news. Even the best investor can not prepare him or herself for such a scenario.
They note that about 3000 patients have taken Tysabri in one form or another. They note 2 deaths in combo with Avonex in MS patients. I suspect patients taking Tysabri and Avonex are easily less than 1000, if not less than 250. That would approximate the prevalence of death in combination therapy at almost 1%. Sounds pretty serious to me...
At first I was wondering if this is a buying opportunity for a short term pop? But I'm staying away.
I think you're confusing Rituxan with Bexxar.
Rituxan is an anti-cd20 antibody. Bexxar is an anti-cd20 antibody with radioactive iodine attached to it.
Guess which one sells more?
>so the plant buildout does not increase the risk unduly.<
Completely agree. The cost of manufacturing has no bearing on 9902B.
Presumably the current manufacturing capability of the company will be sufficient to support the BLA.
The manufacturing issue was just something that stuck in my head with regards to the company's cash balance. Just trying to decide if the company will need to go to the capital markets upon approval of Provenge...
that's what it was!
Thanks urche... i don't take notes, so these gaps of forgetfulness show up occassionally. I appreciate you taking the time to fill me in.
Damn my dndn knowledge is cursory...
but i remember reading here, either directly or through a link to the yahoo board, that the cash that DNDN had on hand was really already "spent" on the manufacturing capabilities that they would require to manufacture provenge... any recollections? Does that make a tangible dent on where or when dndn is considered "cheap"?
I'm tempted to pick up some shares if i can get them on the cheap (what else is new?), and then hope for a run up prior to 9902B data or BLA filing... similar to how i've played ctic.
fwiw, it's sometimes nice to be able to think aloud. hope it doesn't bug anybody.
Interesting... thanks!
I'm also curious what the survival comparison would have been like had the trial been equally enrolled in both arms. Maybe I'll do some asking around with people who can at least describe it to me in theory.
One last question for you: is 9902B 1:1 randomization or is it 2:1 like 9901 appeared to be?
>Dr. Gold made a public statement this weekend that DNDN is strongly considering opening up the 9902B trial to all Gleason scores by amending the SPA. <
The data you posted for 9901 appears to make that move a necessity (?).
As it stands, do you think the 9901 Gleason 7 or less data are impressive or suggestive of success in 9902B as it is currently designed?
Also, DNDN appears to take multiple prespecified looks at the data. Do you have an idea of what p value penalty they pay for each of these looks?
naive question re: dndn
If I'm not mistaken, the confirmatory trial 9902B is enrolling patients with gleason score of 7 or lower.
From the data you posted re: 9901, this group actually was the least impressive of all. The 6 or lower group is no different, so it looks like it's up to the gleason = 7 group to pull out 9902B?
>I liked what you posted on GNVC on the yahoo board (msg 11689 and also this other msg at 11684) about the incidence of thrombosis in pancreatic cancer.<
To be as transparent as possible, I sold my gnvc position today simply because I think I can reposition at a lower basis. Even if/when the TNFerade hold is removed, I don't think the share price will go well north of 3, if at all.
again, fwiw...
fwiw re: ARQL...
Wasn't an impressive CC by any means. I sold my position this morning. A couple of red flags from my point of view:
1) Reading between the lines, the results from the monotherapy trial aren't looking good. They'd previously suggested that they hit mtd at 550 mg/m2. However, it's clear that at the prior dose level, 390 mg/m2, they didn't see any significant activity. Now they're left to mess around with dosing schedules for doses between 390 and 550 to see if they can push the responses and, presumably, the amount of drug getting into patients.
2) The second generation E2F program, named 550RP, is much further from IND than i thought. They're still at a very early stage of simply deciding what type of new chemical entity to generate... one comment was that it could even be a polymer of sorts of arq501. Not exactly encouraging from my point of view.
3) There is another financing being telegraphed. Although this is not a surprise for a company at this stage, their plan of ending 2005 with about 70 mill in cash suggests another 10-20% dilution. Weighing that dilution against reasonable expectations for drugs in the clinic suggests a flat year for the share price, in my opinion.
4) I'm starting to get a bit of an uneasy feeling regarding Hill. He couldn't even give a straight answer as to whether or not they've submitted an abstract for aacr or asco. Come on...
My impressions only...
Clearly english isn't my first language.
Irregardless, I'll accept my grammer mistakes as long as my holdings do good.
>Maybe "poor" in poorgradstudent is more important to you than I first understood.<
It's near and dear to my heart. Although the jokes and insults based on it have become very stale. If no one is going to be bright enough to generate new material, i may have to change the alias.
>I'm presently down a small amount on AXYX, but I had my cost down because I had traded in and out a couple of times and started buying in the low 3's.
I'm presently up with RGEN, CRIS, and AEZS. I've traded in and out of a couple of others at about breakeven.<
As rk pointed out, i think that there is a distinction between trading biotechs and recommending biotechs. You can trade in and out of any biotech and make money, but that doesn't mean that the biotech itself was a good recommendation.
For example, you could have made buckets of cash on Genta's trading gyrations and option premiums. However, it was and still would be a horrible biotech company to invest in.
If I was to pay for a service, I would want one where they tell me the companies and the drugs they believe will get approved, a thorough preclinical detailing of the drug (none of this "their drug is the key that goes into the enzyme's lock" crap), and a constant, up to the week survey of the medical results emerging from public and private companies, data presented as abstracts at meetings and peer-reviewed papers from Pubmed.
OSIP's expenses are out of line with their stage of development, in my opinion. If they're not careful, they're gonna pull a mlnm and find that it is easy to bloat expenses but not as easy to curtail them.
In my opinion, they are being relatively aggressive on the clinical development of their pipeline with two c-kit/kdr inhibitors (one with newly approved IND, another as backup in preclinical), along with 1 current clinical and 3 developing preclinical compounds through their diabetes venture. But again as mlnm has shown and as many biotech investors will (must?) appreciate, many candidates in clinical trials does not necessarily equal a robust pipeline.
They did move up their projected profitability timeline by about a year, so that's somewhat encouraging. Nonetheless, it's still about 6 months behind their initial "18 months to profitability following launch" plans of earlier.
I think OSIP is a perfect stock for which to sell covered calls over the next year.
>For OSIP, this line item also includes reimbursement by DNA for a portion of OSIP’s R&D and marketing expenses.<
I was also under the impression that OSIP is responsible for drug manufacturing and receives a level of reimbursement from DNA. I'm unclear if that is included under the "R&D" or "marketing" umbrellas. If it is, apologies. If not, adjust your spreadsheets
>Anyone else willing to pay Dew for a specific transaction record into the future to compare with other biotech analysts??<
No. But if people are willing to pay me, I'll do it.
>1.Whats wrong with the idea of a cocktail of Erbitux + Advexin;
reading the above leads me to think Erbitux might enhance the
performance of Advexin<
There is absolutely nothing wrong with the idea.
The only limiting factor to that idea is that somebody needs to actually do the trials and test the expectation. Oncologists don't appear to be overly cavalier, and it is unlikely that there will be widespread adoption of a novel combination therapy (advexin + erbitux, for example) without some strong, convincing clinical data... preferably of the randomized kind.
>1.What gives with the NDA since they published this data 8 months
ago?<
It's my understanding that the company was advised to let the survival data from ASCO mature out to another year. So they'll have some rather sturdy survival data at the time of sBLA submission.
>2. Since the trial compares with radiotherapy and not other drugs
such as MTX or FU5 how can we glean from this any useful comparison to the T301 trial?<
It is hard to make a stringent comparison when different drugs are being tested. Both IMCL and INGN would have to be rather comprehensive in their data release so that investors can decide whether a comparison is valid.
>3. Does IMCL have another PIII I havent found<
I don't follow imcl all that closely. To my knowledge, there is not another trial but I could certainly be wrong.
ok, i gotta ask because it's eating me up...
If you don't know how the subgroup was clinically defined, then how can you have any idea as to whether or not the results with advexin in this subpopulation are better or worse than the current standard of care?
Yeah, the burn rate isn't great, to say the least. And I'm never happy when management has egregious compensation.
That's life in biotech, i guess.
I don't own any shares. I don't have nearly as much capital as the others on this board, so I need to be a little "choosier" in the very early stage companies that I invest in. I feel no urgency to get into ARNA at this time.
If I had the cash, I'd buy some and keep watching.
I like them.
GPCR's are a diverse set of targets and have wide applicability. Arena has some collaborations (notably merck) and their net cash position isn't bad.
I think there are worse, early stage biotechs out there... of course, that might not be saying much
I could look for references as well, so don't trouble yourself with that... i'm just curious how the subgroup is clinically defined. Do you have that info handy?
Thanks
>It seems that the 31.4 month median survival among patients with objective
responses is better than the current standard of care by an order of mangnitude.<
That implies that you know the typical median survival range for patients in this subgroup. Could you tell me that that range is, and how the patients in this subgroup are distinguished?
As I've not been able to find out the distinguishing characteristics of this subgroup in question, i've not been able to determine (from the literature) how this subgroup historically responds to treatment.
exactly! Caveat emptor.
None of the reasons i've outlined guarantees that this drug will outright fail in the clinic or at the fda. However, the company and its actions tell absolutely different stories.
>I just dont see any basis in the public record for believing there is
some conspiracy to hide some insufficient or unsatisfactory
result here.<
Forget outright conspiracies.
So what do we have?
A phase III trial that is measuring survival, 240 patients total in 2 arms. First patient accrued in june of 2000, so 56 months ago. If this trial is not fully enrolled yet (no basis not to believe the company), then they are accruing at an atrocious rate of 4 patients *per month*!!!!
That is either gross negligence on the part of ingn, or they no longer care about the outcome of this study. If it is negligence, then that doesn't bode well. If they no longer care about their phase III trial measuring survival, that's because they have seen the writing on the wall with respect to this trial. Remember that this is an open label trial.
Now, we have Pazdur at the FDA again talking out against accelerated approval using surrogate endpoints.
INGN, despite having the T301 trial measuring survival, is saying that they are looking to file for accelerated approval using surrogate endpoints, and plan to finish the filing by year end 2005.
If this 301 trial was looking good, or ingn was indeed interested in its outcome, why would they file for accelerated approval based on a mixture of phase II trials that use surrogate outcomes? Especially when they know that imcl is poised to file for the same indication but with survival data. Survival data trumps surrogate endpoints (see iressa versus tarceva), so it doesn't appear to be a great move by management to avoid putting its best foot forward (t301 survival results).
Now, even when ingn files based on surrogate markers, the FDA is going to want a randomized study to validate the surrogate endpoints that were measured in the phase II studies. Well, conveniently ingn has the t301 trial looking at survival... so what do you think the fda will say? Show us the t301 data.
My bet is that management knows that the T301 trial has no chance of successfully meeting its primary endpoint on an intent to treat basis. They're leaving that trial open so that they don't really have to do an official analysis of it, and thereby trigger disclosure requirements.
Will the management of an unprofitable biotech ever directly tell you that they're shelving a phase III for their lead compound cause it's not looking good? Rarely, if ever. They're more apt to give out very little information (case in point) and let the memory fade.
So no, i do not have any smoking gun to show you that this trial has failed or that management has given up on it. I never will until the trial results come out. However, all their moves to date (accelerated approval, 56 months patient accrual and counting, generally poor disclosure of clinical trial data) give me as clear a picture as I need.
You can believe me, or call me a quack. Don't matter much to me
However, when this all boils down, i'll be here to face up to my conclusions regarding the t301 trial, whether they be right or wrong.
sorry, are you saying that the company is confirming 240 patients *have* been enrolled, or that 240 patients are planned to be enrolled in t301? The sec form you copied states that 240 are planned.
One thing to discern clearly is whether or not patients are receiving drug treatment in addition to surgery, or if the cancer is inoperable.
GBM has about a 6 month median survival time if it is inoperable. From your comments about the YMI data, the patients were eligible for surgery. Then the question to be asked is what percent of the responses are from the surgery?
The means you provide look impressive. Although hard to compare to the median numbers routinely reported, at least they had 30 or so patients so that one or two outliers wouldn't cause as dramatic a shift as if they had 10 patients.