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When will the SCOTUS decision on the status of appeal be posted?
Prefer not to explain too much, but nothing in his post make me think he understands whats going on. Just a bunch of generic copy & paste of modified company statements. Like most Seeking Alpha articles, authors(~95% or so), they don't get the implication of decisions or the significance of clinical risks the company is taking on.
For example, he doesnt even mention the risk CLDX is taking in the Ph3 with CDX-011 with moving the drug up several lines of therapy and doing it in only TNBC or whether or not the company has a solid assay for GPNMB. Also fails to mention the ongoing Phase 2 of Rindo in glio +Avastin arm is basically up in the air since those Phase 3 trials failed on OS (presented at ASCO'13)
This author has no idea what he is talking about. That much is clear
Actually think several is a bit of an understatement. I think it's over 6 by my last count. Just the beginning
I don't think it does more than half that number. This writer also seems to forget the FDa never signed off on these endpoints. Expect an AdComm.
"Non-rapid progressors" doesn't really qualify in my book as a valid subgroup.
Still relatively cheap, obviously have a lot of catching up to do and they don't have nearly as broad of an immuno-oncology pipeline as Bristol. It will be pretty interesting to see more durable data later this year and the data in lung.
I was at the Bristol event last night and came away very impressed; definitely have a broad vision.
I posted a slide from the Roche presentation on Zelboraf + PDL1, doing a Phase 1/2 I believe(very early on)
http://twitter.com/chasingthealpha/status/341239565161492480/photo/1
Its a subtle point a lot of people are missing. Well over $5B in sales are priced into BMY *now* for Nivo, while MRK has well under $1B and wasn't predicted to reach market till 2017. I expect to be approved much sooner than that.
I'm not sure I agree with you for a few reasons. First and for most, we haven't see enough LT followup (OS / duration data) on Merck's drug but the ORR does look superior to Nivo monotherapy.
Also some things to consider about the Yervoy + Novo combo
- IPI + Nivo does have AE issues that not all oncologists want to deal with. Actually during yesterdays melanoma session a well-respected questioner referred to Yervoys AE profile as horrendous.
- The affordability and cost of IPI + Nivo will be an issue.
Still way too early in the race to claim Merck is done. Actually think their asset is the least appreciated with the most upside from current consensus.
ORR was similar to Nivo/Yervoy at selected dose. Very good data. I sat next to Adam F and Mark(at ISI), all very impressed.
Roche data was ok(in a relative sense to BMY/MRK). The biomarker data on using PDL1 staining doesn't help them since it doesn't appear to be all that predictive.
I have heard that their data is really good
They really need to focus on their PD1. BTD could help them shave some time off the lead BMY has (presuming no snags).
Trial is listed here , unfortunately it still has RBV in both arms
http://clinicaltrials.gov/ct2/show/NCT01717326?term=Merck+HCV&rank=34
MRK should have data later this year on their PI/NS5 combo, might make it for AASLD.
Somehow I think anorexia/cachexia is not as big of a deal as the autoimmune disorders seen with these. MRK's ORR numbers are quite impressive.
I have seen a number of patient posts in melanoma and RCC. This drug has truly changed a number of patients lives.
I suspect consensus estimates for Lambrolizumab (anti-PD-1) are much too low. Analyst meeting at ASCO on Sunday will shed more light on their strategy to catch up.
But at what cost? I tend to agree with John LaMattina on this. Think their whole future will depend on outcomes study.
http://www.forbes.com/sites/johnlamattina/2012/03/26/new-cholesterol-lowering-drugs-will-test-the-future-healthcare-system/
Agree, they have a lot of promising stuff, especially their own PDGF candidate to add to Eylea.
I'll admit my comment was a bit like shooting from the hip, since I hadnt studied their pipeline in very close detail. But I still dont necessarily see PCSK9 or their RA drug as big ticket items.
At the time someone asked
You'll have to let me know when I said this, since I don't recall saying it recently.
ONTY will be. Stimuvax toast and their Pi3K stinks.
No, there are no relevant bavi abstracts at ASCO from the front-line study.
http://abstractsearch.asco.org/cgi-bin/ts.pl?index=442064&query=bavituximab&opt=any&submit.x=-879&submit.y=-456
You do realize this means they only expect to see marginal improvement in OS? FDA had very little faith in their Phase 2 data.
Good luck finding any leading KOL who will put his name next to this complete POS company. I suspect this trial will have very slow enrollment. Everyone wants to be in the PD-1 trials, not some futile study being run by a company with a history of hyperbole and no robust data.
Notice company is still hiding the front line OS study data.
My comment didn't refer to that. Just their overall strategy in NSCLC.
Notice the absence of any prelim sales numbers.
I think ARIAD trying to rush it a bit in NSCLC, due to competition.
I dont buy it that it was a typo. Took them 4+ hours to notice a pretty significant typo re Q&A? Imagine Harvey got enough pissed off fund managers telling him it was a piss poor idea and they re-thought the decision.
Probably somewhere in between.
I have read the note and it has it's issues(main worry is hyperbole). However, although it might be a small survey, these appear to be some high volume CML docs, so dont think they would overstate things(unless Favus is doing that).
I would be worried if some of these anecdotal comments on AEs were true and show up in the FDA's AE reporting service.
Below is the note for those wondering
"What’s New: We are awaiting an FDA response to our request for the first set of Iclusig serious adverse events since US approval. We got impatient, so this week we performed a survey of US oncologists who use Iclusig in CML. While we planned to include 30 oncologists; we have taken the unusual step of stopping our survey early because we found a large number of serious adverse events that are not consistent with frontline CML use. Since many patients take the same CML drug for years, tolerability is an important issue for patients and oncologists. Our summary findings are:
1. Our survey includes 13 oncologists who are treating approximately 840 CML patients and have used Iclusig in 77 patients since FDA approval in December, 2012. Of the 77 patients treated with Iclusig, 39 patients (51%) were rollover patients from the continued-access program, and 10 patients (13%) have already stopped taking Iclusig (suggesting a rapid drop-out rate).
2. Serious side effects include non-reversible significant liver toxicity, pancreatitis, severe acute hypertension, heart attack, stroke, TIA, digital ischemia, and gastrointestinal perforation (Figure 6 & 7).
3. Our small survey found 26 patients on Iclusig who had abdominal pain that required medical attention/evaluation and 21 patients who developed pancreatitis.
4. Iclusig is getting pigeon-holed as the drug for T315I mutation (extremely rare), while Bosulif has a broader appeal in heavily pre-treated CML (Figure 11). This use pattern is different from ARIA’s recent description of the US launch.
5. Oncologists report that ARIA’s Iclusig sales pitch (Figure 12) emphasizes the safety profile and duration of responses; both issues appear at risk just a few months into the US launch. Oddly, ARIA salespeople are mentioning the ongoing frontline trial of Iclusig versus Gleevec; while not illegal, we fail to see how this fits into on-label sales activities.
6. Oncologists in our survey report using Bosulif in 32 patients since FDA approval in September, 2012; only one patient was on the continuing-access program.
7. Negative on discontinuation trials, positive on generic Gleevec: 70% of oncologists in our survey do not expect treatment discontinuation to become a viable strategy in CML, or believe it will be applicable for only a small number of patients. Recall that a bull argument among ARIA holders is that frontline treatment with ponatinib will provide deep responses in CML, which creates an opportunity for treatment discontinuations. The oncologists in our survey expect frontline Gleevec use to rise in 2015, when Gleevec goes generic in the US.
Our View: The more we learn about Iclusig, the less it appears to be a frontline CML drug. As the number of cases of liver toxicity, pancreatitis, abdominal pain, severe acute hypertension, heart attack, stroke, TIA, digital ischemia, and gastrointestinal perforation rise, investors’ faith in Iclusig will fall, and so will the price of ARIA shares. Iclusig has a very small role to play in heavily pre-treated CML patients with the T315I mutation (extremely rare); as time goes on, that observation is becoming obvious. Don’t be the last to know…"
That's fine and dandy, but think too many got comfortable with this notion that Iclusig would just sweep up 1L and 2L, despite head-to-head data. Safety matters greatly to patients and community oncologists.
I do get the feeling Harvey is rushing it a bit. As biomaven said, they probably could use a little more work on dosing strategies if they want front-line and second-line.
Come off it, sell side reports you have referenced in the past often were surveys from mystery physicians. Skew and bias rampant throughout on both sides. Notice those super bullish sell side survey never disclose payment amounts to participating doctors.
We all want trials to work out, but that's just not the case. Its insulting you would infer what you said, but PPHM longs have little class left after everything that's transpired.
Thanks for posting a 2-year old quote. Young and naive then. You learn from your past so you're not doomed to repeat it. I quickly caught on that Peregrine was not in the business of doing serious work.
I guess it depends on who you trust. UBS spoke to management and they said 1 month. Cowen confirmed short duration as well.
I seriously couldn't stop laughing for 20-30 minutes after I read this. Now I am starting to get worried that someone from FBI/Langley like Matt Damon is going to knockdown my door.
Buying BIIB here would be almost a merger of equals at current valuation!
Stock was down because many had hoped they'd have a late breaker at CROI. Data wasn't ready.
What in particular did you find so boastful? I agree their language has changed. Very 'ambitious'.
I think there are some parallels in how SGMO/Shire approach rare diseases and the recently approved Glybera.
http://www.nature.com/mt/journal/v20/n10/full/mt2012194a.html
The Medicines Company is licensing the rights to a powerful type of cholesterol-lowering drug from Alnylam Pharmaceuticals, entering one of the hottest races in the industry.
The drug, known as ALN-PCS, inhibits a protein in the body known as PCSK9. Such drugs might one day be used to treat millions of people who do not achieve sufficient cholesterol-lowering from commonly used statins, such as Lipitor.
The Medicines Company will pay $25 million initially and as much as $180 million later if certain development and sales goals are met, under the deal expected to be formally announced Monday. It will also pay Alnylam, which is based in Cambridge, Mass., double-digit royalties on global sales.
[Seems like quite the fire sale on ALN-PCS]
http://www.nytimes.com/2013/02/04/business/medicines-co-licenses-rights-to-cholesterol-drug.html?partner=yahoofinance
Wasn't BAX Gammagard purported efficacy in a tiny subset of patients(n=4)? Nuts they moved this into Phase 3 after only doing a ~20 person Phase 2.
Apparently CEO told many this back around AASLD'12
From Alex To -- CLDX: Statistically Significant Overall Survival An Upside Surprise
• At the San Antonio Breast Cancer Symposium on Saturday, Celldex presented the mature Phase 2 data on CDX-011. In triple negative breast cancer patients who were also high GPNMB expressers, the study achieved statistically significant differences in both overall survival (OS) and progression free survival (PFS). The median OS in the CDX-011 group was 10.0 months (n=10), while the median OS in the control group was 5.5 months (n=6). The p value was 0.003. The median PFS in the CDX-011 patients was 3.0 months (n=12), and the median PFS in the control group was 1.5 months (n=6). The p value was 0.008. The control group was the investigator's choice of salvage therapy. The patient population was heavily pre-treated, and the study was conducted as last-line salvage therapy.
• In line with a Phase 2 exploratory trial, the data set is naturally small. Therefore, one should exercise caution in interpreting the statistics. However, the rest of the results in this Phase 2 trial overwhelmingly corroborate the impression that GPNMB is a highly promising new target for the treatment of breast cancer and that CDX-011 is a highly efficacious drug in this setting. Here is the key supporting evidence we gleaned from the trials. (1) In all GPNMB high expressers with all receptor subtypes - meaning not just the triple negative breast cancer patients, but also HER2+, or ER+, or PR+ patients - the median OS in the CDX-011 group was 10.0 months (n=22), while the median OS in the control group was 5.7 months (n=11), p=0.18. The PFS comparison was 2.7 months (n=27) versus 1.5 months (n=11), p=0.14. This piece of data not only correlates with the triple negative results, it also points to the promise that CDX-011 will not just be a drug for triple negative patients only, but will be able to address the 22% of all breast cancer patients whose tumors express this antigen.
This is a patient population about the same size as that of HER2+, which is the target for Herceptin. Roche (ROG.VX) realizes $6 billion annual sales from Herceptin. We view this as the market opportunity for CDX-011, not counting the other cancer types outside of breast cancer that can potentially benefit from CDX-011. (2) There is a nice correlation between the degree of response to CDX-011 and the degree of expression of GPNMB, which again proves the validity of the drug and the target. In all patients in the trial with less than 5% tumor expression of GPNMB, about 13% of the patients achieved a partial response or unconfirmed partial response (PR/uPR) after receiving CDX-011 (n=34), while PR/uPR in patients with more than 5% GPNMB expression was about 19%, in patients with more than 10% tumor GPNMB expression was 27% and in patients with more than 25% tumor GPNMB expression was 32%. There is no such correlation in the control group. (3) While the duration of response in triple negative patients is not overwhelming, the OS and PFS results make the concern over the duration of response moot. This is also corroborated by the findings in disease control rate: 75% versus 25% in triple negative patients with high GPNMB expression, and 64% versus 38% in all GPNMB high expressers.
• We think these Phase 2 results clearly demonstrated the promise of CDX-011. A partnership with a larger company in the near term will be beneficial. While it is entirely feasible for CLDX to run a small registrational trial in triple negative patients and to get the drug on the market as soon as possible, to realize the commercial potential of this drug, a large comprehensive pivotal program to explore CDX-011 in all GPNMB high expresser breast cancer patients, from the salvage setting all the way to front-line combination usages, plus exploring the drug in other GPNMB expressing cancer types, will be needed. With this data set, we will be surprised if no partner steps up to the plate.