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VVUS:
For those interested, Adam Feuerstein says Qysmia scripts were 933, up 106 from the previous week.
Re: To be honest with you, I would be looking for a troponin receptor on the platelet
Luckily that's not a remote possibility
The majority of stem cell strategies to date:
Inject stem cells + ? = magical migration of the cells to the correct location and their magical differentiation into the appropriate cell type
SRPT:
SRPT:
I mumbled about this on twitter but I think the important observation about dystrophin production would be if the protein is actually incorporated into the costameres. Only then is it functionally meaningful.
The report that you get increased immunofluorescence is vague and doesn't necessarily demonstrate incorporation.
OT:
Clearly you've been following ARQL for a long time, so I have to ask if you're trolling us by constantly misspelling MARQUEE?
What iwfal said.
I was just going to ask what's the point of having a putatively prognostic target if it doesn't help you decrease enrollment by increasing signal:noise in your trials?
Charts:
Sounds to me like you need to do a prospective study of charts and how they predict phase III outcomes. All this retrospective data mining could lead you astray.
aria:
ARIA:
I don't disagree that the data look good so far.
I'm just annoyed by people posting that it IS best in class when they clearly do not have the data to make such a conclusion. And now people are asking me to prove otherwise, as if that's the burden of proof.
I guess this reminds me why I don't frequent this board often... you have much more patience than I do
"Harvey told me" is not really an appropriate answer.
Everyone should really be dealing in facts and not exaggerations or hype.
ARQL:
A pig and a dog.
ONXX / Regorafenib:
Most anticlimactic approval ever. Seems the market hasn't even noticed.
ARQL:
Apparently it's a dog and a pig. Hard to discuss when you've already made such conclusions.
All time scams:
I still think Introgen deserves mention.
Those guys had months of CCs where investors were trying to figure if they had or had not actually submitted a BLA.
PPHM:
Never good to see people lose tons of money. But if this plays out as expected, we'll soon be heartened by emerging stories from the longs who sold for large profits late last week.
VVUS:
VVUS:
It's cliche but I never really saw this as the type of drug european regulators would be excited to approve.
THLD:
Someone with better stats skills can correct me, but I'm having trouble visualizing the K-M curves here.
You have a significantly different median value, and it sounds like we're tempering expectations for the right side of the curve due to crossover. So if the HR is 0.95, then it doesn't sound like the K-M curves separated much prior to the median, do they?
Or did they significantly separate prior to the median and then cross-over with the drug group falling beneath the control group?
For me the only negative for MDVN is the drug's name. Sounds like an ED drug.
Exel / mdvn:
I think the exel drug is active, so it would be a tempered bust. The risk in my view is more operational: exel management being slow / careless in extracting maximum value for shareholders. If they do a good job you could see 2-4x current valuation at some point, but you could easily see 0.5 - 0.75x also.
After a few local conversations, I'm rather comfortable that mdvn's drug will sell nicely. Seeing 1.5 - 2x current valuation is, as far as single drug biotechs go, a 'safe' bet ... But no way do we see 0.5x of the current valuation.
Mdvn and exel are a couple of my favourites going forward, albeit with very different risk rewards.
Aria:
It reads as if they reported unconfirmed partial responses. I really dislike that.
Corrections welcome if I've misread the abstract.
ONCY:
Also, why are the met patients not progressing as fast as the local disease patients? Doesn't that invert decades of oncology findings?
ONCY:
Take the 80 patients from both arms, slice them into two groups, then divine meaning out of the numbers to increase enrollment. If I wasn't of such a sunny disposition all the time, I'd think they're just trying to expand the cohort of months that they receive a paycheck.
Also, can anyone make sense of this?
EXEL
PPHM:
It's really not as laden with double standards as you make it out to be. The randomized trial in this case doesn't have that many total patients, so skepticism is indeed warranted.
For an example, here is this little randomized gem from Coley Pharmaceuticals.
Purpose This study assessed the efficacy of the combination of standard taxane plus platinum chemotherapy with the synthetic Toll-like receptor 9–activating oligodeoxynucleotide PF-3512676 in patients with non–small-cell lung cancer (NSCLC).
Patients and Methods Chemotherapy-naive patients with stage IIIB to IV NSCLC were randomly assigned (one to two ratio) to receive four to six cycles of taxane/platinum chemotherapy alone or with 0.2 mg/kg of subcutaneous PF-3512676 on days 8 and 15 of each 3-week cycle. The primary end point was objective response rate (ORR).
Results Baseline demographics were similar between treatment arms, although significantly more patients in the PF-3512676 arm had stage IV disease (85% compared with 62% in the chemotherapy-alone arm). The modified intent-to-treat analysis (n = 111) demonstrated a 38% ORR (confirmed and unconfirmed) in the PF-3512676 arm (n = 74) and 19% in the chemotherapy-alone arm (n = 37) by investigator evaluation. Blinded, independent radiologic review for 90 patients showed a similar trend in confirmed response rate (19% and 11%, respectively). Median survival was 12.3 months in the PF-3512676 arm and 6.8 months in the chemotherapy-alone arm, and 1-year survival was 50% and 33%, respectively. Mild to moderate local injection site reactions and flu-like symptoms were the most common PF-3512676–related adverse events, but grade 3/4 neutropenia, thrombocytopenia, and anemia were all reported more commonly for patients in the PF-3512676 arm.
Conclusion The addition of PF-3512676 to taxane plus platinum chemotherapy for first-line treatment of NSCLC improves objective response and may improve survival. Confirmatory phase III trials are ongoing.
PPHM:
There is a small picture of the KM curves here.
The two bavi arms are superimposable. It seems all the excitement is at the control arm.