Irrespective of the results, PFS was a puzzling endpoint anyway (part of the botched trial design). It has very bad correlation to "clinical benefit" which are the magic FDA words for gaining approval. In other words, you can have stat sig PFS results with NO clinical benefit and this fact pattern happens quite frequently. This will result in a rejection 100% of the time. The primary benefit PFS imparts in a clinical trial setting is that you get a quicker trip to unblinding since OS may take years (although not in this patient population). That advantage has been squandered in this trial by the long delay engendered by the "surprising" results, making the PFS data essentially useless. Moreover, inquisitive minds might reasonably inquire why ONCY chose PFS as an endpoint in the first place, since, in this particular clinical setting where patients have a median life expectancy of 4.9 months, you will have OS data at almost the same time as you have PFS. (I have my own suspicions why they chose PFS). So before you money shot in your drawers if the PFS data is favorable, remember you are not much closer to FDA approval until OS results are announced and/or some other unknown clinical benefit like QOL is established. .
Although I rarely short if the PFS data is marginally favorable I will be shorting the bounce for a short term guaranteed profit, as the tyros rejoice over relatively meaningless data. I would hope to be long gone by the time OS results are announced. That will be a big day one way or the other.
While others have responded with contrary evidence and a vitriol like that you have addressed them with I would offer a bootless counter. You say PFS has a poor correlation with "clinical benefit". That may be true but its raison d'etre in our trial design was its strong correlation to median OS in this indication. And OS is still the gold ring.
The rationales you offer seem wholly consistent with a shortseller's view of the market. Do you routinely short biotechs? And are you short ONC?
I have never shorted a biotech and thoroughly looked at ONCY as a potential long before rejecting it. Nevertheless, I have gone on record as saying I will short ONCY within a few days of the release of "favorable" PFS unless the in my own opinion, the results are overwhelmingly positive. I note that the 6 week results were not overwhelmingly positive. They were statistically insignificant in the non mets population ("numerical trend" is a euphemism for not stat sig.) and were 2 patients either way from being not statistically significant in the mets arm.
Posting is part of my research. I wanted to see if anyone had insight or made a better long argument. No insight no compelling long argument, and I wanted to see how pollyannish the buyers at the margin are. Based on this small sample, I think that there are a lot of very, shall we say, unrealistic expectations and ignorance of the trial, the FDA approval process and prior results out there. Thus if the news is favorable I think the stock will overreact in the short term. As you say OS is the gold ring and the primary endpoint of the trial. And you will have your answer on that pretty soon.
And as I've pointed out before, one of the reasons PFS often doesn't correlate well with OS is because the agent that is controlling tumor size is also tremendously weakening the patient. Reosylin isn't doing the kind of damage that most do.
To be clear kind sir. NDA's have been submitted based on a Piii trial using PFS as a primary endpoint and I never said they haven't. Your reading skills are flawed and BTW so are your reasoning skills. -- NO compound or biologic has ever received approval based on PFS. They received it by proving "clinical benefit" and PFS is not synonymous with clinical benefit. This seems to be a very hard concept for you (and prolly others) to grasp. Apparently you do not know the most basic tenets of the FDA approval process. Lots of powerful stooopid on this board. (But stoopid can make money too, just not consistently)
"How can you not know that we have FDA approved blockbuster cancer drugs with approvals based on PFS primary end points?"
Hgff your above response to Rational is spot on:
From the article "Cancer Care in the U.S. – Looking Back, Looking Forward" by Richard Pazdur, M.D., who is the Director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research.
"To expedite drug development and our review of applications, FDA has approved oncology drugs on the basis of a single trial and used a variety of clinical trial endpoints — including overall survival (the time a patient lives before death), progression-free survival (the time a patient lives without their cancer progressing), and response rates (tumor size reduction). FDA has taken advantage of regulatory initiatives for serious and life-threatening diseases, such as fast-track, priority review, and accelerated approval."
If you search on the article name you'll find the complete article - from January 2012.
Also PFS as a clinical end point has been talked about previously on these boards and the FDA is becoming more and more amenable to it even if it doesn't add to OS because it has the benefit of delaying symptoms and giving patients a better quality of the life for the time they have left.
IMO Reo will extend both PFS and OS.
"I would hope to be long gone by the time OS results are announced. That will be a big day one way or the other."
Your last sentence is EXTREMELY accurate. Yes, the day you are long gone WILL be a big day!! Please make it soon!
Go ahead and short ONCY; mortgage your outhouse to do it! Your posting has been consistently inaccurate, devious, and disingenous; in short, you have !@#$ for brains. Now go comfort your roomy hasbeen; I am sure he misses you.
Sentiment: Strong Buy