Clearly a new tactic being instigated by the remaining short-disturbers. Trying to create confusion by stating the H&N is not Phase III. Ridiculous, and this suggests to me a new sense of panic among this group. As for herex, just click on his name and look at his posts over the past while. His previous tactic was to suggest Rat had insider info.
Nov 8th unblinding with Christmas present finalized results.. Then it comes down to how big of a trial and who pays for it? Hopefully we can be quick to market elsewhere in the meantime..
Sentiment: Strong Buy
I'm not sure what the argument is here, but it sounds like some of you better listen to herex in this case. If you believe the pending results from the Phase III head and neck trial are the "pivotal results", then you haven't been paying attention. Read the press releases and listen to the conferences - the original design was a "two stage" trial, with the 1st stage having a targeted enrollment of 80 patients - based on the OS results from this trial, they would then they originally disclosed they would enroll another 100-400 patients (195 being the most probable per the 5/25/10 press release) that would target the patient population expected to generate the pivotal results. In late 2012, they did a partial unblinding of the 80 patients and decided that they would expand that "1st stage" enrollment to 160 patients in order to better understand the response differences seen between patients with metastatic disease vs those with local disease.
The company's current disclosures indicate that the OS data from these 1st stage patients (167 actual enrollment) would be a "supportive study to a planned registration trial that will be similar to, and take the place of, the original second stage" of the Phase III trial (Sep 12 press release). Is there a possibility that the OS data from this 1st stage is so overwhelmingly positive that they decide to file an NDA based on the 1st stage only - possible, but very unlikely.
To be clear here, I am long ONCY - if the pending data are positive, I think it SHOULD drive the price higher, because it is the first randomized/controlled data they will have. But like a lot of their press releases lately, I think there is a risk of market confusion here - i.e. " these results are great and have given us the data we need to design a successful registration trial, which will take another three years" - do you think that message will drive the price higher? If the "market" is expecting pivotal results and an NDA, then who knows?
I'm not sure what the argument is here, but it sounds like some of you better listen to herex in this case. If you believe the pending results from the Phase III head and neck trial are the "pivotal results", then you haven't been paying attention.
Tredleon, given that Oncy can put out a very positive spin, I would expect that if either test arm of the stage I head and neck hits .2 or better, you can expect a press release that should cause some kind of spike.
The key to look for in my opinion will be do they not give the OS p value? If they dont give it, it means its not statsig but better than .2. It is possible that even if its worse than .2 they might put out a release that makes it seem the stage 2 will go on...it will be hard to tell, as always with a biotech oress release.
If I were long I would watch carefully for some kind of topping signals on that spilke and then get out.
It will be 5 years from positive result of stage 1 to the first detailed p value if indeed they dont give a p value in the stage 1 release.
As far as I can tell you and falco are the only two non-insane longs here.
Be careful with nome, he will spin you like a top till you catch on to him.
Tredleon: You sound sincere, however, you did post several mistakes. First you state that they did a partial unblinding in late 2012 and decided to expand to 167 patients - this is not true. They did not partially unblind anything until well after 167 had been enrolled and then they looked at 6 week shrinkage only and for the purpose of demonstrating potential neo adjuvant use. This information was released in December 2012.
Second, you state that it is very unlikely that the first stage would sufficient to apply to the FDA for approval. The FDA has been very clear about this... stating that positive results in metastatic cancer would "most certainly" qualify for Breakthrough Technology designation. So there is more reason for optimism then you state. The Breakthrough Designation was announced by the FDA well after the Phase III H&N began enrollment but will likely have a significant bearing on the path forward for H&N as well as ovarian and pancreatic studies. Smile; this is a rather important consideration for your investment in ONCY!
Third; enrollment in a confirmation Phase III trial would not take years. With all the previous work done establishing and training sites all over the world will lead to very rapid enrollment if the results of the first Phase III are positive; enrollment of 200 to 400 patients could likely be accomplished in less than one year as evidenced by the rapid enrollment of the last 87 patients.
Fourth; nobody should ever listen to Herky Jerky or the Rat. Both have a well established histories of negative spin and out right dishonesty. At minimum; they both lie at least once every single damn day. They are both deeply disturbed and disturbing people that likely hang out near elementary schools and playgrounds.
Good luck with your investment and be cautious but don't listen to known liars.
GO HABS GO,
Sentiment: Strong Buy
"I'm not sure what the argument is here, but.."
Oh wow, for all of you who were going to pick a name and number at random out of the phone book, here is free investment advise from a stranger.
You are so full of s#!t, you don't even know how to back up herpie's drivel.
" if the pending data are positive, I think it SHOULD drive the price higher, because it is the first randomized/controlled data they will have"
What will drive the price up is demand. Not so much retail(which is herpie's target here) but institutional demand. And Pharma's demand for pipe line expansion. Positive data will set fire to those two. Mister Market is the Big Guys in this case. If REO performs as expected IN ANY indication, the sky is the limit. All on off-label use.
Herpie hasn't said anything that is not on any stocks IF page. As a matter of fact he hasn't said anything that is even remotely of significance. If you have an average intelligence you can weigh risk/reward yourself and not depend on the likes of Rat/Herpie who embrace an agenda they get paid to push. Do you have to read about the risk of going over a railroad crossing when the lights are flashing, just before you cross? What an idiot!!
Sentiment: Strong Buy
" If you believe the pending results from the Phase III head and neck trial are the pivotal results""
The impending Phase III results have been described by ONCY as the first stage of a two stage process.
This notwithstanding, statistical significance in this "first stage" will not only lead ONCY into a "second stage" clinical trial, but could be potentially introduced as the 1st of 2 statistically significant clinical trials required by the FDA for marketing approval of the drug in the United States. The same 2 clinical trial requirement is not required in the EU before approval is granted - where only one statistically significant clinical trial is needed for a drug to be marketed.
The trial was set up in two stages, stage 1 (non phase 3), and stage 2. Stage 2 was to be a phase 3 trial statistically linked to the stage trial.
Last year, the stage 1 trial was restructured, breaking the statistical link to what woud have been the stage 2 phase III trial.
People on this messageboard who try to tell you the expected readout for the stage 1 trial are phase three results are lying or mistaken.
Its just that simple.
If the readout is good, it will lead to a stage 3 trial.
Nome is the person who is considered to know the most here. Take note that he has conspicuously not corrected the misinformation.
For those simpleton's who have difficultly understanding ONCY's Phase III clinical trial status - Read the PR:
"In September 2012, Oncolytics provided and update on its Phase III trial of REOLYSIN® in combination with carboplatin and paclitaxel for the treatment of head and neck cancers (REO 018). The company had conducted an internal analysis of the blinded combined clinical data for all 80 patients enrolled in the first stage of the study. The study has continued to remain blinded.
The Company had consulted with its principal investigators, the independent statistician for the study and, on September 10, 2012, met with the U.S. Food and Drug Administration in Washington, D.C. Based on these discussions, the Company expanded enrollment in the first stage to include 160 patients, all of whom have now been enrolled. "