Ramwrk may be under the impression that REO 018 is a registration trial.
He may not know that a new phase III registration trial must be negotiated with the FDA, enrolled and conducted before Oncy can potentially file for approval.
What do you haveto say to him?
Ray85, I was expecting phil to reply to your posts about military and government in Facism by spewing TP ludocrities such as FEMA Death camps and Czars and such.
Phreep you have no idea how decent BT has been to Oncy longs
First, this spring and summer, he gave us every tacit inidication that things were not going gang busters.
Thats when I gout out.
Then, he gave you a nice spin yesterday, snatching a 25 precent drop from the jaws of an 82 percent drop.
Id venture to say if Oncy was run by a typical biotech penny CEO it would be trading at 20 cents right now.
Nome, right now I'm just relieved that I did t buy into the Reo story and end up long yesterday.
My price for Oncy would be a fully diluted market cap of 50 million, meaning a share price of 62 cents.
BTW, we wont know if there will be a Phase III H and N trial until Oncy gets approval for a phase III trial, which will take months to up to a year.
Be careful with Nome, while his posts are correct, many longs here have found comfort in them and remained long into these bad results. This is why he is the Most Dangerous person on this board.
For instance when he writes "What you didn't address in your post is the fact that REO is quite active. The control PFS was 50 days as predicted by historical norms. But the PFS for REO was minimally 94 days. I say minimally because the best responders were probably taken off the REO arm disproportionally based on viral symptoms. "
It is up to you to recognise that there is an expanding graveyard of drug and biologic candidates that are "quite active", but not active enough to gain FDA approval.
It is up to youto recognize that no PFS or. OS P values were given. P values are what the FDA Uses 99times out of 100 to determine if a candidateis approvable.
Longs who are emotionally invested in this will make excuses for the lack of all important P values.
Ive been watching Oncy for some time and came to the conclusion that Reo is active, but the hurdle for being active enough appears too high.
In order to give Reo every chnace at success, CEO put best face on ambiguous numbers. That's his job.
Nothing wrong with that, but its certainly no reason to go long.
No PFS or OS P values given?
Fox, the answer to your question is: they unblinded yesterday and dumped the lipsticked data today BEFORE discussing it with the FDA.
If you can't read through font 20 lines, just stay long, as you dont seem particularly bother dropping six figures here or there.
Now remember this, Oncy has a duty to present its baby in the best possible light, so the press release is spun positive. BUT THEY DID NOT EVEN TAKE IT TO THE FDA before putting it out.
How blind can you be? Its over.
-"Furthermore, should ONCY license Reolysin in the UK / EU on the strength of these Phase III REO18 clinical trial results, one can project a significant revenue stream developing quickly."-
Someone put this guy in conservatorship!!!!
-"ONCY has plenty of cash to conduct a registration study in the United States"-
I nominate Baghdad Bailey as the new board authority to replace nome immediately!!!!
Tred, one other thing, what gives you any firm confidence that mess of "data" will even meet the FDA's hurdle to justify a phase III trial?
Can you even be sure firms will step up to support a capital raise at this point?
Tred, I'm less interested in being perceieved as worse or better than someone long Oncy as I am in learning to differentiate promising devepmental bio, phrama companies from obvious loosers.
I find it astounding that intelIigent people could consider this an investable company at this point.
A virus that kills cancer and leaves healthy tissue alone: Its a great story, but it 10 years of studies ismpointing to the conclusion that it doesn't kill enough cancer cells.
How can you not see this is on a direct vector to 75 million market cap?
There yougo, yu heard it from bailey! Oncy will next announce applications for approval in The EU and UK! The only reason Oncy didt mention it in today's cc? "Everything has its place"!
Keep going bailey! Keep going!
Yeah, Oncy knows their UK and EU options! Thats why they covered them at length in the cc!
Keep em coming Bailey!
Also, why did they get treatet when it wast in the protocol? I thinki ts because the study basically diintegrated
Is it just coincidence the boris and natasha messages came out just a day or two ago? They were a warning signal from someone who knew.
This trial just gets curiouser and curiouser.