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Interesting. Good luck to you.
I thought today when it refused to go under .055 it was a clear sign it's going higher.
Why do you think that?
What do you think it will dip to?
When does the CEO talk. Any hard date?
Results were great. Company hinted at spectacular results over the summer.
17 cents target?
2. Discussed status of the company.
What'd they talk about there.
What's the interest in Baltia?
Ok thanks! So target date should be 6 months from acceptance.
Question
Since they're going after the 505 b2 pathway does that mean it's 6 month review. Or do they have to apply for fast track?
I looked and it does fit in my opinion for fast track because of the lowering blood pressure.
Probably get bought out right after nda filed
Yeah but if you put a market order for 7.61 million shares you'd send the price to the moon and If you did a limit order you wouldn't fill it all
I think Nash end of month maybe
I got in warrants just before the news last week. My buddy did the DD for and I verified. Looks solid.
They use the term smoke signal on stock twats for the after hour price jump
Smoke signal again after hours?
I wonder if it's because it's so undervalued. Or a deal is really in the near term
In renal patients
Full clinical study. On kit-302
News this month
Warrants tell the story here
Question.
In the fact sheet H2 2016
Says completion of phase 3 clinical trial full study report.
Was that Tuesday's news or is that still to be expected?
300 million dollar question when?
Oh yeah! I've read your posts and others. NDA should be this year. And potential buyout very likely.
I wonder if Pfizer has talked to Kitov yet.
Stocks just seem To go down after his reports. I'm in warrants. Got lucky and tripled my position Monday.
And today's action is why I hate clay trader.
Good point.
300k to negotiate first I believe.
If they were smart they'd lock it up now
Traded a % of its value roughly. It's accumulating. I think a long run is coming.
No give em a call!
Seems like the FDA just pushes the goal line farther away everytime remoxy is at the line
Understandable but it opens the door for more drugs using the Oradur technology
Durect gets royalties on sales of remoxy. Oradur is the ADF technology used if approved opens many doors for other drugs
Here's a lil more of a tidbit. Makes me understand why adcom was cancelled
PAIN THERAPEUTICS ANNOUNCES POSITIVE TOP-LINE RESULTS FROM HUMAN ABUSE POTENTIAL STUDY WITH REMOXY
REMOXY Meets Both Primary Endpoints with Statistical Significance (p < 0.0001)
AUSTIN, Texas, May 12, 2015 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc., (Nasdaq:PTIE) today announced top-line results of an FDA Category 3 Human Abuse Potential Study with REMOXY Extended-Release Capsules CII, its lead drug candidate that is specifically designed to discourage certain common methods of drug tampering and misuse. This study demonstrated with statistical significance (p < 0.0001) that both intact and chewed REMOXY were less "liked" than immediate-release oxycodone on the two primary endpoints, Drug Liking and Drug High. The Abuse Potential study was conducted in non-dependent, recreational opioid users, as recommended by FDA guidelines.
"We believe today's results demonstrate abuse-deterrent properties of the REMOXY formulation against a common, and often lethal, form of oral drug abuse," said Nadav Friedmann, PhD, MD., Pain Therapeutics' Chief Medical Officer.
Study Design
Pain Therapeutics' former corporate partner for REMOXY had sole responsibility for this FDA Category 3 Human Abuse Potential Study with REMOXY. This study was conducted in accordance with draft FDA Guidance to Industry on Abuse Deterrent Opioids and interactions between the study sponsor and FDA. The study was randomized, double-blind, placebo and active controlled, using a 4-way crossover design in healthy, non-dependent recreational opioid users. Nearly 60 subjects completed this study, with an average age of 27 years. The study's primary objective was to measure the abuse potential of chewed and intact 40mg REMOXY compared to 40mg immediate-release (IR) oxycodone when taken orally. Study subjects were instructed to chew REMOXY capsules vigorously for up to 5 minutes, but none were able to do so in light of REMOXY's high viscosity, texture or taste. Pharmacodynamic measures of the primary endpoints, Drug Liking and Drug High, included use of a standard 0-100 point Visual Analogue Scale (VAS) in the initial two hours post-dose (AUC02h), as recommended by FDA to assess a formulation's abuse potential. The sponsor generated study tables for this Abuse Potential Study in December 2014. Pain Therapeutics has not performed an independent analysis of study results.
Top-line Study Results
Clinical and statistical highlights include:
On the co-primary endpoint of Drug Liking, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0001) compared to IR oxycodone.
On the co-primary endpoint of Drug High, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0001) compared to IR oxycodone.
On the secondary endpoint of Good Drug Effects, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0001) compared to IR oxycodone.
On the secondary endpoint of Bad Drug Effects, scores were significantly higher for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0079) compared to IR oxycodone.
On the secondary endpoint of Pupil Constriction, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0001) compared to IR oxycodone.
On the secondary endpoint of Nausea, scores were significantly lower for intact REMOXY (p < 0.0001) and for chewed REMOXY (p < 0.0143) compared to IR oxycodone.
On the secondary endpoint of Feel Sick, scores were significantly lower for intact REMOXY (p < 0.0002) and for chewed REMOXY (p < 0.039) compared to IR oxycodone.
"We believe results of today's study speak to the clinical and commercial potential of REMOXY," said Remi Barbier, President & CEO of Pain Therapeutics. "REMOXY's high viscosity is intended to deter injection and snorting. We believe this feature, coupled to today's data on oral abuse, contributes to an overall assessment of abuse potential that supports a label-claim for REMOXY."
http://www.biotechnologyevents.com/node/6987
Thanks you too!!
Me too.
You know what ticked me off. I poked around regulations.gov searched remoxy. And In 2011 there was a petition to not approve it by Purdue pharma.
Didn't they approve pfizers drug on a weekend
Seems so
It was news to me. Found it on a Australian clinical website.
They started a psoriasis trial with 928 in Australia
Probably gap up tomorrow