Very excited about dur-928. another condition to be indicated that they're not ready to discuss. Bio markers if move will send us in the spot light with just a single dose.
Posimir it is my feeling they want to partner this soon. So the partner gets to have a great marketing advantage. Remoxy pain wants to partner. Data against Purdue next week. My assumption is with a growing field in 505-b2 drugs this will call for OxyContin to come off the market.
Sentiment: Strong Buy
Posimir the market reacted to the news. Seems it determined it was a minor setback. NDA is a slam dunk on Remoxy. DUR-928 speculation could send this up 5-10 fold down the road. Should get positive news on single dose in Nash patients. Wild card ZGNX partnering Relday, I think we'll get Orient Pharma data on ADHD phase 3 trial in September. long strong
Side note: ELTP=trash
Sentiment: Strong Buy
In the last call they said money is not an issue for the phase 3. We'll get more clarity at the end of the month. There should be a dur-928 trial starting soon and data from the Nash single dose this quarter. It's for safety but if it show efficacy it's a home run one (not expecting it to be). Also the PDUFA for Remoxy will be announced this month according to pain.
That's why you're posting on another board right?
The they won't even put out revenue projections. The FDA let them waive the NDA fee of 2 million. If it was going to pass they would of charged them. Insider sold. Stocks down. Otc pump dump.
Why are you posting about another company on this board?
What's up with douchebags touting their own stock on a different stock's board.
Yeah I'm going drop my investment to get in yours off your pumping attempt.
This board is for DRRX.
I wonder why an insider sold 190k dollars worth after that news? Why not hold it after approval?
That eltp drug is not going to get approved. They're a pump dump stock.
on the pr for that the stock went up 4%. No ones confident in eltp
Pfizer created their own abuse deterrent. The FDA gave them what they had to do, pain therapeutics confirmed with the FDA.
As of July 23, Pain Therapeutics provided an update on REMOXY and I would like to repeat a few of the things that they said. First, they're focused on the NDA resubmission and have substantially completed the transition of REMOXY from their formal partner.
Second, they've received - recently assessed the long-term stability of REMOXY and found that stability testing at 12 months was within the specifications. Third, they earlier had announced positive topline results from a human abuse potential study with REMOXY. This study demonstrated with statistical significance that both intact and chewed REMOXY "were less liked" that's in quotes, than immediate release oxycodone on the two primary endpoints and those endpoints were drug liking and drug high as determined by non-dependent recreational users.
Fourth, Pain Therapeutics stated that their previous partner had reached a written agreement with the FDA on the specific content of an accessible NDA resubmission and that Pain Therapeutics had recently received written confirmation from the FDA that this key regulatory document remains valid and applies to their NDA resubmission.
Lastly, they reiterated an expectation of resubmitting the NDA in the first quarter of 2016. After resubmission there will be a six month FDA review and as such we look forward to the potential approval of REMOXY in 2016.
Although there are number of products and development, to-date no new control release abuse to turn oxycodone product has been approved, and the current estimate for resubmission would mean that REMOXY would be eligible for approval in the third quarter of 2016, so potentially a year from now we can have our first product on the market.
Is anyone out there?
The posts about stock picking websites are annoying.
Remoxy NDA is due any day next week. I'm sure many investors have written it off but I still believe it will get across the goal line in 2016. I read the transcript from an earnings CC over the summer they said Pain has worked out all the issues with the drug.
Does anyone know what's going on with Impax they've had the drug Eladur for 2 years now. Zogenix is waiting to partner relday.
928 there will be data out on it next quarter, will this be data that starts to move us up?
As for the share price. It's really cheap considering Remoxy could be on market next year. Posimir may partner anytime but they want the best deal because it's a better drug than what's out now.
We should have more clarity on 928 in the next few months.
Sentiment: Strong Buy