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Amen to that! Say it again!
I like this part:
Great question, doc
Elite Pharmaceuticals Goals, Investor Presentation April 2016
http://ir.elitepharma.com/events_presentations
Lasers try this link:
http://ir.elitepharma.com/events_presentations
My problem with flipping shares.
A long time ago I stopped thinking about my ELTP share count and started thinking in terms of the percentage of the company that I own. I imagine that all the shares are evenly divided so that everyone has my share count, and then I count the number of chairs at the annual shareholder meeting. I'd have to put a tent out in the driveway, but right now we could have the meeting in my garage. If I start flipping shares, that means more people in my garage. I don't like a lot of people in my garage. This all makes sense to me.
Eight months ago, huh? Hmmmmm.
Fun With Pharmacokinetics: OxyContin In Trouble?
Here's a gem from Collegium's Xtampza ER advisory committee material:
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AnestheticAndAnalgesicDrugProductsAdvisoryCommittee/UCM461640.pdf
Look at the dotted orange line which mimics the solid red line. This is Collegium showing the FDA that crushed (read: chewed) OxyContin is just like crushed IMMEDIATE RELEASE generic oxyIR. This is important. FDA says if there is an ADF that does something yours does not, then you could be pulled. Collegium shows their Xtampza is crush-proof while OxyContin dose dumps with physical manipulation.
Pfizer's ALO-2 12 hr oxy is an antagonist ADF and will have flat-line drug liking curve similar to what we see with ELI-200. Elite's 12 hr oxy ELI-201 would likely have similar flat line drug liking. IPCI claims Rexista is months away- I assume it works. How many 12 hour oxy formulas that are TRULY crush-resistant will hit the market before the FDA pulls dose-dumping OxyContin?
By the way, notice how when Xtampza is crushed (blue lines), the oxy is released at the regular rate (controlled over 12 hours), as opposed to OxyContin, which appears to release all the oxy immediately. But when both ALO-2 and ELI-201 are crushed, naltrexone is released. Therefore, ALO-2 and ELI-201 will look much better on the drug liking curve than both OxyContin AND Xtampza (and, really, most if not all the hard shell and gummy ADF's).
Dear WeeZuhl,
Some of our regular readers send questions to WeeZuhl. Here’s a recent arrival to the inbox.
It's not labeled, but...
Nobody is fooled, doc
Like all true and faithful longs, doc loves his SequestOx!
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=112385298
Kempharm fails to acquire ADF label.
Here's why:
Kempharm was applying for a Category II ADF label based on the above PK graphs of KP201. Intranasal KP201 is orange line and hydrocodone is blue line.
https://www.sec.gov/Archives/edgar/data/1434647/000156459015008097/kmph-ex991_6.htm
This is what I think will happen.
2009 called. They want their warrants complaint back.
There have been no new warrants since 2009. All of the warrants were via 2009 Epic Strategic Alliance, which was lifeline funding. It saved the company, but it is one of the negative factors that drove this stock down to single digits and allowed so many of us buy substantial portions of the company. This is excellent DD- just unfortunate you did not come upon it five years sooner. Now the warrants are all gone. Epic distributed the last of theirs in 2015, and most of those went to directors with reporting responsibilities. There are a few million stragglers out there, including some like these that expire next month. Others expire later 2016 and some 2018.
As these stragglers come home to roost, it provides R&D $$ for Elite. And of course, the other thing that is coming home to roost from the 2009 Epic Alliance is 15% $$ of their recently-approved oxycodone ANDA. And we get that just for looking pretty, which we do.
Today's Form 4 by Carter Ward is interesting. I do not recall ever seeing him report warrants. His filings are usually stock & options. Dianne Will told me via telephone last year that she thought Carter was also a member of Epic, but I had never seen any evidence of it until today.
I think the point is pretty clear.
Trying to prevent opioid abuse is like the world’s sorriest game of Whack-A-Mole. When abuse-deterrent OxyContin was introduced, heroin overdoses increased by 26%.
(http://archinte.jamanetwork.com/article.aspx?articleid=2276923).
The ADF’s, including ELTP’s 2 bead pharma-based ADF, will prevent abuse where the pills are crushed for snorting or injection. The majority of abusers will not be affected by these ADF’s because they swallow whole pills, but the hardcore IV users will move on to something else. Maybe to heroin, more likely black-market fentanyl these days.
https://www.bostonglobe.com/metro/2016/05/02/fentanyl-involved-more-than-half-overdose-deaths-state-reports/ALpo8q8VRHxa27Tzm6YYvL/story.html
REPOST: My favorite R&R slide.
Shows Mean Drug Liking on Visiual Analog Scale (VAS). Time is on horizontal axis. On the verticle axis, anything above 50 means they liked it, below 50 they disliked it. Notice the expected liking of snorted oxyIR (green). ELI-200 (blue) is actually *disliked* at the outset- see how the blue line falls below the placebos (red & yellow). For some reason, drug abusers disliked snorting it, as opposed to feeling neutral, like snorting the placebo. And ELI-200 never bumps above the placebo line, indicating the naltrexone effect is long-lasting. (I'm looking at you, alleged-ADF Targiniq, with your short half-life naloxone instead of longer half-life naltrexone.) A great data slide. Thanks Nasrat!
Solve addiction?
Exactly right.
Great Question
ELI-201 Reference Drug Moving Forward
Pfizer is moving forward with pediatric studies for ALO-2. This will allow for additional market exclusivity upon completion. They have a similar study for Embeda, which has been an ongoing trial since 2014. This ALO-2 study was added in January and updated in the past 2 weeks to show recruitment.
This is important for ELI-201, since Nasrat has indicated that he may use the 505b2 NDA pathway with Pfizer's ALO-2 oxy/naltrexone 12 hour drug as a reference. We need ALO-2 approval before that can happen. Some have suggested that FDA's delay in approval for ALO-2 spells trouble, and maybe so. But we're rooting strongly for Pfizer on this, not just because ALO-2 is 505b2-bait but also because Pfizer's marketing department is our bestest friend forever in the category of pharmacological-based ADF's.
I strongly doubt Pfizer would be moving forward with these ALO-2 studies at this time if they were not 100% confident in ALO-2.
Go Pfizer! (Ugh. I feel dirty now.)
You make an important point here, namtae
Misinformation.
Correct info here:
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=122229297
DD is hard.
DD is hard.
Your mistake here is to confuse the 2013 Epic Agreement on generic drugs with the 2015 Epic Agreement on ELI-200. The $403,999 is cash received for the 2013 generic drugs, whereas the $5,000,000 ELI-200 milestone payment is on the very next line down of the original 10Q. If one is really interested in proper DD on this subject, one could refer to the discussion in the same 10Q of the "Milestone Method" of accounting for this $5,000,000 payment, which was subsequently re-stated following comment from SEC to realize the $5,000,000 over the entire term of the agreement. You can find the links for yourself, but the most relevant passage for those interested in accurate information on the ELI-200 milestone can be found here:
http://www.edgarexplorer.com/EFX_dll/EdgarPro.dll?FetchFilingConvPDF1?SessionID=HTWEe33gpUeB8-9&ID=11159374
I’ve been in the mud with this pig for a long time now, and let me tell you, she stinks pretty good these days compared to when I went head-deep in the slop. But now that my smelly pig is four times the size she used to be, I’ve got all sorts of folks lined up to tell me how much my pig stinks.
I love the way my fat pig stinks. If she didn’t smell so bad, I never could have afforded her. I figure she’ll be ready for slaughter ~2018, until then you’ll have to find your own smelly pig because I’m not selling mine.
Long & Strong ELTP,
W.
Final Phase II Results: AE37 improves disease-free survival in triple-negative breast cancer.
http://www.ncbi.nlm.nih.gov/pubmed/27029708
Ann Oncol. 2016 Mar 30. pii: mdw150. [Epub ahead of print]
Primary Analysis of a Prospective, Randomized, Single-Blinded Phase II Trial Evaluating the HER2 Peptide AE37 Vaccine in Breast Cancer Patients to Prevent Recurrence.
Mittendorf EA1, Ardavanis A2, Symanowski J3, Murray JL4, Shumway NM5, Litton JK4, Hale DF6, Perez SA2, Anastasopoulou EA2, Pistamaltzian NF2, Ponniah S7, Baxevanis CN2, von Hofe E8, Papamichail M2, Peoples GE9.