Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
You're right, it is different.
Rexista’s Blue Dye Will Never Get Past AdComm
No Advantage + Possible Side Effects --> Hindenburg
http://www.fiercebiotech.com/biotech/19-1-vote-fda-panel-rejects-acurox
PTIE's Remoxy CRL was all about ADF label.
Man, those guys really know how to PR a CRL. Practice makes perfect. As I previously predicted, no new NDA approval without ADF label. More important, it turns out Pfizer was correct to give back Remoxy to Pain & Durect in order to focus on Embeda and ALO-2. Pfizer knows that the antagonist ADF technology just plain works better. ELTP 2 bead antagonist ADF is best yet. Unlike Pfizer's anatagonist ADF, ELTP 2 bead ADF is modular across the entire spectrum of opioid agonists and time-release characteristics.
https://globenewswire.com/news-release/2016/09/26/874482/0/en/Complete-Response-Letter-for-REMOXY.html
It'll take less time than that...
Exactly.
The message is starting to sink in.
Objective observers are not having a problem.
More like BAIL OUT negotiations...
An easy experiment.
I don't recommend this with any of the meds you listed because most are either stimulants or sedatives, but it would be okay to do this with Aleve, which is a light blue caplet. According to its product info sheet, it uses a form of Blue #2 called blue #2 lake, which is one of hundreds of FDA certified varieties of Blue #2. Now take that Aleve caplet and chew it up until it is all dissolved in your mouth. Now go look at yourself in the mirror. Have your lips, gums, and teeth turned to an intense blue color? Of course not, because Aleve uses blue #2 as a general use color additive. To the contrary, Rexista uses Blue #1 or Blue #2 as an ACTIVE INGREDIENT, which will require a much higher dose of blue dye, two times per day, every day, forever. And with zero benefit to the legitimate user. The truth is clear to everyone who is not in DENIAL. Rexista is a ticking time bomb AND an ethical nightmare.
http://labeling.bayercare.com/omr/online/aleve-caplets.pdf
You require remediation on food dyes.
The facts are clear.
100% Complete Confidence
Endo wouldn't touch Rexista with a ten-foot pole.
ELI-201 Competitor Rexista May Have Blue Dye Problem
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=125369441
Oh, I've seen it. BIG problems here.
Want to be part of human experiments?
Ask your doctor to change your oxycodone prescription to Rexista so we can learn for the first time about the effects on human beings of long-term twice-daily exposure to concentrated blue dye. If this were a true controlled study, you would have to sign a special ethics statement that you were aware that the concentrated blue dye could not possibly provide you with any benefit whatsoever.
https://cspinet.org/new/pdf/food-dyes-rainbow-of-risks.pdf
Rexista's Blue Dye Problem
Rexista users could turn blue and die.
I have no interest in a discussion.
You should post one. Everyone can play.
You are quoting another poster from this board.
Absolutely incorrect, already answered by the company.
FALSE: "PODRAS is already part of the formula in Rexista."
Not only is PODRAS not currently in the formula, it's not even currently a real thing. It's an idea which has been patented. The extensive clinical trial & error to get it to work will take multiple years and more likely than not will never work. Functional or not, it'll cost $25-50 million, maybe more, to figure out. Acura is working on very similar concept. They're multiple years ahead of IPCI, they have funding, and they have an actual research staff-- none of which IPCI currently has. Here's what Bob Jones said in a recent conference call about how much progress they've made in TWO YEARS:
Simple facts, basic speculation.
First they say Q2 then Q3 then Q4. The waiver was because it is the first NDA from a small cap pharma- has zero to do with the merits of Rexista. Likewise, the company merely reported the food effect study, not any commentary from FDA. When the company repeatedly misses their own deadlines, then it welcomes speculation as to why. My speculation is just as valid as any others, and in the eyes of an objective observer, more valuable than the offerings of someone who only sees sunshine and roses.
Speaking of LOL, NDA application for nPODDDs is delayed because they're waiting for patent approval for PODRAS. Hilarious.
Robert Califf's FDA putting the brakes on Rexista?
More than one opioid company has gotten unexpected bad news since Cahill took over the FDA. Last we heard of an FDA opinion on Rexista was in May 2015, when IPCI reported the FDA letter that said no Phase 3 was required. Califf took over FDA a year later, in April 2016, after a significant public scolding from the U.S. Senate regarding the FDA's opioid approval process -AND- the FDA's cozy relationship with drug companies.
There have been many changes at the FDA since IPCI released any public info regarding current FDA guidance on Rexista. The company has now missed multiple self-imposed deadlines for Rexista NDA filing. While there are many possible explanations for this, one significant possibility is that the company does not feel confident with the application based on their most recent discussions with Robert Califf's "New" FDA.
https://www.ket.org/opioids/dr-robert-califf-on-the-fdas-action-plan-for-drug-addiction/
You didn't miss a thing.
Great stuff, N2K. Thanks.
You're almost there...
I know all about ticks.
JL what does this mean?
Treppel converted his Preferred already.
Why convert the Preferred?