Cempra, Inc. Message Board

PFE will not be worried one bit. Remember FDA granted priority review for this new NCE. There is zero chance Purdue can claim generic Oxycontin. The biggest uncertainty now is if Pfe is going to resubmit...my money is betting yes!

Sentiment: Strong Buy

Given the limited disclosures and ptie downsizing, this set for likely buyout first, then refiling. This scenario would limit PFE expense...

as about as much as your post.....NOTHING!

They would have zero merit!!!

link or source please? Although this outcome would be my educated guess, it's good to deal with facts...

The same hurdles that PFE/PTIE are facing on getting a branded formulation on the market, will be the same hurdles any generic co will have to tackle to get a generic OxyContin onto the market. Extremely high financial barrier due to necessary bio studies....

Pure hogwash again by fg.....as any new branded (IP is important here) will need to under go the rigor of regulatory approval. Generics will also need to meet a similar high regulatory hurdle (bio-wavers will not be a feasible path once so heavily relied on by generics). Perfect scenarios for PFE and PTie,

not based on future royalties and current market caps. PTIE is the place to be....

I have never seen such baseless conjecture with zero understanding of the technology, FDA, and market. The facts are Remoxy and the composition and excipients that make up Remoxy are branded and protected with IP. Remoxy has been tested in large phase 3 trials and has demonstrated abuse deterrence. Making modifications of Remoxy or as fg calls "sticky" simply will not fly due to patent barrier. Remoxy is 100% Oxy in terms of active substance and performance, but not formulation.....this is non-refutable! This will be a direct competitor to Purdue' Oxy, only better due to formulation. As stated, the FDA has raised the bar in allowing generics to enter the pain game as they will now need to show comparability in many capacities including expensive clinical trials.

I wouldn't say he's right, as he is clearly shooting from the hip and faint recollections from CMC technical issues about Remoxy. The CMC technical issues have been fixed as I suspect this to be the most logical conclusion from a productive FDA meeting. The active substance is Oxy, and the formulation is the key to IP and FDA exclusivity. As far as Generic's goes for this indication, the FDA has mitigated any potential threats. Those are the facts! Clearly fg and c..whatever, have their own agendas for trying to murk the facts.

Good luck trying to get Oxy out of grain alcohol and separated, very difficult and no easy task... Microwave will destroy Oxy due to heat and moisture.....

I suggest you check all your facts about whats patented before spewing garbage. Does any one on this board actually think PFE would spend $50-80M (low estimate) that they spent on additional trials, cmc, resources for such a weak patent for Remoxy.....If so, I have a bridge to sell.

any idiot knows that any prodrug technology will not work....JEEZ! Carrier wave is just a BS name for it....

I do know that you have diarrhea of the mouth by throwing around your perceived facts in your dream world. Product managers will have to justify their budgets based on vetted future cash flows for any product due to internal competition for resources. Clearly Exubera's risked adjusted NPV failed the test! Yes any alcohol with large amounts can solubilize over time, however one is left with a mesh of exicipients and Oxy (heavily diluted) and nearly 100% alcohol.....separation of these is no easy task, and drinking this mixture would not be viable. Microwaving would not be discrimating as all subustances would coagulate and breakdown. Separation of Oxy would be nearly impossible if you are not a trained chemists with the equipment and resources. You simply don't understand what you say.......

they are worthless because you say they are...that's hilarious. One should think of IP (issued patents) as barriers to entry just as FDA gives exclusivitiy under HW. Of course there will be attempted patent busters but there is a long road in litigation especially with PFE. Again, PFE has calculated their risks and poured 50-80M (at a minimum)! You will LOSE you #$%$ in PTIE, rest assured....