Intellipharmaceutics International Inc. (IPCI)

[WeeZuhl]

LOL, Numbers, here's the full quote.


Here's your quote, followed by the non-truncated quote. I suggest you learn the difference between BPCA and PREA.


You:

"The requirements of PREA (Pediatric Research Equity Act) are triggered by a new indication, a new dosage form, a new route of administration, a new dosing regimen, or a new active ingredient. Because the reformulated OxyContin was approved while the older formulation was still marketed (and is not considered a new dosage form), the requirements of PREA were not triggered by NDA 22272."

FDA:

To encourage pediatric drug development, the Food and Drug Administration
Modernization Act of 1997 was signed into law and established incentives for conducting
pediatric studies for drugs for which exclusivity or patent protection exists. In 2002, the
Best Pharmaceuticals for Children Act (BPCA) extended the provisions of FDAMA by
continuing to offer an additional six months of patent exclusivity for drugs being tested for
pediatric use. Later, in 2003, the Pediatric Research Equity Act (PREA) was passed and
imposed certain requirements on the sponsors of new drug applications, i.e. a proposed
timeline and plan for the submission of pediatric studies. The requirements of PREA are
triggered by a new indication, a new dosage form, a new route of administration, a new
dosing regimen, or a new active ingredient. Because the reformulated OxyContin was
approved while the older formulation was still marketed (and is not considered a new
dosage form), the requirements of PREA were not triggered by NDA 22272.

Here's another doozy from you:

I think you already know what "NPP" means. The NPP code means Oxycontin has marketing exclusivity for the New Patient Population, which I think is from ages 11 to 17. That means no other extended-release Oxycodone can market or include labeling for ages 11 to 17. Other extended-release Oxycodone drugs can still be approved and marketed to adults. In the case of Xtampza and Troxyca, the two drugs are for use by adults and untested in pediatric population.

So this exclusivity was granted based on safety data in ages 11-17 and done at the written request from the FDA for Pediatric data and submitted with a request for Pediatric Exclusivity directly within the guidelines set out by the BPCA (not the PREA, lol), BUT DO NOT CALL IT PEDIATRIC EXCLUSIVITY. Oh, and also according to you, it appears to work unlike any other form of FDA exclusivity ever granted to any drug ever. Gotcha. Good luck with that analysis. We shall see...