Replies to post #23248 on Intellipharmaceutics International Inc. (IPCI)

[fabius]

Numbers your DD is invaluable.

Thanks sooooo much !!

[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...

[doogdilinger]

Don't even waste your time with him numbers...funny how we were told for months that IPCI's Rexista NDA would never be filed because IPCI supposedly knew that their blue dye would turn users blue and kill them!!!

Then when IPCI filed their Rexista NDA directly on the heels of receiving their USPTO PODRAS Patent Approval we were told that there was no way in Hades that the FDA would ever accept IPCI's Rexista NDA...only for the FDA Acceptance to hit last week hahaha!!!

It's going to be a colossal 2017 for IPCI shareholders and there's gonna be lots of crying from the coulda should woulda crowd who passed up on this golden opportunity!!!

5 years from now when many of us are enjoying life changing returns the past few years will be looked back upon with a great deal of triumph for those of us who did our own due and had faith in our convictions to see this story through choo-choo:)