Replies to post #38599 on Intellipharmaceutics International Inc. (IPCI)

[wimuskyfisherman]

Numbers and Weezuhl- I would love to see Intelli gain an approval for their Oxy ER(Rexista). However, I am a realist... In my opinion, the only way they get approval is with stellar oral HAP results. But based on Odidi's track record of poor applications, CRLs, etc., etc. I would say they have less than a 5% chance of approval and more than a 95% chance of denial. But like I said, it will be based on the oral results... Which they have not published... So place your bets... This is a long shot... But in the event they do get approval, this will run hard. But the odds are more than 20 to 1 against.

[numbersarefun]

WeeZuhl, Oxycodone ER is generic chemical name. An 505(b)2 NDA can be marketed as generic, in addition to name brand, if the FDA gives it a TE Code of AB. Since company is just calling the drug "Oxycodone ER", I assume that is the path IPCIF is seeking. If you look up an NDA there is a column for "TE Code" and Therapeutic Equivalents for NDA are listed at the bottom.

Camargo says there are AB Rated 505(b)(2) NDAs:
https://camargopharma.com/resources/blog/ab-rated-505b2s

WeeZuhl wrote: "As a result, their drug will need to prove abuse deterrence as good as all other NDA's, which means it will need a successful chewing study."

I assume FDA gives guidance on what abuse studies were required after the 1st AdCom. Did FDA say they needed a "successful chewing study" to get approved?

WeeZuhl wrote: "There most definitely will be an AdCom in order to discuss the nasal and chewing HAL studies, which were notably absent at AdCom #1."

I was just guessing no Advisory Committee meeting, since I have not heard of one scheduled yet. Does not FDA need to give company time to prepare for an Adcom and time for FDA to consider Adcom advice? IPCIF's 1st AdCom was announced about a month before the meeting and was scheduled about 2 months before PDUFA. It is getting too late to 2nd PDUFA date to schedule an AdCom.

[doogdilinger]

At this point nothing IPCI informs the market can be relied upon as accurate because time has more than exposed Dr. Odidiot's ineptitude when it comes to dealing with the FDA.

And if there was a chance at success on IPCI's upcoming scheduled Aug 28th Oxycontin ER PDUFA date, one would think that the CAT 2 & 3 studies wouldn't have been kept hidden from the market.

So IMO only, the chances of IPCI's Oxycontin ER going the way Remoxy's gone over these past 10 years is a far more likely outcome than any magical surprise FDA approval at the end of August, as time has totally exposed Dr. Odidiot's ineptitude where/when it comes to advancing anything in this company's pipeline in an even remotely relevant fashion lol...and if it can go wrong, or be done incorrectly, we can be rest assured that that will be the most likely outcome here:)