Intellipharmaceutics Intl. Inc. (IPCIF)

[WeeZuhl]

Weezuhl- Will you be attending the Intelli Adcom next week?

https://ih.advfn.com/stock-market/USOTC/intellipharmaceutics-IPCIF/stock-news/81481183/prospectus-filed-pursuant-to-rule-424b3-424b3

In February 2018, the Company met with the FDA to discuss the above-referenced CRL for Oxycodone ER, including issues related to the blue dye in the product candidate. Based on those discussions, the product candidate will no longer include the blue dye.

Mission accomplished. No need for me to attend this AdCom. I don't think this drug brings much that is new to the table to either prevent abuse or attract prescribers, but without the untested, poisonous blue dye in the formula, I no longer believe it represents a severe safety risk to unsuspecting consumers.


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If I were Intelli, I would have Dr. Odidi wave and smile from his seat while keeping his mouth shut. Whoever presents for the company, every answer to every question should be some version of either, "No food effect, unlike Xtampza" -or- "No dose-dumping with alcohol, unlike OxyContin." Those are the only two benefits of this drug over what is already available, and FDA has repeatedly said it will not approve any new opioid that is not as good as or better than what is currently available. Since Xtampza has the chewing abuse deterrent label, if FDA approves this drug without the chewing label, then they would be going against their own guidance. It will all come down to the chewing and snorting HAL studies. We should get a sneak peek at the data on Monday, as well as FDA's attitude about this meeting. In my experience, these meetings go the way the FDA wants them to go, and this is often apparent in the advance documents.


Pay close attention to the advance documents, and act accordingly. GLTA.




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April 13, 2017:

But what I take exception to is the repeated posts about how Rexista is based on some unique ADF technology that is patented and proprietary. It very simply IS NOT. It is not patented, and it is not unique, other than the poisonous blue dye, which we all know will never make it into the final formulation that gets approval. Take the blue dye out of Rexista, and what you're left with is very expensive generic OxyContin that can be chewed "like bubblegum."

Rexista might be the best to chew while in class, but it will never be "Best In Class."