Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Unrelated issues, and incorrect.

Sorry but you have missed the entire issue regarding Embeda and Troxyca approval.

"Food Specific" applesauce was used in the FDA Pamphlet for both ER Embeda and ER Troxyca capsules for some "mysterious swallowing" issue. No other opioid capsule has such a pamphlet instruction. The FDA CRL SequestOx because of a "Food Specific" solution.

Collegium Xtampza label also carries similar instructions for sprinkling pellets on food instead of swallowing whole capsules. There is a BENEFIT of being able to open the capsule and sprinkle the contents on food for people who have dysphagia or any other reason they cannot swallow whole capsules. It is completely unrelated to any pharmacokinetic measure, such as Tmax, and it is only listed as an option and a matter of personal preference. To make anything of it other than that is to conflate two completely unrelated issues.



Noted without further commentary: this week will be 90 days since the CRL, and still no updates to shareholders.