Elite Pharmaceuticals Inc (ELTP)

[WeeZuhl]

Sounds like a reformulation.

They have given us a date to meet us in the third week of December. We believe that our proposal will address the FDA Tmax concern, and if they agree with our proposal and we will know that next month, Elite will complete additional work and a fed BE study and target resubmission in 2017. We will know more after we meet with the FDA.

If there is additional work AND a fed BE study to be done, then most likely the additional work is a reformulation of the SequestOx agonist bead to make it right, and I hope that is a true assessment on my part. The ADF label imparts on a drug an important and coveted distinction, and it deserves the highest quality product possible. Make it right, and docs will prescribe it. "Target" 2017 means a few things to me. First, the co. proposal to FDA will be to leave the HAL studies in tact. The antagonist bead is unchanged, so no need to repeat the HAL studies. That would be very advantageous in terms of time & money. But also "target" means "we hope" which means late 2017 maybe, if the FDA agrees.


Although he only spoke in generalities, I liked what I heard about the ADF pipeline. Not just SequestOx, but also that the ER line-up has not been forgotten. SequestOx was to be a quick validation of the tech, and having failed that for non-systemic reasons, we cannot lose sight of the ultimate goal, which is a pipeline of long-acting abuse-deterrent opioids. NH clearly stated he intends to use the ANDA pathway for ELI-201 once the Pfizer product is available for bioequivalence comparison. This will be a cheaper route than 505b2 NDA, but with many questions about time to approval and ANDA exclusivity unanswered.

As I have updated you before, Pfizer received approval for their oxy with naltrexone ER using the same technology or similar technology as we do with pharmacological approach. But they have not launched yet. We cannot compare our product and create a formulation [Indiscernible] without them launching. Then we will have access to this product. So as soon as the product is available, we will do what needs to be done to file an ANDA.