o what we know is that Elite is developing MIK001’s formulation, analytical methodology, and manufacture, test and release the clinical supplies necessary for clinical trials and NDA approval. We further know that Mik001 will be a 5052b NDA.....and that Elite announced that it would be developing Mik001 in the same PR in which Elite obtained Naltrexone from Mikah via Actavis.
What we also know is that Mik001 is without question an Abuse Resistant Opioid. Why would a pharmaceutical company come to Elite and ask Elite to develop a drug without that drug being one that Elite specializes in developing. It wouldn't!
So put these things together and we get that Mik001 is an Abuse Resistant 5052b NDA Opioid using Naltrexone. Seems we are getting close! And what part of the 5052b would be noteworthy considering MIK001??? ....
The 505(b)(2) approval route can be utilized for a wide range of products, especially for those that represent a limited change from a previously approved drug. The following are examples of changes to approved drugs which would be appropriate to submit as 505(b)(2) applications:
Changes in dosage form, strength, route of administration, formulation, dosing regimen, or indication
Now you take these pieces of information and look at the six Abuse Deterrent products on the market: Which of these products is the most similar to what Elite's 216 process is??
Well, probably the product that comes closest to it is a product called Embeda, which is a sustained-release morphine product that has a naltrexone, an antagonist sequestered in naltrexone associated with it.
2) Embeda (Whoops No It Isn't))
Now you add in that Pfizer sues Watson over Embeda patent infringement and wins. That Actavis previously manufactured Embeda and then Watson purchases Actavis. Now Actavis has had to divest their right to manufacture Embeda and then Mikah hires Elite to develop Mik001.
Sentiment: Strong Buy