Elite Pharmaceuticals Inc (ELTP)

[guti]

My thinking to the FDA objection at this time might come from the lack of information from the CEO and the known information when combining naltrexone.

There are major concerns by doctors when prescribing naltrexone, to ensure the treatment is safe on a patient. Blood tests are usually obtained prior to initial treatment with the drug, followed by retesting which generally occurs at monthly intervals for the first three months, with less frequent testing after that point. More frequent testing may be requested depending on the health of the liver prior to beginning treatment. Blood tests are needed to make sure that liver function is adequate prior to taking naltrexone and during, to evaluate whether naltrexone is having adverse effects on the liver. In addition, a patient should inform their physician of whatever medication they are currently taking so that possible interactions can be evaluated. Because naltrexone is broken down by the liver, other medications that can affect liver function may affect the dose of naltrexone.

Those are problems that need to be a dressed before a doctor deals with a pain by prescribing SequestOx, in case the patient consumes alcohol and the naltrexone gets released. All that can cost time and money to insurance companies as well as it creates a bigger burden to doctors.
Again, since the CEO lacked information, I have to gather my own in order to make an intelligent decision. If anyone can better explain the above, your response is welcomed.