Nexus Energy Services Inc (IBGR)

[Bucks4Buckeyes]

CHEYENNE, I am certainly not an FDA expert, but both of us have been researching on Aquaprin for quite a while.

Here's how it all SEEMS to me:

1. Because Aquaprin is listed under already existing monographs, it does not need individual approval from the FDA.

2. YES - the FDA must approve every piece of equipment, storage, packaging, sterilization and every batch produced must follow stringent Quality Control tests - this is the Current Good Manufacturing Practice Regulations (CGMP) which is referred to on PharmStar's website.

3. NO - the way I understand, the 3rd Party claims testing has nothing to do with the FDA - but the FCC, which may slap some kind of penalty on PHAR for false advertising, unless they have made a valid claims test concerning the effectiveness of Aquaprin vs. Bayer or Tylenol.

4. YES - the FDA must approve the facility, machines and product for Aquaprin to be place on the U.S. markets. HOWEVER (maybe just an idea) I do not know if the same requirements would be needed if the first batch of Aquaprin was manufactured and sold to a foreign country (as per distribution agreement?)- perhaps enabling more funding to come in to complete the purchase of building or advance to complete all required FDA regulations? Just a thought.

5. I am very anxious to hear progress on the plant and facility, myself, too.

Furthermore, Howard has been through the FDA process before and understands it very well. Yes, I do have validation for that, too.

All The Best