DNAprint Genomics (DNAG)

[frogdreaming]

Nonsense.

FDA guidelines are not directed at product requirements, those are the responsibility of the manufacturer. What the FDA demands is that both design and manufacturing practices ensure that those requirements are met.

The FDA guidelines for manufacture are spelled out in the GMP (Good Manufacturing Practice). They also provide guidelines for design practices.

Those guidelines require simply that all requirements are specified at the beginning of the design phase and that the company's design process spells out how those requirements will be met.

FDA approval will not be granted until those requirements have been met and verified with statistically significant analysis.

Gabriel has specifically stated that Ovanome does not yet meet DNAP standards and is not yet ready for the FDA. That means, in no uncertain terms, that the product does not yet meet it's own design requirements.

If 95% is the design goal, perhaps they can't meet that level of accuracy, or perhaps they can meet it but not in a reliable and repeatable manner. Whatever the obstacle, the company has clearly stated it's status. It does not yet meet it's requirements and therefore is not ready for the FDA.

regards,
frog