United Health Products Inc (UEEC)

[Waverunners]

Hopefully they just need to prove the ability to produce the product.
Meaning, proof that they have sourced the appropriate raw materials and have an approved sterile manufacturing facility on contract.
For example, a manufacturer such has Strouse has already proven to FDA a that they can manufacture sterile bandages so the process would go much smoother with a reputable like Strouse.
Personally, I feel UHP needs to take as much time as it takes to get it right and then they will be approved.
There’s no more room for cutting corners on this submission.

“ their comments were very helpful and we conclude that the validation of certain elements of our manufacturing process are necessary to assemble a complete portfolio of information that the FDA can then use to complete its review our PMA application. We will work expeditiously with our manufacturing partner in the coming weeks to accomplish these remaining tasks.”

Hopefully 3 months for the paperwork portion. Then the review. Don’t rush it UHP. Just get the approval.