Ann: US patent allowed for Sygenus for acne, page-7

phillip_k

I believe the answer to your question is yes!

My understanding is that TGA and FDA have different approval standards for topical materials depending on whether they are to be marketed as a medicine or a cosmetic. In that regard, I suspect RGS has shown its hand in its update from a few days ago when it stated that:

"We are currently undertaking a number of preclinical studies for topical application of the secretions for cosmetic applications and anticipate results by the end of September 2017"

So, if my understanding is correct, RGS will be seeking approval for the acne treatment (if the trial is successful) under TGA and FDA regulations applicable to cosmetic applications. This should mean much quicker and easier approval than if the company was seeking approval for the acne treatment as a medicine. The caveat is that if approval is gained for the acne treatment as a cosmetic application, it cannot then be marketed as a medicinal treatment by attendant spruiking of therapeutic medical benefits. However, if the application works well for treating acne, who cares - it will almost market itself.

Incidentally, I was pleased to see that the company update clarified the completion/results date for the preclinical trial of the stem cells secretion gel for treatment of acne.

zeno9