boost for global diclofenac gel market, page-8

Southoz-

To the best of my understanding, the US FDA safety concerns regarding diclofenac are limited to ORAL diclofenac. But, it appears to be the case that the US regards any form of diclofenac with a level of concern that exceeds that in most other parts of the world, including Australia and Canada, where topical diclofenac products are available OTC.

This has nothing to do with less rigorous drug approval processes in Australia or Canada -r India for that matter; it has only to do with an over abundance of caution by the US FDA.

And yes, TPM diclofenac approval in the USA is not on the cards absent appropriate human clinical trials. I doubt that these trials would be any more expensive or difficult to conduct than the present oxycodone clinical trials.

The real reason that the company is not funding topical diclofenac trials on its own knick right now is the same reason it is not funding insulin trials or fentanyl trials or lidocaine trials. The company is putting its resources to work where they can do the most good, and other projects are back-burnered. Welcome to the real world.

I think you are mis-reading the present situation and as a result your comments are wide of the target.