Seems to me that there is too much blame of Whalen - he is only the CEO and will not figure in the decisions of the FDA.
The FDA is the government agency charged with the responsibility of protecting the public involving hundreds of thousands of products, millions of claims and every comma and hyphen. FDA employees are people with jobs, just like us, but with a bigger responsibility - protecting us from harm. So, my opinion is Whalen and investors here have nil effect on the FDA.
A buddy advised me that what matters is the process of assessing data as part of applications for approval. Millions of items of data in hundreds of thousands of applications, usually on a first come, first served basis, unless an application warrants a fast-track designation. He went on to say that smart people tet the FDA follow its process, without being alienated by pests and indignation.
With the simple, straightforward, NORMAL, everyday FDA warning letter as to compliance, my buddy said BIEL erred and corrected its position and activities after receiving the letter to get itself back into compliance. The system works and BIEL staff admitted it had made the changes necessary to comply. We have not heard a 'no' from the FDA - BIEL has a 'yes' from the FDA on RecoveryRx, so don't we just let the process eveolve? Am I crazy, or do we simply have to be patient and just ignore the ignorant naysayers? The product works and is approved on post-op eye surgery patiens by Rx. Isn't the logical next step OTC for other indications that may help us all? I've used ActiPatch on a badly sprained ankle and know it worked amazingly on me. Anything else in nonsense!
