Rivulet Media Inc (fka RIVU)

[PG]

I would like to share an answer I provided a member this morning in a private message. There are a few modifications. But the meat of it is contained below.

Please note that the contents of this message is very much relative to BMSN as it is a response I provided to a request for my professional opinion as to when I think FDA approval for HemaXellerate can be expected:

I wish I knew or could really speculate. If the FDA put in place a proviso, stipulating Regen had to wait for physical or verbal confirmation or denial during the first round of Q&A, lord knows how long it could take. I don't mean years, mind you. But, the government is all screwed and people are not doing their jobs. This is the most inefficient band of civil servants I have ever had the misfortune of knowing.

I will give you a case and point: I received insider info on very pertinent information for a particular drug marketed by a very large BP. The info was about an alarming number of patients dying from anaphylaxis within the first thirty minutes of receiving the marketed treatment. It was an anomaly, happening only in Tennessee, Virginia & West Virginia at that time. I was told about this by someone working directly with the BP who had just quit her job with said BP because she was instructed to either shut up or get out--that the data and additional info for this anomaly doesn't actually exist.

So, she quit.

Since she had divulged this to me, I had a legal and moral obligation to report what I was told directly to the FDA. I did so using the contact numbers that I had through work and attempted a second complaint anonymously. I BS you not when I say, I could not file a complaint anonymously; there was no live person to talk to in the complaints division, only recordings. And when I pushed the matter, repeatedly going through their main call center, I always found myself talking to a less-than-concerned, civil servant, that could not adequately articulate the Queen's English and never had an answer to my questions. She insisted, "just keep calling back until you get someone".

For two days that "someone" never answered.

It amazes me that people think because it is posted on the FDA website as being protocol, such protocol is followed. Not even close.

Personally, I am amazed that they made it as far as they did as fast as they did with the FDA. That tells me that they included one kick butt report with their application.

Personally, I am rather impressed. And I don't say that because I have so much vested in them. I say that because I know first hand, in more ways than one, what it is like trying to work with the US government in 2013. It's no fun. It's hard work.

BMSN