A little harsh on M.
This whole thing is about money. Period. The FDA is the/a gatekeeper. I see their job as one to provide rules/laws which control the development of products medical devices and Pharma's. They do this by keeping their jobs and not simultaneously pissing everyone off.
BP has all the money and will sell anything to anybody as long as they do not get sued. FDA tries to write rules and draw the line which allows sufficient financial incentives through process controls/rules which we know as regulations. But, it is really all about money. BTW, the ONLY people with enough money to follow these rules are in BP. So, there it is, a standoff. This can be known as the SWAMP.
Now, how is a company like AVXL going to make it through the SWAMP of corruption and maze of rules w/o getting eaten alive? Good question. Keep in mind the ONLY people who really care are the patients and their families and shareholders. All the rest of are a kind of observers/baggage. Sometimes they help, like MJF foundation does as 3rd party watchdog.
We are stuck in the swamp along w/M and the whole lot. You should assess the rules guys also. Just what the hell is the FDA doing anyways? It is clear the process so far has produced more of the same. The process only functions to avoid disasters and to save/keep jobs in BP and FDA.
I am somehow confident that A2-73 will make it through but it will not be by following these rules sadly (See Aus/EU). If anyone will make it M will.IMO.
