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Sunday, October 25, 2009 10:24:43 PM
See this part from an article I came across:
It’s not hard to see why the FDA, chronically understaffed and under-funded, took the expedited route to approving devices. According to the GAO report, FDA generally makes decisions on 510(k) submissions faster than on pharmaceutical submissions (the agency reviews and decides on 90% of 510(k) submissions within 90 days, compared to 90% of original pharmaceutical submissions within 295 days.) The estimated cost to the agency for a 510 (k) submission was about $18,200 in 2005, vs. a whopping $870,000 for a drug submission. Of course, medical device manufacturers have similar time/cost concerns when choosing how to apply for approval.
This might speed things up considerable.
I assume that soon after completion of the merger they will start the application process with the FDA, so we could see the approval as soon as March 2010 (rough guestimate)
This is going to be one helluva ride. It is still not too late to get in IMHO
I have taken a substantial position over the last 4 weeks but am very tempted to sell all my other positions and put it all in XMDC.
I will have to sleep on that one lol
Ready for monday morning 9:30
Good luck everyone next week and thanks Rainmaker for all the great DD you supply to us.
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