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PashkaVl

11/27/18 3:52 PM

#161558 RE: mtoronto #161544

And again thank you for your calm and steadfast insight!

Seems hard to fathom that they can lose the approval while winning the innovation challenge, but I'm sure it's a different analysis and people involved...

It would be truly Karmic if another division in the FDA grants access to the innovation challenge, while quickly throwing mud on the face of the 510K panel that rejected the Actipatch. In this scenario the media might actually start asking pointed questions about why this technology isn't being used more extensively in the US.

Simpsonly

11/27/18 5:19 PM

#161613 RE: mtoronto #161544

No one likes a 50% kick in the slats, but as has been said, things are not always as they seem. The GG&G have been busy today and we now know who at FDA is the probable source and who at NDA has no idea this happened, and should have been advised long before such a decision was made.... We also believe we know next steps and believe we will be fine. One thing we do not do is shoot from the hip or the lip....not one share sold....sleepin like a baby...

Tropicalstocks

12/02/18 9:02 AM

#162871 RE: mtoronto #161544

Mtoronto we got the results from the FDA challenge. Now what?