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2Relax

11/29/18 10:22 AM

#162153 RE: Rayland #161981

WHY GUESS? or Hope? Bring the dream team back into the picture and IMHO we will get approval much faster? Does anybody doubt this?

This is where the leadership is WEAK! why reinvent the wheel?

FDA has undeniably mistaken this little company as their punching bag for WAY TOO LONG. FDA attorneys at Goodwin Procter are heavyweights. At least have them review what Sree is preparing prior to another submission.

I think its OBVIOUS that the FDA is now in PROTECTION MODE, maybe the big pharma companies are expressing more concern now that Bayer / scholls is in the mix, and a top 5 medical company is at the table (dont know who).

This may drag on for who knows how long, until you bring in professionals that no how to deal with the FDA BS!

Just my 2 cents