Nanny,
Spoke to Susan this afternoon and without being specific she confirmed
"all is going well on the financing," but they are not ready to announce YET.
Tonight, I had nothing to do, so I downloaded the FDA's ophthalmic device panel
minutes from 7/11/97 where PMA P970001 for Emory LASIK system was being presented for approval. After reading through the proceedings, almost when it was time to vote, an issue came up that would seemingly weigh heavily in SNRS favor. That issue deals with a patient questionnaire having influence over the final outcome. Let me quote (pg. 234 if anyone has the minutes):
" Will the results of patient questionnaire influence the panel's recommendation regarding approval of this device?
Dr. Macsai: Yes
Dr. Van Meter: Absolutely
Dr. McCulley: Unanimous yes."
Nanny, I hope Dr. Akers and the others doing the clinicals are aware
of the significance of patient feedback in obtaining FDA approval.
Like you said, patients LOVE this quick, easy procedure...
Can you check if this is being documented via a patient questionaire?
The bottom line was summed up by Dr. Eve Higginbotham who stated "Although I'm not happy with the follow-up and the lack of patient satisfaction data, I recognize that this is a significant adjunct to the refractive surgery armamentarium, and certainly the marketplace is begging for LASIK. Like many of my colleagues, I think it's in the public's best interest to move this technology along, and I'm happy to play a part in doing so."
IMO, SNRS YAG laser will do a FDA fly-by. BTW, I happen to have made
an appt. to get my eyes checked out tomorrow.
Nanny, as you are woman, so is my Dr.... Now ain't that a coincedance.
Regards,
Skane |
