HIGH SPECULATION??
It's been over 24 hours since the ODP decision. I've been through lot's of different emotions in these past 24 hours. Lot's of butterflies in my stomach, intermittent nausea, diarrhea, anger, self pity, etc., etc....trying to figure out what went wrong yesterday.
My investment in SNRS was much more than speculation......I was semi-directly involved. Back in September 1997, more than 6 of my patients had LTK performed by virtue of my referral to an FDA test center. I watched the procedure but was not involved in the follow-ups that were performed at the investigational center. I took it upon myself to periodically call back my patients at no charge to them so I could first hand witness the results of LTK. I had heard about LTK 6 months prior and although many of my colleagues were invested in SNRS at prices under $1.00, I chose not to until I had hands on experience. My lowest purchase price was $3.00 and I recently added on Wed. at $15.
In following my patients, the one common denominator was that they were all very happy. One husband thanked me profusely for his wife because she can now put makeup on in the morning without magnifiers. Another now plays tennis without glasses and can still read close up. Not bad for 22 months out and before the new drying procedure!
Something really stinks here.
SNRS filed for PMA in December 1998. The FDA had plenty of time to request additional data. The FDA placed SNRS on the July panel. The FDA approved second eye testing for higher powers. SNRS was in constant touch with the FDA. How does the ODP know that at 24 months, regression occurs to unacceptable levels? Weren't they supposed to evaluate the data presented??
What will VISX/BEAM data reflect in 36 months?? 48 months?? 60 months?? I personally know of horror stories with Hyperopic Lasik -- and that is out of one center I refer to. And, its' not the center or the surgeon.....it's the procedure! One patient went in 20/40 and ended up 20/200 and at 3 months she is now 20/40 again. This case can not be explained, yet! They think it has to do with age. Great..huh? Hyperopic Lasik gives different results with different ages! Wow....where was the ODP??? Should they do a recall??
If the ODP wanted 24 month data they should have requested it before the FDA put SNRS on the July panel!
How can 7 human beings have so much power? Not one of them had a dissenting opinion? SNRS met and exceeded all the criteria required at 18 months. What's the problem? Can this be personal? Political? Financial? Maybe the ODP methods should be investigated by a independent special council? Aren't there regulatory rules and protocol they must follow?
I hope and pray SNRS informs shareholders of a concrete gameplan after all the final dust settles next week.
Secondly, they should continue to gather the final 3 months of data and keep in close contact with the FDA.
Thirdly, they should continue their legal case against Sturza, et al (whose claim to fame was that the SNRS hyperopia market was very limited-- even though it encompassed 90%--and would fail commercially) and expand it to investigate all the ODP members and their financial investments and employment/consultation agreements!
Wonder what stinky relationships might turn up??
P.S. LTK WORKS AND PATIENTS LOVE IT! |
