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Biotech / Medical : SNRS- Sunrise Technologies

SNRS 0.00

Dec 18 4:00 PM EST

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To: Sylvester who wrote (1442)	8/11/1998 1:12:00 PM
From: Joe	of 4140

Where do we go from here? The progression of a medical device through the FDA's PMA process is instructive. From where SNRS is now we will see the following probably by midyear 1999: 1. FDA notifies SNRS there must be data for X number of patients at the 1 year follow-up with the PMA. This tells SNRS when they have an acceptable amount of data for their submission and when they will be able to file the PMA. The estimates I have heard are by the end of the year for the filing. It is possible that this may slip into the 1st quarter, IMO. 2. The PMA is reviewed internally in the FDA and then it is distributed to the Ophthalmic Devices Panel members and placed onto the Panel agenda. The meeting date chosen is determined by how long FDA allows for reviewed by panel members. IMO it will be the April meeting. 3. The panel meets and SNRS will either get a recommendation to the FDA for approval or for conditional approval with more data. Recommendation will probably be conditional unless submission and data are perfect. 4. The FDA will then either approve within several months of the panel meeting or they will get the additional data from SNRS and then approve. There will be a number of other news events. These will include other indications for use submitted to FDA and the initiation of clinicals. There are also the other indications that have already been started that we will be seeing news on. With each of these news events we will see a bump up in stock price. From item 4 above onward, the progression of news will be about the same as what we saw for VISX since September of 1995 when they got approval. You will need to hang onto you hats for each of these events but when per use fees overtake equipment sales like recently occurred with VISX, look out. We will all be in Boca probably when approval occurs. When per use fees news occurs, we will have our own yachts in Boca. Regards, Joe

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