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Biotech / Medical : SNRS- Sunrise Technologies -- Ignore unavailable to you. Want to Upgrade?

To: BigAppleBoy who wrote (2962)	8/4/1999 7:12:00 PM
From: Gordon A. Langston	Read Replies (1) \| Respond to of 4140

BigappleBoy The panel process is flawed.. Only if no one cares (has a financial or ethical bias) will it be able to look at a presentation in a fair way. The FDA has arranged a blind date for you. They are saying to bring flowers and candy, specifically roses and chocolate. A dozen of the former and 2# of the latter. You arrive at the date and she is not impressed. "Where are the long stems?" Gulp! And "Are these just plain chocolate? I prefer the ones with the nuts!" I'd like to think the FDA made every effort to assure that SNRS got a fair hearing and it indeed might be true. It would seem like they are in control of the type of data that is to be submitted and the numbers of patients. In fact, if this is a hoop that companies like SNRS are to jump through, someone has to set the objectives to be satisfied, otherwise it is an extremely risky proposition to invest so much research and money and time only to face a panel that is able to play the "subjective card" When is the last time you took a math or science test and were graded subjectively on the answers. There are only three players in this scenario; the ODP, the FDA and Sunrise. Sunrise is the only one taking any risk here. Can we say the FDA did their best and just didn't guess correctly about the data that the ODP wanted? What does the FDA do but set the parameters for approval, afterall they must eventually give their "own" approval based on this panel's recommendation. It is not hard to see that the FDA and Sunrise would have been better off getting this approved in a less formal but more scientific way. In retrospect it seems like the lottery. As long as safety was not an issue, the rejection makes less sense. My main point is if the FDA is to give final approval, it must at least have asked for enough of the right data to have made a decision of their own, not withstanding the panel's recommendations. If they have the ability to override the panel based on the available data, then the data they ask for must be intrinsically adequate. If we are to believe the scenario as it has taken place, then the FDA has asked for the data, assembled it in a form that either they or the panel has determined is best and yet saw no reason to question the regression themselves. Either that or unknown to us the company went ahead with the presentation even though they had some knowledge of a regression issue. Quite a risk. Everything else points to panel bias. Reasons for this could be many but none reveal fairness. Just my two cents worth after a lot of reading. Gordon

To: BigAppleBoy who wrote (2962)	8/5/1999 8:19:00 AM
From: gbh	Read Replies (1) \| Respond to of 4140

but SNRS?If the company had the approval SNRS would trade 30-50 dollars or even higher and may had never seen the teen's again The stock seemed maxed out at 20'ish based on comparative market cap with BEAM, who already had FDA approval. Its possible the stock would have "sold the news" anyway (obviously not down to single digits). Lets face it. The stock traded up to 20 on hype. The fact is they still wouldn't be generating revenue yet, even with a panel OK. 30-50 was at least 6 months to a year away, provided sales had met the hype, which was not a given. ....so theydid not take a risk,they knew the panel's desicion ahead of time,period. I agree. Someone at the meeting posted on one of the boards that one of the panel members showed slides reading "recommend non-approval". If the slides were prepared ahead of time, the info probably leaked out.