To: Don W Stone who wrote (220 ) 1/16/1998 1:06:00 AM From: Don W Stone Read Replies (1) | Respond to of 507
To all: Here are some comments that were recently attributed to "Liz Greetham, portfolio manager for Weiss Peck & Greer" which should be conforting to any NVX bull. For those who aren't aware of it, this I think is the second largest institutional holder of NVX stock. Those that know Liz Greetham have told me that she is very well respected on Wall Street. She said that she does not think that this latest FDA request for information will turn into a major skirmish. Greetham said that this data request came from the FDA division that oversees biological drugs, which is clamping down on its manufacturing requirements. She said that NVX's competitors that have pertussis products on the market got warning letters about manufacturing from the FDA. She said the data the FDA wants isn't safety or efficacy data. She said that it is her understanding from conversations with Abbott and NVX that the Label is done. That the request for information is probably an analytics question. I have only tried to convey what I think she mite have tried to convey in a recent interview. Now here are my comments. What is significant here is the comment that the FDA Biologics group is clamping down on its manufacturing requirements and that all of NVX's competitors got "warning letters" from the FDA regarding manufacturing. I have heard that they got them recently. What this is about at this stage is perhaps premature but my best guess is the older manufacturing companies i.e. Connaugh, SKB, Lederle, are being required to meet the latest FDA manufacturing requirement.( I liken all this to like dealing with local or state fire codes , etc. abit more stringent I would hope and assume.:-} ) How difficult will it be for the older companies to meet the new requiremnts is up for contemplation.( bringing an old building up to todays building code sometimes means , teardown) Meanwhile I would say NVX who in the last two years has been meeting regularly with the FDA and completed and put on line the most advanced manufacturing facitity in the world to produce their pertussis vaccine should be able to readily conform . If I really wanted to take this to the extreme I could argue that NVX just could become the sole source provider of pertussis vaccine by default. My point is that I am hearing that many think that this lastest news release, this request for more information from the FDA just may be related to the above and concerns a notice of a new standard or procedure involving manufacturing of the pertussis vaccine that can be readily met by NVX. It can't be all that bad if the Company is saying that the information is in house and that all of it will be in the hands of the FDA over the next two weeks. Enough for tonite. The shorts i am told shorted over 50,000 shares today in their effort to drive the price of the stock down. They know their window is very small. This is why they are out USING the media. The time to BUY is now. Make them pay. Of course if a big holder just calls his stock this situation will reverse.