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Strategies & Market Trends : Anthony @ Equity Investigations, Dear Anthony, -- Ignore unavailable to you. Want to Upgrade?

To: Anthony@Pacific who wrote (45801)	10/26/1999 4:28:00 PM
From: Yak-attack	Read Replies (1) \| Respond to of 122087

I am taking a new approach on this stock, I have a core position short above 9 and I will add put options if it goes a little higher. Its obvious the insiders here are broke and they need money. Everyone knows they will dump stock to make money and its only a matter of time before this happens. I just find this whole run-up on this stock very intersting. I would like to know who this Doctor is and what connection he has with the company. It is just very suspicous thats all. What a sham this company is, for those of you that are intersted in options the Nov 7 1/2 puts are cheap and we have 24 days before expiration.

To: Anthony@Pacific who wrote (45801)	10/26/1999 4:32:00 PM
From: HeyRainier	Read Replies (2) \| Respond to of 122087

Hello Anthony, Do you have any thoughts on the Clarus(CLRS) pact with MSFT/CSCO? It was up 104% today. I was wondering if there were parallels with your previous short of Firstwave(FSTW). Rainier

To: Anthony@Pacific who wrote (45801)	10/26/1999 4:37:00 PM
From: Anthony@Pacific	Respond to of 122087

FDA Warning letter!! 00431143 DIOGENES Record Number: 193585 WARNING LETTER (REGULATORY LETTER) 10/18/93 TO SUNRISE TECHNOLOGIES: MICROPREP DEVICE; AMERICAN DENTAL LASER UPGRADE PACKAGE PP: 4. Device Classification: MICROPREP DEVICE. AMERICAN DENTAL LASER UPGRADE PACKAGE. Company Name: SUNRISE TECHNOLOGIES FREMONT, CALIFORNIA Source: FOI SERVICES FULL TEXT (FT). Publication Date: October 18, 1993 (19931018 ) Record Type: Fulltext Word Count: 762 (Short) Document Type: REGULATORY ACTION (REG). Language: English Oct 18 1993 Ira Fertik, Presiden 47257 Fremont Boulevard Fremont, California 94538 Dear Mr. Fertik: This is in reference to promotional materials distributed by or on behalf of Sunrise Technologies concerning your firm's MicroPrep device (K932977), including a "Dear Doctor" letter signed by Hilke Lazzeroni, a Marketing Manager for Dental Products. This letter was apparently sent in preparation for the DC Dental Society Meeting held this past May. This is also in reference to promotional materials distributed by or on behalf of your firm concerning "an upgrade package" intended to modify the American Dental Laser model dLASE 300 Laser, K931774. It is a violation of the Federal Food, Drug and Cosmetic Act (the Act) to promote a device of this type without 510(k) clearance. As with your firm's promotion of the upgrade package for the dLASE 300 discussed below, promotion of the MicroPrep has been done with full recognition of the uncleared nature of this product, viz. the statement in your firm's Press Release of April 19, 1993, "The parties expect to file a 510(k) for FDA clearance to market (this) product by the third quarter of 1993." We have also reviewed a document apparently sent to all users of the dLASE 300 Laser. The document, signed by two dental marketing managers, Kathleen O'Connell and Hilke Lazzeroni, offers for sale certain modifications to the referenced device, as an "upgrade package," prior to clearance of the referenced 510(k) submission. Since Sec. 513(i)(1)(A) of the Act requires clearance of a premarket notification [in this instance a 510(k) submission] prior to marketing, at the time of its dissemination, this document misbranded the product under Sec. 502(o) of the Act. Furthermore, since we are unaware of supporting scientific evidence, the dLASE 300 document is regarded to be false and/or misleading in that it represents and/or suggests that the modified device will be superior to the device prior to modification. Claims of superiority should be supported by adequate data. Failure to submit and receive clearance of a premarket notification of your intent to market a device in interstate commerce is a prohibited act under Sec. 301(p) of the Act, and results in the device being misbranded within the meaning of Sec. 502(o) of the Act. If a device is intended for other uses than those for which a 510(k) submission has been determined to be adequate, the device may be classified in Class III, requiring an application for premarket approval (PMA) to support its safety and efficacy. Failure to obtain approval of a PMA application prior to marketing a Class III device adulterates the product under Sec. 501(f)(1)(B) of the Act. This letter is not intended to be an all-inclusive list of violations concerning your firm's product line nor a complete list of violative products distributed by your firm. It is your responsibility to ensure that all requirements of the Act and regulations promulgated thereunder are being met for all your products before entering the marketplace. These are regarded to be egregious violations in view of the fact that the documents acknowledge the uncleared nature of the devices. Furthermore, taken together, your firm's activities with respect to these devices demonstrate a flagrant disregard for legal prohibitions against commercialization of uncleared products. Failure to promptly correct these violations may result in regulatory action without further notice. These actions may include, but are not limited to seizure, injunction, or civil penalties. We request that you reply in writing, within fifteen (15) working days of receipt of this letter, describing the specific steps you have taken to correct the noted violations including the lack of appropriate Premarket Notification (PMAs) and/or Premarket Approval Applications (PMAs) as required under the Act and related laws. Your written response should include a complete description of the nature and extent of distribution of the referenced products as well as a proposal of action to correct the false and/or misleading concepts already communicated. Your response should also describe the steps that you have taken to prevent the future issuance, by or on behalf of your firm, of promotional materials prior to receipt of appropriate agency clearance. It should be directed to Byron L. Tart, Acting Director, Promotion and Advertising Policy Staff, 2098 Gaither Road, Rockville, Maryland 20850, HFZ-300. Sincerely yours, Ronald M. Johnson Director Office of Compliance Center for Devices and Radiological Health