To: CatLady who wrote (939 ) 6/8/1998 9:48:00 AM From: JanyBlueEyes Respond to of 4634
Here you go 7/30/97 FDA approval - which gave the company the credibility to spark the interest of the internationally well-known companies for the opportunity to distribute the device. The due diligence process alone is time consuming and very necessary to ensure the fundamental issues are fully understood by all concerned and surprises won't surface during the next step involving the tedious legal process of drawing contracts. During that initial phase after FDA approval, as they were trying to wade through all of the interest generated, they were working on remaining regulatory requirements, such as -getting the operations and training manuals together -promotional materials for commercial systems -software programs for different markets prepared and submitted -complying with any applicable federal, state and local regulatory guidelines -obtaining all foreign and any remaining U.S. regulatory clearances for commercial marketing -preparing the warehoused instruments ready to ship under GMP quality systems Not to mention, speaking with interested institutions, investors, etc. All of this takes time. Then in December, 1997 we have the addition of Fred Frank of Lehman Brothers who brought along with him even more potential distributors for the company, more due diligence, more talks. Also during this time, she added Dr. Maisels and Dr. Holzman to the Medical Advisory Board. Dr. Maisels is a world-reknown pediatrician who has written extensively on hyperbilirubinemia. Showing his support is another important factor to judge the validity of CCSI. In the first part of 1998 while running the day to day aspects of the growing business: They had to get together the manufacturing aspect of the device. That means: every little part being arranged to be manufactured and then arranging for it to be put together. This takes time also. While that was going on they were conducting research and interviewing potential candidates for PR and Auditor. These people don't just drop from the sky. Then we have the addition of Hill and Knowlton as public relations and BDO Seidman as auditors. They were also getting a booth and literature together for the "roadshows" - the first was in New Orleans - they were the hit of the show - the next one is in China this week. They are also going to present the device in Beijing at two hospitals....you don't do that without permission from the Ministry of Health - China has over 20 MILLION births each year. Now we are down to the last few hours before a distributor announcement is made - A BIGGIE from what I am hearing. This company a sham????? I don't think so.