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To: Mark Bartlett who wrote (8109)	11/25/2001 5:43:33 PM
From: Cal Gary	Respond to of 14101

Chinese Aids sufferers stage mass protest By James Kynge in Beijing Published: November 22 2001 20:40 \| Last Updated: November 22 2001 21:48 Several hundred Chinese villagers protested this week outside a local government office demanding free medicine after claiming that botched collections of blood left them infected with HIV. Witnesses told the Financial Times that Aids sufferers and HIV carriers, mainly from the central province of Henan, began demonstrating at a government office in Chengguan town on Monday. Their demands had not been met by Thursday in spite of talks between local authorities and protesters, witnesses said. The Aids issue is potentially explosive for the Chinese government because there are numerous villages in Henan - more than 50 according to one local expert - in which a high proportion of the population has contracted HIV after the sale of blood in the 1990s to negligent companies often run by local officials. Dirty needles were regularly reused, spreading the virus. The blood collected was then often pooled, contaminating blood banks kept for transfusions. An almost complete ignorance of HIV and Aids in the region until recently contributed to transmission through sexual contact. The local population is poor and it was not uncommon for people to sell their blood 20 times a month, receiving about Rmb40 (£3.40) for 500ml, said Zhao Yong, an HIV carrier in Henan whose wife has died of Aids. In some Henan villages, more than 60 per cent of the population is infected, experts say. China has kept its Aids problem virtually taboo until last week, when it held its first international conference on Aids and acknowledged about 600,000 cases nationwide. Some health experts and one official newspaper said the government grossly underestimated the number of sufferers. The demonstration in Chengguan appears to have been prompted in part by the detention of a camera crew from CCTV, the official Chinese TV broadcaster, and a Beijing doctor, who were making a report on the plight of those infected. Residents welcomed the doctor and the journalists, believing they might help their quest for compensation and free medicine. But local officials, who stood to lose prestige and possibly their jobs, detained the visitors and expelled them from the area. The appetite for compensation has been sharpened by the publicised case last week of a court award of $43,770 (£31,011) compensation for a four-year-old girl in the northern province of Hebei whose mother died of Aids in 1999 after receiving contaminated blood following the girl's birth. news.ft.com

To: Mark Bartlett who wrote (8109)	11/25/2001 11:24:40 PM
From: Cal Gary	Respond to of 14101

Hi Mark, IMHO, from reading the NDA flowchart in detail, the approvABLE letter appears independent of the facilities inspection. The inspection affects the final approvAL letter. The results of the preapproval inspection may* also affect the final approval decision.* I find it curious why they would use the word "may". I was under the impression its 'does affect' the final approval decision, wether positively or negetively. Following your line of thinking, "If I were RK, and I did have an approvable letter,"... I would NR it to increase shareholder wealth. As CEO, that is one of my primary business reasons for being. Unless of course having a higher stock price is detrimental to some other business strategy. Only the insiders and FDA will know the state of the facilities inspection, and whatever deficiencies needed to be over come and how long it would take to remedy. The markets will not know any of this. Following your arguement, to wait does have merit. But IMO, that will lead to price erosion. Unless of course other material events occur, like Partner upfront cash, revenue generated cash, cash from other financing source. Without such, the hedging is only going to drive the price down until the inspection is done. Again this is not under RK control. The inspections can happen this week or 2 months from now. ie if they do not come by Christmas holiday time, then it'll be next year. So, if there is an approvable letter, then NR it makes the most business common sense. In the mean time, 1. the dilution aspect, of the hedging by the 3 amigos, would hopefully be less as the stock price moves to the next plataeu. 2. In another vein, we are sitting ducks for getting taken out early at a relatively low stock price. Our market cap is only $185mm canadian or $114mm USD. Some pharma's quarterly interest income exceeds our market cap. And that, to me, would be criminal! Did I mention that Calgary Stampeders are the 2001 Grey Cup Champions!! Yeeeehaaaaaaaaa. From the "Site Inspection Acceptable", there are 4 items on the purpose of conducting the inspection. I believe the first three items are check off list of items. The fourth item will take time to perform, most likely in an FDA lab in the USA. - verify the accuracy and completeness of the manufacturing-related information submitted in the NDA; - evaluate the manufacturing controls for the preapproval batches upon which information provided in the NDA is based; - evaluate the manufacturer's compliance with Current Good Manufacturing Practices (CGMPs) and manufacturing-related commitments made in the NDA; - and collect a variety of drug samples for analysis by FDA field and CDER laboratories. These samples may be subjected to several analyses, including methods validation, methods verification, and forensic screening for substitution. I also believe DMX fall under the following category: 3) that represent the first approval for the applicant; FDA: with great comfort and great confidence. Did I mention the block punt for a touch down?!!

To: Mark Bartlett who wrote (8109)	11/25/2001 11:24:40 PM
From: Cal Gary	Read Replies (1) \| Respond to of 14101

Hi Mark, IMHO, from reading the NDA flowchart in detail, the approvABLE letter appears independent of the facilities inspection. The inspection affects the final approvAL letter. The results of the preapproval inspection may* also affect the final approval decision.* I find it curious why they would use the word "may". I was under the impression its 'does affect' the final approval decision, wether positively or negetively. Following your line of thinking, "If I were RK, and I did have an approvable letter,"... I would NR it to increase shareholder wealth. As CEO, that is one of my primary business reasons for being. Unless of course having a higher stock price is detrimental to some other business strategy. Only the insiders and FDA will know the state of the facilities inspection, and whatever deficiencies needed to be over come and how long it would take to remedy. The markets will not know any of this. Following your arguement, to wait does have merit. But IMO, that will lead to price erosion. Unless of course other material events occur, like Partner upfront cash, revenue generated cash, cash from other financing source. Without such, the hedging is only going to drive the price down until the inspection is done. Again this is not under RK control. The inspections can happen this week or 2 months from now. ie if they do not come by Christmas holiday time, then it'll be next year. So, if there is an approvable letter, then NR it makes the most business common sense. In the mean time, 1. the dilution aspect, of the hedging by the 3 amigos, would hopefully be less as the stock price moves to the next plataeu. 2. In another vein, we are sitting ducks for getting taken out early at a relatively low stock price. Our market cap is only $185mm canadian or $114mm USD. Some pharma's quarterly interest income exceeds our market cap. And that, to me, would be criminal! Did I mention that Calgary Stampeders are the 2001 Grey Cup Champions!! Yeeeehaaaaaaaaa. From the "Site Inspection Acceptable", there are 4 items on the purpose of conducting the inspection. I believe the first three items are check off list of items. The fourth item will take time to perform, most likely in an FDA lab in the USA. - verify the accuracy and completeness of the manufacturing-related information submitted in the NDA; - evaluate the manufacturing controls for the preapproval batches upon which information provided in the NDA is based; - evaluate the manufacturer's compliance with Current Good Manufacturing Practices (CGMPs) and manufacturing-related commitments made in the NDA; - and collect a variety of drug samples for analysis by FDA field and CDER laboratories. These samples may be subjected to several analyses, including methods validation, methods verification, and forensic screening for substitution. I also believe DMX fall under the following category: 3) that represent the first approval for the applicant; FDA: with great comfort and great confidence. Did I mention the block punt for a touch down?!!