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To: twentyfirstcenturyfox who wrote (7804)	10/7/2001 12:02:22 PM
From: DaveAu	Respond to of 14101

One other note on the Thailand issue: WF10 was not approved for AIDS but rather for radiation exposure if my memory is correct. Although doctors would be able to prescribe it for other things, I don't think the available evidence would convince many of them to do so (Dr. Pugen notwithstanding). Dave

To: twentyfirstcenturyfox who wrote (7804)	10/7/2001 1:52:33 PM
From: Joe Krupa	Read Replies (1) \| Respond to of 14101

Fox, "We are warming up our marketing, packaging and so on, for the Canadian launch. But did Rebecca not say 'North American launch"? Why would the company be spending expensive money (aka cheap shares), when a major marketing USA partner would be capable of throwing 5-10 million at a (USA) launch?" The reality remains that there is money coming from somewhere, beyond Acqua. We've been out of money for a couple months now and all we took from Acqua is $1 million. I don't believe that it's coming from UK sales, outside of the $700k guaranteed quarterly shipment to the Provalis. The burn rate is rumoured to be much higher than the amount of money we can account for. In addition to the on-going operating expenses, Dimethaid is now undertaking large upgrade/expansion of the Varennes plant, as well as doing all the prep work for the Canadian launch (including hiring all the new sales reps). Given the upfront investment of marketing to a country like Canada on its own, I would suspect that this plan would have been abandoned (in favour of a partner) were sufficient cash an impossibility in the near term. From what I understand, the process continues as is. So my guess is that the FDA is very much in play. In fact, it would not surprise me if Rebecca is in possession of an approvable letter (or equivalent) from the FDA which still requires a few conditions to acquire final approval. Below is a Reuters press release outlining the FDA approvable letter, received by Eli Lilly this week, for its osteoporosis drug Forteo. Note that there are still several conditions that need to be met prior to final approval, including plant inspection, labelling issues, and agreement on proper use of the product. Considering Rebecca's confidence about FDA during her August ROB-TV interview, it might not be huge stretch of the imagination to think she has something similar to an approvable letter, in hand. Just a few thoughts. ******************************************************** Lilly Gets Approvable Letter For Osteoporosis Drug** -------------------------------------------------------------------------------- NEW YORK (Reuters Health) Oct 03 - Eli Lilly & Co. said during a conference call on Wednesday morning that the US Food and Drug Administration (FDA) has issued an approvable letter for the company's osteoporosis drug Forteo (teriparatide) for use in men and postmenopausal women. The approvable letter comes despite the split vote of an FDA advisory panel on whether to recommend the drug for men with the disease. The panel unanimously supported the approval in postmenopausal women. According to the Indianapolis, Indiana-based drugmaker, final approval of Forteo is contingent upon labeling negotiations with the FDA, agreement on measures to ensure the proper use of the product and the inspection of manufacturing facilities. Lilly said that while it has already requested the FDA inspect Forteo manufacturing sites in Indianapolis and France, and that discussions with the agency over other issues are ongoing, it could not accurately offer a time for approval and product launch. During afternoon trading on the New York Stock Exchange, shares of Lilly were down 4.67 at 78.02, as investors reacted to the company's lowering of its third quarter earnings guidance earlier in the day. --------------------------------------------------------------------------------