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To: Cal Gary who wrote (8547)	1/28/2002 12:29:31 PM
From: VAUGHN	Read Replies (1) \| Respond to of 14101

Here you go Cal Government Claw Backs Major Cause of Drug Review Delays Canadians Forced to Wait for Best Medicines AYLMER, QC, Jan. 28 /CNW/ - Canadians wait two years longer than citizens of the U.S. and Europe for access to new drug treatments, because of a huge backlog at Health Canada. Officials from the Therapeutic Products Directorate (TPD), the arm of Health Canada responsible for drug review and post-market surveillance, told delegates at The Canadians for Best Medicines Summit there is a delay of 18 months or more before anyone at Health Canada even looks at new drug submissions. However, once the submission gets out of the massive in-box and into the hands of a reviewer, Canada's review process is comparable to the U.S. and Europe. "It quickly became clear at this Summit that when the cost-recovery program came in, taxpayer money went out. This crippled the drug review system and is causing Canadians to wait even longer for the best medicines," said Pat Kelly organizer of the Summit and chair of the Cancer Advocacy Coalition of Canada. "This issue could be an early win for the new Minister of Health." "Instead of advocates slamming bureaucrats, they hammered out solutions with senior staff from Health Canada," said Kelly. "Now our elected officials need to do their part and put back the $70 million they bled out of the system." The Canadians for Best Medicines 2nd National Summit on Reform of Canada's Drug Review System represents a breakthrough in public participation in this policy area. The Summit brought together a broad base of grassroots delegates from consumer and advocate organizations across the country, as well as industry and Health Canada, to develop a strategic action plan to ensure Canadians gain safe and timely access to the best evidence-based medicines. The Summit also included Canadians who shared their personal stories about struggles to gain timely access to necessary medication. Major topics of discussion during the Summit included: - Funding - Just put it back - Marketed Health Products Directorate - Fund the post-market surveillance system - Meaningful consumer representation in the review process "Medication, in terms of healthcare, is critical," said Denis Morrice, President and CEO of The Arthritis Society. "Access to the best and most effective medications will actually cost the system less as it allows people to lead productive lives, to keep working and to contribute to the economy. We need to work together to correct the situation and ensure transparency and consumer involvement." Delegates included representatives and consumers from Cancer Advocacy Coalition of Canada, Arthritis Consumer Experts, the Colorectal Cancer Association of Canada, the Canadian Lung Association, The Arthritis Society, the Canadian Diabetes Association, Canadian Cretzfeldt Jakob Society, the Huntington Society of Canada and the Canadian Breast Cancer Network. "The TPD needs staff and financial resources to get rid of the backlog and to meet its own target review times. There is no excuse for letting people suffer needlessly as a result of these delays," said Kelly. "Access to the best medicines will keep people out of emergency rooms and hospital beds and let them get back to living their lives." The Coalition for Best Medicines represents millions of Canadians living with serious and debilitating illness whose common goal is to accelerate the pace of reform through partnerships and consumer involvement. "The federal government must stop trying to save money on the backs of seriously ill Canadians," added Kelly a breast cancer survivor and founder of the first breast cancer support group in Canada. "Sick people are getting sicker and the only barrier to better health is the backlog on the Health Canada loading dock." A summary of the proceedings including the Summit agenda, presentations and background information can be found at www.piscesonline.ca. -30- For further information: Media Contact: Jane Hamilton, See Jane Run Communications, Tel: (905) 337-2606, Cell: (905) 466-2070, e-mail: jane@seejanerun.ca Regards

To: Cal Gary who wrote (8547)	1/28/2002 2:36:05 PM
From: axial	Read Replies (3) \| Respond to of 14101

Hi Cal, everyone - Stimulating discussions today! "Until the results are published, investors can only use tools and indicators. Our DD is to place probabilities along that range. The more DMX releases about the WF10, ie intention to buy out OXO, the bulk of probabilities shift with new info towards the marginal to good range." The assumption here is that Rebecca and the BOD are making intelligent, rational decisions. If that premise is correct (let it be!), then the inference that WF10 looks good is also correct. As others have pointed out, there are some caveats with the Oxo purchase, and the acquisition has been built with escape hatches. Moreover, there are some associated signs that WF10 may not be the hot, hot product that we have speculated on; chief among these (IMO) is the lack of buying pressure. I (personally) do not believe that such a large P3 could have phenomenal results without some "leakage" - OTOH, it is a difficult P3, as pointed out. Again, by inference, my conclusion about the NASDAQ listing was based on an expectation of WF10 results. The premise is the same: that we are dealing with intelligent, rational management. Anyone who thinks that listing successfully on NASDAQ is possible, without stellar WF10 results, and a successful Pennsaid introduction, is mistaken. That said, I have found that management "teams" are often constitutionally incapable of assessing correctly the true future of their steps. The probability of that failing, IMO, is increased when leadership is more autocratic, and non-consensual. We have conflicting signs. The Acqua activity, however justified, masks some potential indicators. The Q2 results were a predictable non-event; we continue to put a finger to the wind, glance anxiously at the sky, and wait for news. Best regards. Jim

To: Cal Gary who wrote (8547)	1/28/2002 9:22:35 PM
From: DaveAu	Read Replies (4) \| Respond to of 14101

Cal/Joe, <<'ll have to go with Joe on this, they 'formally' announced July 18 to acquire OXO 'as soon as the blind was lifted'. The blind was originally expected June 2001, but confirmed to be early-mid July 2001.>> I appreciate all the info you two have provided on this board. I think you're two of the most valuable posters. I also think you've both picked up some serious mis-information about the WF10 phase 3. The study has not been un-blinded. Neither DMX or Oxo has ever indicated that it was unblinded yet. In the CC today, Rebecca stated something like "we need to verify all the data before the database can be locked". That's another way of saying that the blind has not yet been broken. And that is actually very good news. It puts to rest my AXO analogy - the reason for the delay is not that they're massaging the data trying to find sub-groups where the drug actually worked. It does raise a question however about the competency of the Oxo Chemie staff that were responsible for overseeing the trial. Will we be able to use all the patients that were enrolled or has some of the information not been properly maintained ? Back to waiting.. Dave