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To: axial who wrote (8440)	1/16/2002 9:13:07 PM
From: Tom Johnson	Respond to of 14101

Hi Jim: 1 -My experience with HC indicates this is very much a routine delay.In fact another biotech who had completed all the tests just ahead of us is still waiting as well. This was posted on SH by a longtime contributor who physically keeps an eye on our Varennes plant and reports activity from time to time. His name is "Luc" and I imagine Mark B. remembers who he is. 2 -HC rarely gets ahead of FDA in approvals. Last similar situation I can recall was QLT, also a Cdn. development and HC approval came about a year after FDA. 3 -Can't find any "weak spot"; been over the ground hundreds of times. JMHO - FWIW

To: axial who wrote (8440)	1/16/2002 9:23:53 PM
From: john.d	Respond to of 14101

Jim 'How much importance do the posters here attach to the theory that HC will not get ahead of FDA?' Although I think Becky thought otherwise, I do not believe that we will see HC unitl FDA gives the nod. It is as simple as that. They do not have the resources and are unwilling to take any risks until the FDA completes their evaluation. My own forescast is that we will see HC approval within one month of FDA granting approval. It's kinda sad really and begs the question of what role they really play. I guess politically they can't say that they wait for FDA. Real insight if you own a stock that is waiting on HC approval and has not even applied to the FDA, which I think I heard is the case for Hemosol- Not sure about that though. John

To: axial who wrote (8440)	1/17/2002 11:29:09 AM
From: Cal Gary	Read Replies (2) \| Respond to of 14101

Hi Jim, The MPs around this neck of the woods are all Canadian Alliance. LOL if they speak to Anne McLellan. For the majority, a barage of letter writing to your local Liberal MPs to Anne would help indoctrinate her showing the length of time HC is taking with Pennsaid, a Phase III, then IV, then another Phase III applicant. OA suffers (and Hockey/Lacross players too)need a safe and effective alternative to NSAID and COX II. 1. If the criteria was HC track record then this is a "run of the mill" delay. If the criteria was based on HC published rules and guidelines then "we are way overdue" for their response to the second Phase III application. So can't classify it as "unheard of". 2. HC's own track record can provide a math model that subjectively (I haven't put in the time to get the data)says high probability HC does not act before FDA. So HC, surprise us! Canadians are watching. LOL 3. Theory? ? Wild rumour and crazy speculation is HC insiders were shorting with the help of paid bashers. The've covered and loaded up the truck. Bashers no longer on the payroll, poof, pumkins. <G> LOL Disclaimer: fairy tales only, there's no evidence of this. Needed to say this to keep the slander police off my back. However, I believe this scenario happened with Biovail, but I maybe brain cell deficiant with age. The product is safe and effective according to published phase III reports. Normally, p values of < 0.5 gives stat good results. From faded memory, I believe Pennsaid scored p < 0.05, 0.03. So even smaller variation. Product is approved and accepted in 5 EU countries. The UK has its yellow and red card system to follow up new drugs. So far, no known card has been issued against Pennsaid. NICE report issued, red carded COX IIs. And of course, "Pennsaid Work, and Works Well!" "greatest potential "weak spot"?" Hmm? HC themselves. REK played by the book and got spanked. Over the long period of time from initial application til now, - Standards improved, - not allowed to add any new data to filings, - got approval to conduct large Phase IV non blind study, - when pressed, HC rejected application stating need for more data Aug 28 2000, - new Phase III conducted and submitted Oct 16 2000, - 300th day for a response from HC came and went - Allan Rock and his vision of POT using tax dollars. In a puff, HC funds! POT growing and distribution operations (illegal for anyone else to do in Canada/US) without the standard safety and efficy studies every other company spends 10 years of clinicals (Phase I,II,III) and $$$$ to conduct. Direct and indirect competition to DMX and others. In record time!! No rules or guidence to hinder. If only we'd had a Health minister in our side pocket. - REK "any day now" comment on, I believe, RobTV interview - Day 458th for HC response to the latest submission If Rock can make things happen with POT, let's see what Anne can do. Hope this helps. Have a great day.