World Heart Corp - WHRT and TSE/WHT Message Board

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Biotech / Medical : World Heart Corp - WHRT and TSE/WHT

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To: Dan Hamilton who wrote (424)	4/26/2000 4:26:00 PM
From: William Marsh	Read Replies (1) of 500

Yes, exactly. These are the tests which will occur over the 2nd and 3rd qrt, which are on schedule. 6 months for testing, 45 days for approval - this still leaves them 45 days for initial human implant this year. The production capacity is sufficient to support the tests. The battery component manufacturing lags the other production a bit but this was anticipated and will not delay testing. Recent reorgs at Health Canada does not effect medical devices section. Health Canada is being kept fully informed. Some old news repeated: They will apply for approval in Canada, then Europe and South America, then US. A bit of new news (new to me anyway): they think that approaching US regulators with clinical data from Canada and US will assist approval in the US. (This makes sense, of course, but wasn't a given, considering we are dealing with the Yanks.) Bill

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