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Biotech / Medical : Transkaryotic(tktx)

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To: tuck who wrote (112)1/6/2003 12:33:55 PM
From: keokalani'nui  Read Replies (1) of 122
 
On the market in the EC, TKTX's Fabry drug is in deep trouble in the US regulatory process. A politically senstitive fda would do just about anything to approve both genz' and tktx's drugs concurrently by three-way agreement. By agreeing to look at endpoints other than the previously agreed pain EP, the fda sure seems to be going beyond the call of duty to help tktx out.

The IP under its lead epogen me-too drug was creamed by amgn in the US, but could be reinstated by an appeals court; where frankly it probably has a better chance than in the trial court. Had a better IP result in the EC, but not being sold there pending US IP issues--glaxo would have to manufacture it over there.

IS2 (Hunter's candidate) is coming, but small population group. Morquia is preclinical. FVIII gene therapy looks like failure. Has 2 partially disclosed programs, one enzyme replacement in Gaucher's pointed straight at Genezyme and another epogen-like manufactured protein named GAII (P1 completed). Cash, but burning it up at a frighteningly swift rate.

There is also (to me) an unclear overhang of unissued shares
owed in connection with a 2002 IP settlement.

This is one to approach very very cautiously if at all. I only added it to my contest entry (the smallest amount) because from these levels it has the potential to surprise in next 12-months.
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