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Biotech / Medical : DECODE GENETICS-*DCGN
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To: kenhott who wrote (253)10/6/2006 12:38:44 PM
From: keokalani'nui  Read Replies (2) of 313
 
1. Old mfg process used for P2.

2. Old mfg process could not scale-up for large multi-year trial.

3. Some changes made, dcgn not sure exactly what went wrong or who at fault—but it is not the API. Dissolution, PK, bioavail all looked good and comparable to P2 cpd before embarking P3. Routine check uncovered dissolution issue do to length of time drug is stored. No doubt about whether it is an issue, it is.

4. Not exactly sure how to fix it, several ideas already.

5. Several months delay, at least. May have to redo PK, depends on changes. All this not clear.

6. No P3 data will be useful. No idea yet on financial effect. Future interesting strategic issue will be relative commitment to x051 vs x031 by the time x031 is ready to go back into clinic.
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