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Biotech / Medical : Cardiogenesis (cgcp)

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To: Joy who wrote (11)7/30/1997 10:45:00 AM
From: John Martin   of 66
 
Keep reading the news releases for PLC. PLC is still a contender.

The FDA rejected PLC's application due to insufficient data. The FDA wants more information from the 12-month follow-up from the phase III trials. This information can be gathered in Sept. I would expect PLC to be applying for review again before the end of the year.

The results of the rejection is good for cgcp because they now know what the FDA wants and can be prepared for it. I would expect PLC will be fully prepared next time too.

John
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