Global Stem Cell and Regenerative Medicine Index Print E-mail
Wednesday, 04 February 2009 04:18
The ETF Innovators Global Stem Cell and Regenerative Medicine Index includes 40 companies with market caps less than $1B at the index inception and the total market value of the index will be tracked as a gauge of investor and trader sentiment toward stem cell companies from a starting value of 3,928 on 2/22/09 and current value of 3,860 as of 2/25/09 - down 1.7% from the closing value last week.
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Caraco Pharma Awaits FDA Inspection in May Print E-mail
Wednesday, 04 February 2009 04:11
I spoke with the investor relations representative for Caraco Pharma (CPD) earlier this week and received some clarity on the expected timeline for resolving the major overhang on the stock price related to the FDA warning letter over Form 483 concerns by the agency stemming from quality control issues raised during an inspection of manufacturing facilities last year.   Caraco has responded in full to the warning letter and the FDA will evaluate the corrective actions taken by the Company at its next scheduled inspection, which is expected to occur some time in May. Caraco believes it is compliant with the FDA's cGMP regulations related to manufacturing and quality control and the issue remains the top focus at the Company, reflected by investments in personnel and facility upgrades.   The Company expects the FDA inspection in May to be the final step in resolving the warning letter issues as the agency will evaluate Caraco's upgrades in manufacturing and quality control at the Detroit facility to determine if these actions satisfy the agency's Form 483 concerns.
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