Have you read the latest report by ABN.A? Here is an extract of one of the risks they flag:
Next steps – synthetic heparin on track for market launch in 1HCY10
Depending on review time at the FDA, ACL anticipates market launch by end-2009. This
assumption is based on the FDA's Generic Initiative for Value and Efficiency (GIVE) program
announced in 2007, under which the FDA prioritises the review of first generics (like ACL's
fondaparinux), aiming to complete the review within six months of filing. Given anecdotal
reports that the FDA is not meeting targeted approval timeframes, we will be closely
monitoring this milestone and would not be surprised if there was a little slippage here. If
ACL is not eligible for priority review, the average review time for ANDA submissions is 15-18
months. We model first sales occurring from 1HCY10.
For an insight into what is happening globally - India - have a look at this. I obviously cant send you my reports so I can only post the links that I have. We all need to balance the knowledge that a CEO can give us vs. the knowledge and experience of analyst firms. One will tend to be co. specific and micro focussed. The other will look at all risks and weigh the macro and micro factors to formulate an opinion (page 18 is quite interesting):
http://www.moneycontrol.com/news_html_files/news_attachment/2009/tfp20090610.pdf
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