Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: Henry Niman who wrote (26009)	10/6/1998 9:08:00 AM
From: growthvalue	Read Replies (1) \| Respond to of 32384

The trend of the large pharmas is definitely toward simultaneous filing - at least in the US and Europe, which is where drug companies get a vast majority of their sales. Celeryroot is correct about Europe - there is a "mutual recognition" agreement among a large group of European countries where one country actually performs the regulatory review and other countries agree to recognize that approval within their own country. It is also the case, however, that price and reimbursement must be negotiated in each individual country. This can get some companies into trouble if they get different prices from country to country b/c it leads to "parallel imports" where the drug is imported from countries with lower prices into countries with higher prices. Finally, the EU does not have a specific policy for priority review the way the US does. So simultaneous filings definitely don't mean simultaneous approvals. It tends to take about 12 months in Europe, whether or not the product gets a priority review from the FDA, in which case the FDA is required to make a decision within 6 months of the filing of the NDA. GV