Dave,
We don't seem to be able to catch a break yet.
Here's an article by a poster on Stockhouse that you may
have read - DI7026, whom I find very knowledgeable
which I found nicely summarizes the situation.
Wolf
Yes, with this Mutual agreement deal, all countries included on the final list have to approve Pennsaid. But it doesn't have to mean all 13 countries originally applied to. For example, if only 11 countries are on side and 2 not, DMX can choose to include only the 11 countries in the Mutual agreement pack, and drop the other 2. Then DMX if it chooses so, may apply for marketing in these 2 remaining countries via other routes (not the Mutual agreement route).
You are right that the 4 countries that are on side now have not officially granted approvals, but rather they are now on the on-side list awaiting the remaining 9 to come up with their decisions. However, DMX may now start working with these 4 countries on the final labelling for Pennsaid. (As a highly unlikely example, tomorrow DMX may decide to go ahead with only the 4 countries and drop the remaining 9. Then DMX will proceed to finalize the labelling with only these 4 countries and start selling Pennsaid in these 4 countries as soon as the labellings are done.)
The remaining 9 countries seem to be taking their good old
time as you might expect in government bureaucracy since there are really no consequences to their not adherring to the time line. I think the EU eventually needs to have one central agency for drug approval to avoid this problem. |
