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To: DaveAu who wrote (7759)10/2/2001 9:00:28 PM
From: Montana Wildhack  Read Replies (2) | Respond to of 14101
 
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.



To: DaveAu who wrote (7759)10/3/2001 12:10:55 AM
From: jef saunders  Respond to of 14101
 
in the last conference call, Rebecca gave november as the time line for the 13 countries to respond, not october. so these 4 countries are early birds, not the only ones to show up to the party. i view as exciting, not a disaster. as one of my friends was comparing dimethaid to the rest of the market , "A ray of hope in an otherwise dismal environment. "

i too thought the "over the boarder" statement was a little wierd. but i wasn't thinking in terms of germany and france, where i expect approval by next month. i think more in terms of afghanistan , as we shoot holes in the knees of the taliban, those guys are going to need lots of pennsaid. their camels too.



To: DaveAu who wrote (7759)10/7/2001 2:00:38 AM
From: Cal Gary  Respond to of 14101
 
Hi Bluejay, how about that Bonds dude, 70, 71, 72...

I did some verification of what SH's Betthefarm and some others discussion around Vioxx and Celebrex at
heads.medagencies.org.

I can understand why the two opposing arguements looking initially at the query for Vioxx and celecoxib. I interpret that Merck and Pharmacia got 14 countries on side in the 90 day process. No wonder they also captured $5 BILLION revenue between the two in one year. Like the lottery. People responded to the then safer alternative.

NICE of course changed all that. Its even ironic that Celebrex in some countries are called Celora,
Aclarix, Solexa, and the better sounding Celebra. After NICE, some guy ought to be in a Cell because of cele-BREX style data fuggin.

Thinking outta the box, ie just guessing, NICE may have also bit DMX in the butt too as regulators realized their mistake with VIOXX and Celebrex, the safer alternatives. Along comes DMX with Pennsaid as the safest of all alternatives. I bet there was some skeptism and in the end we get only 4 countries on side.

But we'll never know....