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To: Joe Krupa who wrote (10602)8/18/2002 12:13:22 PM
From: axial  Respond to of 14101
 
Joe, fantastic. A fine piece of work.

The potential in DMX (as revealed by research, not posting blather) is real. It is, as yet, unrealized. But there are good, sound reasons for optimism - not only on Pennsaid, but also WF10.

Based on what we know - mistakes, missteps, wonderful achievements, and enormous potential - DMX is a fine investment.

Right now, the immediate future of DMX is in the hands of regulatory agencies.

So, we wait.

Thanks,

Jim



To: Joe Krupa who wrote (10602)8/18/2002 12:57:42 PM
From: Ron Nairn  Read Replies (1) | Respond to of 14101
 
An excellent presentation Joe. One small typo that I did notice was RK's last quote. You stated July 11/01. "We expect to hear from the FDA in August". I think your reference s/b "02". And there are only 10 working days left in August. I also reference RK's response in the CC that discussions with the FDA are so close that she deferred any comment at that time. I personally expect a PR next week but the following week would still meet her timelines.

Rondo



To: Joe Krupa who wrote (10602)8/18/2002 7:34:24 PM
From: Cal Gary  Read Replies (1) | Respond to of 14101
 
NICE Work Joe!

Thanks for sharing the DMX/FDA review timeline.

Interesting, according to your chart FDA cumulative time is about 32 or 33 months.

You placed "FDA Review Hiatus" starting in Jan 2000 and ending a year and a half later. During this time, DMX started 2000 at around $4.25 and hit the $14+ mark.

Pictures do reveal much more than words.

Much thanks!!

PS Any way to superimpose the price chart over your gantt chart?? Sorry I'm just being pig headed. oink oink.

PS 2= My how time flys. Cheers. Anniversary of:

"We are very confident we will have approval from the FDA... I can say with great confidence and great comfort that Pennsaid will be the first topical NSAID approved in the US for the treatment of arthritis." Rebecca Keeler Aug 17, 2001



To: Joe Krupa who wrote (10602)8/18/2002 9:53:46 PM
From: john.d  Read Replies (2) | Respond to of 14101
 
Hi Joe thanks for taking the time to prepare the chart; it provides a nice snapshot of all the key issues. I personally wonder if there should be another line for the second phase III trial that was completed during this period?

In any event, enough is enough and your chart clearly points out that we should receive an answer from the FDA one way or the other soon. Everyone is expecting the answer in August (so am I) but I would not be totally shocked if we didn't see anything until September or even as late as October (dissappointed yes). Sometimes things take longer than we all expect.

Hoping that we receive a positive answer soon.

John