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Gold/Mining/Energy : Nuvo Research Inc -- Ignore unavailable to you. Want to Upgrade?


To: Cal Gary who wrote (14077)12/30/2006 1:13:46 AM
From: twentyfirstcenturyfox  Respond to of 14101
 
Hi Cal: Happy New Year to all. Shockhouse seems to be where all the chatters are. Pity, as it is hard to slog thru 50 posts to find one from Rob et al.
shewhomustbeobeyed says: Americans, mostly, just cannot accept something which is not invented by Americans - they have an innate distrust of all things 'foreign' and lets admit it - Canada is foreign to many, (excepting my dear American friends!). Consequently, she believes that FDA will string along this approval process, until either (a) Nuvo is Americanized or (b) a competing American product comes to the FDA for approval. In a roundabout way: ask; why should some supervisor at the FDA stick their neck out for a piddly little Canuck drug? Any facts to support either hypothesis? Yes. One, surely? FDA has been stringing us along. Pennsaid is an innovative and effective drug therapy, in use hundreds of thousands of times in other countries, for the past 12-18 months. Is it not reasonable to presume that the FDA could should have called the company for a meeting to resolve their concerns, before issuing this letter? Is a buyout at a Canuck buck not likely? I could not catch the CC (or was it just a NR?). We have super slow service here in SE Asia as a consequence of recent damage to underseas communications cables. Was any mention made of progress with a US distributor? Surely there would have been some genuine, tangible wheeling and dealing, with a subject to approval clause, that could be reported on as 'talks are in an advanced stage, blah blah'...by now? Fox.



To: Cal Gary who wrote (14077)1/8/2007 6:17:04 AM
From: Mark Bartlett  Respond to of 14101
 
Cal Gary,

It is my understanding that issues with "approvable" letters are usually quite minor -- certainly no more studies would be required.