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CUV, CLINUVEL PHARMACEUTICALS LIMITED
Billy Boots
post Posted: Today, 04:21 PM
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The ASX 200 drops 1.4% so CUV drops 7% any excuse of course not, if the CEO of this company got his act together sooner rather than later, we shareholders would by now have been in a great position. Too many mistakes over a LONG period of time. Bloody pathetic. How's my mate Dr Wally? graduated.gif


 
seeva222
post Posted: Today, 01:40 PM
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In Reply To: Dr Wally's post @ Today, 07:33 AM

He’s providing you real intel and his subjective opinion that’s useful, stop being a Wally.

 
seeva222
post Posted: Today, 01:22 PM
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In Reply To: Johnny H's post @ Today, 05:31 AM

Good find. If that’s completed and no Ad Comm, it’s just a matter of labeling and oversight (and Trump not killing the markets )

 
macgyver
post Posted: Today, 10:38 AM
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In Reply To: Dr Wally's post @ Today, 07:33 AM

You are an ungrateful person, especially considering we have to put up with your inane posts.

In other news, no announcement about the AdCom thus far. I’m giving it another day just to be safe, then I’ll consider it home and hosed (or at least it’s down to just CRL or glory).

 
blackm3
post Posted: Today, 09:02 AM
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In Reply To: Dr Wally's post @ Today, 07:33 AM

Sharemarket today for cuv not looking good .
Tuesday may be much worse unfortunately .

Trump vs china

 
Dr Wally
post Posted: Today, 07:33 AM
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Yeah right! 😑 Or your overly confident assumption could be completely wrong again, putting people that believe in you on a bum steer again like your 100% guaranteed RTF call did a while back.



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50+ on or before PDUFA... GLTA that have seen the future and kept the faith. 😎 Scenesse 100% will be approved. Too safe, too beneficial to the health of millions. Logic and community pressure will eventually prevail over regulator ignorance.
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Johnny H
post Posted: Today, 05:55 AM
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In Reply To: seeva222's post @ Yesterday, 10:50 PM

I'm 95% sure that the newsletters are templated, and the latest one was probably mostly written about 2-3 months ago with some minor changes. There are at least 4 giveaways in the FDA update.

Most of the "news" is not time specific, and could have been written anytime. Wolgen probably has a whole library of these to cut and paste.

"The nature of the discussions is collaborative and there is frequent exchange of information and clarifications on data submitted, for example on specifications and on the meaningful benefit against the side effect profile of SCENESSE®"

The FDA is doing FDA stuff.

"Ongoing interactions between the US Food and Drug Administration (FDA) and our scientific teams continue to take place as the final outcome date"

Stuff continues to happen as time progresses.

"All in all, our teams are working around the clock to ensure that this historic review comes to a positive conclusion. For now, the CLINUVEL teams are preparing documentation and internal processes for two possible outcomes."

People are doing the jobs they get paid to do.

"Central to all these processes remain people, those in our offices who have built and implemented the quality and pharmacovigilance systems for product distribution in the European Union. Most of these professionals are being involved in preparing for US market access in the near or distant future"

Employees are key to preparing for things that might occur sometime in the future.






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Clinuvel until my bowels release for the last time.

Said 'Thanks' for this post: sharelooker  San Diego  Farleap11  Clinhope  seeva222  
 
sharelooker
post Posted: Today, 05:51 AM
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In Reply To: rabbitrun's post @ Today, 05:41 AM

Hopefully the FDA announce the final PDUFA outome right after the labelling communication on September 6. That would be great!


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rabbitrun
post Posted: Today, 05:41 AM
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In Reply To: Johnny H's post @ Today, 05:31 AM

Not much left on the to-do list.

By the way - Oct. 6 falls on a Sunday. So maybe we hear Friday (ha ha) or the following Monday, 10/7?


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Johnny H
post Posted: Today, 05:31 AM
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The outstanding "Q&A Clinical use post-MA" that was originally scheduled for May and delayed for 2 months was apparently completed some time between the July 11th newsletter and August 20th newsletter.
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Clinuvel until my bowels release for the last time.

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