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CUV, CLINUVEL PHARMACEUTICALS LIMITED
seeva222
post Posted: Sep 19 2019, 08:36 AM
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In Reply To: rabbitrun's post @ Sep 19 2019, 08:24 AM

"Mgmt has struggled launching in EU (co by co pricing) & filing w/ FDA, docs very + on drug. 10/6 will be interesting!"

I agree with CUVs pricing strategy, btw. I think it will pay off.

 
rabbitrun
post Posted: Sep 19 2019, 08:24 AM
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In Reply To: Johnny H's post @ Sep 19 2019, 06:47 AM

I think we all can guess, but does he get into specifically which business decisions?

 
Johnny H
post Posted: Sep 19 2019, 06:47 AM
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In Reply To: sharelooker's post @ Sep 18 2019, 05:47 AM

QUOTE
Does anybody have access to Slingshot Insides?

https://twitter.com/JMac_SI/status/1173993866392932352


Long story short:
-The French doc has been treating EPP for 30+ years, and was one of the researchers who discovered the genetic defect.

-He's retired now, which is why he decided to speak on the record.

-He's seen the new data, and declined to discuss it until it's in the public domain (did not specify if it was because of non-disclosure or if he was doing so of his own volition)

-He firmly believes that the FDA will approve

-He would have designed the clinical trials differently, namely, using prodromes as an endpoint instead of a painful reaction

-He has administered 3 separate arms of Scenesse clinical trials since 2006

-He's friends with Wolgen

-He's not impressed with Clinuvel's business decisions thus far generally, and specifically, in his home country of France.

That's about it unless. If anything else comes to mind, I'll update.



--------------------
Clinuvel until my bowels release for the last time.
 
Justinian
post Posted: Sep 19 2019, 04:39 AM
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In Reply To: Texas T's post @ Sep 19 2019, 02:08 AM

Their response to that would probably be to suck it up and go live in a cave, they don’t need the medicine anyway.

 
Texas T
post Posted: Sep 19 2019, 02:08 AM
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In Reply To: Johnny H's post @ Sep 19 2019, 01:20 AM

Well, the ethics committee didn't think it through. The alternative that was followed was to rely on the subjects to voluntarily burn themselves outside on their own during the phase 3 period. Many of them were understandably not willing to do so, and many taking Scenesse weren't willing to go in the sun either. Under the clinical testing, the subjects wouldn't be severely burned. They would stop once there was a reaction and would never have to continue testing beyond that first reaction. Oh well, it's all water under the bridge now. The real word data has rectified the unreliable phase 3 data. But never underestimate the power of NICE and other regulators to fixate on the old phase 3 data and ignore all of the more recent and relevant data.


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sharelooker
post Posted: Sep 19 2019, 02:03 AM
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https://twitter.com/JMac_SI/status/1174348744889909253


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Johnny H
post Posted: Sep 19 2019, 01:20 AM
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In Reply To: Texas T's post @ Sep 19 2019, 12:37 AM

The ethics committee rejected that model outright on the grounds that it was inhumane.



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Clinuvel until my bowels release for the last time.
 
sharelooker
post Posted: Sep 19 2019, 01:09 AM
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In Reply To: odi01's post @ Sep 18 2019, 11:18 PM

Thanks odi01! This made my day! Hopefully, they'll publish the new data in a reputable journal like NEJM or Lancet! Also expecting an asx announcement about it because it is highly relevant!


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NewToCli
post Posted: Sep 19 2019, 01:03 AM
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In Reply To: Texas T's post @ Sep 19 2019, 12:37 AM

Well because you cannot force the placebo group to burn themselves off by the lamp ...


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NewToCli
post Posted: Sep 19 2019, 01:02 AM
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In Reply To: IntiRaymi's post @ Sep 19 2019, 12:04 AM

Cuv mentioned they added the real world data packages to the Nda.. so the fda should have all the additional data and benefits of SC. Just hope that the other eu countries will stop the bullshitting now and just accept the life ch aging medicine !!!!

 
 


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