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CUV, CLINUVEL PHARMACEUTICALS LIMITED
LJS
post Posted: Jun 23 2018, 07:27 PM
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In Reply To: Johnny H's post @ Jun 23 2018, 04:53 PM

Agree, the NDA 'promised' before July1, that triggers share issue to PW, so I'm thinking the latter might be the halt reason but we'll see. Should be some interesting releases to follow re complimentary products , sales in Europe et al. GLTA


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ignoramus
post Posted: Jun 23 2018, 07:21 PM
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In Reply To: mrdax's post @ Jun 23 2018, 06:49 PM

The Germans told the world for years that VW and Audi motor vehicles met the emission standards. Some people lie, some people make honest mistakes. I’m not yet convinced that everything Clinuvel tells the market or the regulators is the real facts. It’s a sloppy company that cannot even write a clear email to the regulators so there is little reason to believe their very selective story about what is happening in the EU. Goodnight.

 
xray
post Posted: Jun 23 2018, 07:01 PM
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In Reply To: xray's post @ Jun 23 2018, 07:00 PM

Sorry...
Posted under the wrong alias earlier.


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xray
post Posted: Jun 23 2018, 07:00 PM
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In Reply To: ignoramus's post @ Jun 23 2018, 06:40 PM

I take your point ‘mrdax', you are correct. Clinuvel used the word submission in the email REQUEST FOR TRADING HALT. The word submission is not used in the ASX announcement.

Still begs the question why does it take two trading days to make a simple announcement presumable about a regulatory submission.

Darren Keamy (Clinuvel CFO) is prone to making errors.

My post about a possible adverse drug outcome would also be incorrect. I too am prone to making errors.

 
mrdax
post Posted: Jun 23 2018, 06:49 PM
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In Reply To: ignoramus's post @ Jun 23 2018, 06:40 PM

QUOTE
Still begs the question why does it take two trading days to make simple announcement presumable about a regulatory submission.

I guess this is the core question we're all wondering about since 1.5 days, 'ignoramus'. Why instead of build the worst type of speculation without any indication, why not just wait for 2 more days?


If there were any bad news, why not just release it? Were any previous news announced only after a TH?

If NDA-submission is further delayed, why not just announce it, as it was done mid/end of mai already? We didnt see any TH there neither.

If NDA-submission is completed, why do a TH; as the market expects it anyway.

If FDA approved and/or rejected the NDA, we should all be wondering about why the NDA-submission was delayed 5 weeks ago. Even if it is on rolling basis, I don't see how the FDA could reject/approve an non-submitted NDA.

EMA withdrawing permissions for scenesse? Why should they, after 12 years of safety profiling and the latest announced safety-profiles in March or April this year, where it was just confirmed that 99% of people want to continue the treatment with scenesse?


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ignoramus
post Posted: Jun 23 2018, 06:40 PM
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In Reply To: mrdax's post @ Jun 23 2018, 05:57 PM

I take your point ‘mrdax', you are correct. Clinuvel used the word submission in the email REQUEST FOR TRADING HALT. The word submission is not used in the ASX announcement.

Still begs the question why does it take two trading days to make a simple announcement presumable about a regulatory submission.

Darren Keamy (Clinuvel CFO) is prone to making errors.

My post about a possible adverse drug outcome would also be incorrect. I too am prone to making errors.

 


macgyver
post Posted: Jun 23 2018, 06:19 PM
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In Reply To: mrdax's post @ Jun 23 2018, 05:57 PM

Maybe it wasn’t poor trolling after all. Sorry Iggy.

 
mrdax
post Posted: Jun 23 2018, 05:57 PM
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In Reply To: ignoramus's post @ Jun 23 2018, 02:30 PM

QUOTE
For instance what would be the reaction if an EPP patient in Germany being treated with Scenesse was diagnosed with a melanoma or a brain tumour? A two day trading halt may be required for the professionals to ascertain if there is any connection to the prescribed drug

Wouldn't they write "announcement w.r.t. regulatory permission/license" instead of "announcement w.r.t. regulatory submission"?

 
investek
post Posted: Jun 23 2018, 05:07 PM
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In Reply To: FarmaZutical's post @ Jun 23 2018, 04:07 PM

I was thinking something similar regarding World Vitiligo Day on Monday.

Perhaps the trading halt/market sensitive announcement with encompass not only a confirmation of the NDA submission for SCENESSE in EPP but also details of an agreed upcoming Phase 3 trial for a second indication Vitiligo?

See below extract from a prior (Aug 2016) CUV release that mentions the next steps re:Vitiligo.

QUOTE
FDA REQUIREMENT
CLINUVEL has completed one US Phase II clinical trial of SCENESSE® in vitiligo patients (CUV102), with a second study (CUV103) underway in Singapore. In both studies the drug has been used in combination with NB-UVB light to evaluate its safety profile and ability to repigment skin in vitiligo patients.

The results of CUV102 and preliminary results in CUV103 show that SCENESSE® in combination with NB-UVB light administered twice or thrice weekly had a good safety profile, and the optimal effectiveness of the combination was identified in patients of darker skin complexion (Fitzpatrick skin types IV, V and VI).1

The FDA communicated to CLINUVEL that – prior to pursuing later stage clinical trials and seeking marketing authorisation for SCENESSE® in vitiligo in the US – the company would need to demonstrate the safety of the drug in combination with NB-UVB light, simulating the proposed human dose regimen in a pre-clinical model.

Now that the requirement has been completed, CLINUVEL will request a guidance meeting (Type C) with the FDA to discuss the next clinical trial in vitiligo patients in North America.


http://clinuvel.com/investors/news/item/49...ination-therapy


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ignoramus
post Posted: Jun 23 2018, 05:02 PM
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So based on Frogster’s scenario Clinuvel could make and an announcement prior to the ASX commencing trading this coming Monday. There would be no need for the trading halt to continue throughout the entire day. It’s getting very crazy.

Have I improved any Macgyver?


 
 


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