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CUV, CLINUVEL PHARMACEUTICALS LIMITED
Johnny H
post Posted: Oct 11 2019, 02:03 AM
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I was glad to see that Kendall Marcus signed the approval letter, even though she wasn't required to.

She looked the EPP patients in the eyes and listened to what they were saying.



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Clinuvel until my bowels release for the last time.

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nisperoy
post Posted: Oct 11 2019, 01:57 AM
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In Reply To: MinusSinus's post @ Oct 10 2019, 08:34 PM

"
http://www.more-ir.de/d/19163.pdf

Following the strong outperformance of the shares since initiation of our research coverage in January 2018 (+343.9% vs. ASX 200 +6,2% and DAX -8.4%), we confirm our buy rating for the Clinuvel shares with a base-ca Monte Carlo simulation, we calculate bear and bull case scenario equity values of AUD 113.60 and AUD 33.10 per sharease scenario equity value of AUD 58.40 per share."

In a Monte Carlo simulation, we calculate bear and bull case scenario equity values of AUD 33.10 and AUD 113.60 per share, respectively.


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investek
post Posted: Oct 11 2019, 01:17 AM
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Evolution of the Thorough QT/QTc study
https://www.celerion.com/wp-content/uploads...T-QTc_study.pdf
QUOTE
Some drugs with multiple potential indications are submitted to different divisions within the FDA. There was initially little uniformity between divisions in their approach as to whether a TQT was needed or how it would be designed. The FDA assembled an Interdisciplinary Review Team (IRT) with members from project management, medical, statistics, and pharmacology from across several divisions in 2006.20 The IRT has been successful in providing more uniformity in QT evaluation across these divisions. The IRT should review all TQT study designs to make sure they are complying with E14, especially if the study is not the “classic” design outlined above. In order to evaluate the study design, the IRT requests a significant amount of data about the compound. They developed a document, the Clinical Highlights of Pharmacology,21 to collect all that information in one place. Inadequate characterisation of a compound’s pharmacology has resulted in delayed IRT reviews in the past. The IRT is advisory to the review divisions and those divisions still make the ultimate decision about TQT assessment, though they do tend to follow the IRT recommendations closely.
The IRT has reviewed more than 170 TQT study reports. As mentioned above, it has intermittently shared information gathered from those exercises at meetings and in the literature. For example, the FDA recently revealed that eight TQT studies had an inadequate moxifloxacin response, making the studies uninterpretable. Seven of these studies were parallel design. The FDA has advocated that parallel studies have a combined placebo/moxifloxacin arm (nested) rather than two separate arms. This allows a closer temporal assessment of moxifloxacin and study drug QT effects, which may decrease the moxifloxacin failures in parallel studies. 22


One possibility I can think of is that Wolgen has shared more details than we realise with the FDA, potentially several future indications, other skin conditions eg psoriasis, neuro eg MS, gut? occular? Cardiac? (Deficiency in Melanocortin 1 Receptor Signaling Predisposes to Vascular Endothelial Dysfunction and Increased Arterial Stiffness in Mice and Humans), perhaps one of these other potential applications or something flagged by the IRT prompted the need for the review?

https://www.ahajournals.org/doi/10.1161/ATVBAHA.114.305064

And this too...could be pretty standard for ‘new’ drugs...
QUOTE
The QT interval occupies a pivotal role in drug development as a surface biomarker of ventricular repolarization. The electrophysiologic substrate for QT prolongation coupled with reports of non-cardiac drugs producing lethal arrhythmias captured worldwide attention from government regulators eventuating in a series of guidance documents that require virtually all new chemical compounds to undergo rigorous preclinical and clinical testing to profile their QT liability.

QT Assessment in Early Drug Development: The Long and the Short of It
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6471571/


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investek
post Posted: Oct 11 2019, 12:39 AM
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In Reply To: Johnny H's post @ Oct 11 2019, 12:33 AM

Not way ahead of you, just a couple of clicks, unfortunately I can’t speak to this with any knowledge/authority (need to keep digging).
Maybe something to do with the fact it is systemic/long term/slow release drug?

I echo scipio79, the language ‘administrative only’ sounds positive!
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Johnny H
post Posted: Oct 11 2019, 12:33 AM
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In Reply To: investek's post @ Oct 11 2019, 12:17 AM

Since you're already way ahead of me on this...

Is this routine, and happens to a lot of NMEs? Or is there something that would have triggered it?



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Clinuvel until my bowels release for the last time.
 
scipio79
post Posted: Oct 11 2019, 12:21 AM
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In Reply To: Texas T's post @ Oct 11 2019, 12:06 AM

I disagree. The EMA placed restrictions on distribution of the product. The FDA placed no such restriction. It merely ordered a study of cardiac repolarization which only lasts 10 months. The longitudinal study is required for a decade, but only requires reporting of adverse events. This is a mere administrative requirement that can be easily and cheaply done. As a brand new molecule, these requirements are not draconian, but prudent and will establish, hopefully, the long term safety of the drug. The timelines were suggested by Clinuvel. I still see no barrier to US doctors prescribing this drug as they see fit. The only barrier to that is Clinuvel itself.


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investek
post Posted: Oct 11 2019, 12:17 AM
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In Reply To: Johnny H's post @ Oct 11 2019, 12:12 AM

Guidance for Industry
E14 Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs
https://www.fda.gov/media/71372/download


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LevelHeaded2000
post Posted: Oct 11 2019, 12:14 AM
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In Reply To: Texas T's post @ Oct 11 2019, 12:06 AM

Not really anything unusual. Look at any drug and there is post marketing work. Heck, look at the recently approved Vyleesi: https://www.accessdata.fda.gov/drugsatfda_d...rig1s000ltr.pdf


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Johnny H
post Posted: Oct 11 2019, 12:12 AM
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In Reply To: Texas T's post @ Oct 11 2019, 12:06 AM

Yeah, I was surprised to see that they required a cardiac repolarization study. I've never heard of that being a concern before.



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Clinuvel until my bowels release for the last time.

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Texas T
post Posted: Oct 11 2019, 12:06 AM
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In Reply To: xlnja's post @ Oct 10 2019, 11:38 PM

Lots of post-marketing requirements in the Approval Letter, and some of the studies must be conducted until 2031. Seems more onerous than the EMA requirements.





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