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CUV - CLINUVEL PHARMACEUTICALS LIMITED


colaiscute

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What puzzles me most is the decisions the company will take after approval and other events:

 

What are they going to focus on besides eu commercialisation?

Will they achieve eu wide reimbursement?

How much money will come back from ema for orphan an sme status?

Will us epp results b strong enough to continue?

Will fda fast track approval?

Will final us vitiligo results warrant phase 2b?

Will 10% capital increase be enough or will cuv find a development and commercialisation partner?

What will be the next shape of scenesse, a cream or a nasal spray?

What about cuv9900 development steps?

Are they also going to sell vacuum cleaners?

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Not that it provides any consolation but a quick check of meeting minutes and agendas from the COMP site shows Scenesse is not alone in a long wait. Of the 21 drugs listed in the April agenda for "On-going procedures" there are 6 including Scenesse that have been holding in that category since at least July 2012. The others are 5.3.3 Cholic Acid FGK; 5.3.5 Cysteamine bitartrate; 5.3.14 PAS-GR; 5.3.15 Pomalidomide Celgene; and 5.3.16 Revlimid.

 

No doubt their investors are frustrated as well.

 

Cash drain is going to become a pressing issue very soon. Even with an approval in the next few months reimbursements are sure to lag behind. Expect either some additional share dilution or a partnership agreement for vitiligo coming by the end of summer. In both cases the company will want an approval first to help jack up the share price and company value.

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On pricing and approval of drugs in the UK (Nature News interview with Michael Rawlins (chairman of the National Institute of Health & Clinical Excellence):

 

"We normally say anything [such as a drug costing] less than ÃÆâ€â„¢ÃƒÆ’ƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚£20,000 (US$30,000) per QALY should be a yes unless there are other factors. Above ÃÆâ€â„¢ÃƒÆ’ƒÂ¢Ãƒ¢Ã¢Ã¢â€š¬Ã…¡Ãƒâ€šÃ‚¬ÃƒÆ’…¡ÃƒÆ’â€Å¡Ãƒƒâہ¡ÃƒÆ’‚£30,000, there should be increasing reluctance to say yes except under special circumstances. The third component, which is I think the trickiest one, is what the economists call the economic perspective. We look at the costs and savings to the health service. You could take into account the costs for carers and families, or implications for employment. The government has indicated that it does want a more societal perspective."

 

http://www.nature.com/news/assessing-the-v...d=NEWS-20130402

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Well if the regulators didn't drag things out to the n-th degree and make the drug approval process such an expensive bureaucratic nightmare, then the drugs wouldn't be so expensive. I'm fully aware of the intent to derail unsafe products, but on one end of the scale people are dying [ironically] waiting for life saving treatments in the name of safety ! Furthermore, if not for medical insurance (which I truly believe is in collusion in the whole mess), they couldn't afford the treatments even when approved !

 

... and meanwhile I'm dying of impatience in this matter.

 

 

 

 

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Uho has been digging in prac comm agenda correlation with nxt month chmp and found that there is big chance cuv is up for April opinion chmp regardless of comp agenda.

Only depending on outcome of prac discussion for opinion to chmp, if more queries about risk plan all is deferred. That 5.1.1. discussion took place long before March chmp meeting.

 

But unlikely it will be deferred. Scenesse has orphan drug designation, cuv is sme and they get so much assistance from rapporteurs, or is it rappators as axeldeskruf calls them, that a reject would be due to lack of diligence from company. With this expensive, prescribed implanted drug off label is unlikely if not impossible but driving non epp people towards unregulated and widely available cheap injectable copies from china or india. Still waiting for ema/eu geniuses to do something about that.

 

We all wittnessed the minutious approach of cuv to epp maa and from last newsletters ceo talk we know ema was highly concerned about cuv mitigation of off label use...to be answerred in risk mitigation plan. Ceo also stated that it was now just waiting for ema to release this drug to epp community. A-typical confident statement.

 

All lights green, only Malta can stop us now.

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