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post Posted: Today, 04:50 AM
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In Reply To: mrdax's post @ Today, 01:37 AM

I believe they did the same last year, it is in the days leading up to rare disease day.

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post Posted: Today, 03:57 AM
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In Reply To: Dr Wally's post @ Yesterday, 07:06 PM

Obviously. First it was the FDA doing everything to stop it. Now they are doing everything to get the drug to patients. It’s a love/hate affair with them.... wub.gif grrr.gif

post Posted: Today, 01:37 AM
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Lately, CUV is posting about some rare skin diseases...
Have those been seen before on the CUV and/or FB page?

Actinic Prurigo (AP)

Urticaria Pigmentosa (UP)

And lastly, Hydroa vacciniforme (HV), this post on FB:
"Hydroa vacciniforme (HV) is a rare, chronic photosensitivity disorder commonly occurring in children. The disease is characterised by the eruption of inflamed bumps and fluid-filled blisters (vesicles) on the skin following exposure to sunlight. Commonly presenting on the face, ears and hands, these vesicles heal over time as pox-like or “vacciniform” scars. Ultraviolet A (UVA) radiation (320-400nm) is the main wavelength of light which has been demonstrated to induce symptoms."
Which, unprofessional as they are, links to which basically is a dead link (at least for me).

Are those listings just for the sake of completeness to build awareness of rare skin diseases...?
Or is any of those a future target for the "photoprotective company"

Said 'Thanks' for this post: Justinian  
post Posted: Yesterday, 10:49 PM
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The HAS is officially evaluating Scenesse :
French EPP patients can give their opinions until April 2.

HAS Twitter

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Dr Wally
post Posted: Yesterday, 07:06 PM
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In Reply To: endymion96's post @ Yesterday, 04:13 PM

“”At the start of the year and with the “EPP season” nearing in the Northern hemisphere, our teams find themselves in the midst of preparing for all mandatory European activities, while the US discussions with payors and intermediaries are progressing to facilitate access to SCENESSE® (afamelanotide 16mg).1

Simultaneously, the FDA is reviewing the obligatory post-marketing protocol to ensure CLINUVEL will remain in compliance with its requirement to monitor American EPP patients for the duration of a minimum of eight years (up to 2027).

As stated during the investor call on 9 October 2019, US distribution will be staged and depending on logistics, training & accreditation,*** final post-marketing
authorization protocol signed off by the FDA before we will see patients on treatment.”” ***

My basic understanding is that “payors” are obligated to cover drugs that have been FDA approved so “payors” shouldn’t be the cause of further brain numbing delays??

As for the FDAs “final post-marketing authorization protocol” designed specifically for Scenesse roll out?? because of the potential for photo protective tanning abuse, God only knows how draconian and convoluted and time consuming that could end up being.

I’m sure though the FDA (seeings in 2019 they approved Scenesse) wouldn’t want to be the only reason why US EPP community are stillunable to access safe Scenesse photo protection still in the coming months so I’m sure their extremely keen to be signing off on the pm protocol.

Obviously the FDA would be working around the clock to avoid killing another summer of Scenesse protection for US EPP community and Clinuvel sales.

“” The discovery of the endogenous melanocortin agonists in the 1950s have resulted in sixty years of melanocortin ligand research.””

The never ending quest to have Afamelanotide (peptide) (SEMI) accepted for its potent ability to stimulate a natural photoprotective,cancer preventative, therapeutic “tan” was (SEMI) accomplished in 2019.

Regulator ignorance, bias, and stubborn resistance to Scenesse are the primary reasons behind this glacial journey. The evidence should be clear to all by now.

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post Posted: Yesterday, 05:42 PM
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keeping an eye on the big picture:

fda approved ema approved
eu market took 2 years to enter but is now a solid revenue generator.
usa could be much faster i e possibly 6 months to 1 year post green light.
cuv will not stop until the last available us and eu patient is receiving treatment at the uniform price.
growth in revenue will follow
the shorters will retreat, longs will prevail.
who would have thought 4 years ago about shorters at 25aud to be a problem?
In a few years someone will complain about shorters pushing cuv from 200 to 150aud


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post Posted: Yesterday, 04:13 PM
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In Reply To: PortugueseMan's post @ Yesterday, 04:17 AM

Hope they are friggin' ready by Northern summer ... its only a few months away. Better be.

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post Posted: Yesterday, 03:42 PM
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post Posted: Yesterday, 07:34 AM
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In Reply To: PortugueseMan's post @ Yesterday, 04:17 AM

And how many employees are on this mission critical task????

Imagine trying to get $100 million rollout underway while relying on a nonprofit to do all of your legwork?

How dumb would that make you?

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Desert Rat
post Posted: Yesterday, 04:53 AM
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At least Palatin is sticking to their deadlines for their 3 new peptide drug trials starting this year. Nonetheless, the stock is still mired at 58 cents/share-no joy.

[Mid-stage study underway evaluating Palatin's PL9643
Feb. 19, 2020 12:08 PM ET|About: Palatin Technologies, ... (PTN)|By: Douglas W. House, SA News Editor
The first participant has been enrolled in a 150-subject Phase 2 clinical trial assessing Palatin Technologies PL9643, a topical eye drop, in patients with dry eye disease.
The primary endpoints are inferior corneal fluorescein staining score at day 85 and ocular discomfort at day 85.
The estimated completion date is July.
PL9643 is a melanocortin 1/5 receptor agonist that dampens inflammation.

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