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post Posted: Today, 11:19 PM
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"2nd indication Q1’19"
Investor briefing March 2019 slide 6
4 days left to have this announced within their own timelines.
8 April FDA news on labelling and post marketing follow up
30 april quarterly financial report
I am also expecting the announcement of the start of the Variegate porphyria trial during the first half of this year.
First half of this year should see some news on the UK NICE and UK distribution, French reimbursement feedback etc.June: ASX200 rebalance8 July FDA PDUFA31 July full year financial report
Maybe some news on the Japanese and Australian filing too.
April, May and June we should see some updated investor briefings posted on the website too as they do their roadshow in Sidney, NY and London.
I would also hope that we will get a dividend reinvestment plan in the first half year followed by an announcement of the 2019 dividend somewhere end of August like last year.
For the second half of 2019 I would expect some update on the Vitiligo path to market/trial(s) agreed with the FDA.


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Dr Wally
post Posted: Today, 02:46 PM
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In Reply To: Verharven's post @ Today, 12:53 PM

“Another ASX-listed biopharmaceutical company to have a product application delayed (at a minimum) by the FDA recently is Starpharma Limited (ASX: SPL), despite its management team telling investors they were confident their product application would be approved.”

Thankfully its 2019 now not 2005. The FDA have worked through the mountains of data so they’d explicitly understand the science that has proven Scenesse to be way more than extremely safe. Add to that the reality that the (implant) will be cost prohibitive, strictly controlled and managed to be used only by those with severe light sensitive diseases like EPP.

The concerns of the past that have dogged this drug for decades have been well and truely quelled by the science, all’s we need now is a mature logical outlook on the situation by the regulator to see success.

I’m not saying delaying tactics won’t be applied to Clinuvel by the FDA that could possibly drag on for f knows how long, but if science, empathy, and logic have anything at all to do with their decision making process, further delays will not be happening.

Further delays or not this safe and necessary drug will not/cannot be denied for much longer!

50+ on or before PDUFA.. But hoping to see sub $20 to really be -Enjoying the final days leading up to FDA validation of Scenesse. GLTA that have seen the future and kept the faith. 😎
post Posted: Today, 12:53 PM
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The News Corp media is that morning reporting that sell-side broker Bell Potter has upgraded ASX stock Clinuvel Pharmaceuticals (ASX: CUV) to a “buy” rating.

Clinuvel is a global biopharmaceutical business headquartered in Melbourne that sells treatments for a range of genetic and skin disorders with its main product named SCENESEE that is used to treat a rare genetic skin disorder called erythropoietic protoporphyria (EPP).

Its shares are now up more than 150% over the past year after it reported a profit of $4.076 million on revenue of $8.98 million for the six month period ending December 31 2018.

The revenue and profit were up 27% and 189% respectively over the prior corresponding half year period. It also held no debt and $42.3 million cash on hand to fund its growth strategies.

Its SCENESEE product is approved and sold in the EU and the company has applied to the US healthcare regulator the FDA for permission to sell the product to certain classes of patients, with a decision from the regulator due in July 2019.

Management appear confident the product will be approved, with it reporting that approval would potentially double its EPP product’s addressable market.

However, investors should remember that there’s no guarantees for new product approval from the FDA, while anticipation of the product being approved may already be factored into the fast-rising share price.

Another ASX-listed biopharmaceutical company to have a product application delayed (at a minimum) by the FDA recently is Starpharma Limited (ASX: SPL), despite its management team telling investors they were confident their product application would be approved.

Clinuvel has a market value of $1.24 billion today based on a share price of $25.33, which suggests investors are confident it will get the US regulatory approval required. If not the stock could come under selling pressure.

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post Posted: Today, 10:52 AM
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Another big transaction gone through this morning.

10:45am AEDT 25.30 218,800


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post Posted: Today, 10:43 AM
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The ASX 300 is down around 1.3% so far. Clinuvel only down about 0.4%, so it is showing more strength than most in the index and it is very high volumes. To me this is a very positive sign. I expect Clinuvel to be down today just because the whole market is selling off, but thus far it is doing much better than expected.

post Posted: Today, 10:23 AM
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Fidelity close to gone? We’ll know next week. Another high volume day.

Maybe we end at $27 today?

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post Posted: Today, 09:20 AM
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In Reply To: NewToCli's post @ Today, 12:35 AM

Mid cycle review in February seems to be in line with PR timing.
Quote „3 month after receipt for priority
I also was hoping that it was kind of early

Hope the attachement shows


Attached thumbnail(s)
Attached Image

Attached Image


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post Posted: Today, 08:38 AM
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Not sure where the stock will go over the next 12 weeks but estimating $38-$42 the week after approval. Just my estimation so no need to comment. I’m a buyer on any weakness between now and July 8th. Could be soon as well.

Shorts may play but July 8th is coming

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post Posted: Today, 07:48 AM
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In Reply To: NewToCli's post @ Today, 12:35 AM

The mid-cycle review timing does appear to come earlier than expected which aligns with an expedited review for a decision a month earlier than the PDUFA date as the meeting should be March based on a 6 month review time from the 60-day submission date (submission in early November) so the actual review time is 8 months from submission - the FDA uses confusing language when they talk about 6 months review for PR as the review has already started by the time the applicant gets the Day 74 letter. The median time for a PR from data I posted previously is 8 months and I first took it as they usually went over time as should be 6 months, but actually is bang on the planned 8 months from submission and is what the PDUFA date is based on.

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post Posted: Today, 12:35 AM
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In Reply To: Verharven's post @ Yesterday, 08:30 AM

And again... we decrypted PWs hidden messages... the hard working team with fda questions with weekly deadlines and a mid cycle well before mid to July, and an fda statement of no need for advisory committee meeting etc all those are good indications for approval before July 8.

I just hope by then all the centers are setup all doctors are trained, all patients are informed, all registries are setup and all is negotiated with health insurances.. what a success it would be to have EPP in the USA covered this summer .. well at least I’m allowed to dream of it ...

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