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post Posted: Yesterday, 10:57 PM
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In Reply To: Boat2float's post @ Yesterday, 09:35 PM

Clinuvel isn’t able to communicate which post-marketing requirements the FDA has now decided on. It’s an
ongoing process and Clinuvel now has to commit to the requirements - if any. In the final NDA approval letter
the FDA will list the requirements and remind Clinuvel that they have accepted them.

Post marketing requirements come in many variations. It can be new clinical trials with specific emphasis on efficacy,
PK or safety. I highly doubt we will be asked to carry out any new trials.

In the EU we committed to a PIP and the Singaporean lab is working on that.
The FDA will also require a pediatric plan and this will probably be outlines in
the post marketing requirements.

The EMA set some strict rules in the PASS. It’s an open question if the FDA will require
a similar registry. If they do, it will be part of the post marketing requirements and we will learn about it
in the final app letter when it’s published online or directly from Clinuvel.

Said 'Thanks' for this post: Farleap11  balimike  
post Posted: Yesterday, 09:35 PM
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“FDA expects to communicate labelling and post-marketing commitments – if needed – by 8 April 2019”

So I guess nothing happened?

post Posted: Yesterday, 02:18 PM
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It looks like afamelanotide has made it onto Finland’s list of medicinal products. I’m not 100% sure what this means in terms of access/state reimbursement, it might be worth giving the main EPP expert centre in Finland a call, Helsinki University Central Hospital. Do we have any Finnish speakers on the board?

I appreciate there are probably only a handful of people suffering from EPP in Finland (28?, assuming 1:200,000 and a population of ~5.5mil), however every new country providing treatment is a step forward and potentially a new life without pain for those receiving treatment!
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Said 'Thanks' for this post: Verharven  odi01  Frogster  macgyver  oystercatcher  landrews  Yoloding96  PunkassDerm  blackm3  
Desert Rat
post Posted: Yesterday, 07:46 AM
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In Reply To: johnnytech's post @ Apr 20 2019, 07:57 AM

If you do a PubMed search for science papers listing Clinuvel's Emile Rodenburger as an author, there is a single listing which does not involve anything pertinent to Clinuvel, afamelanotide or pigmentation (abstract follows). Dr. Rodenburger has a Pharm D and an MS, and according to the Clinuvel website, is undergoing further training to become the Chief Scientific Officer for the company. That's all fine and well, but drug development companies usually hire personnel with established scientific credentials in the pharmacology of the drug they are developing. They don't do on-the-job training, which is absurd since there are people with the appropriate scientific backgrounds to be a Chief Scientific Officer of a company marketing the first-in-class melanotropic peptide. Like I said before, PW is probably keeping expenses low to save money and get the drug approved in the US, before additional personnel are hired and new clinical indications are developed. Hopefully, this will change in a few short months. GLTA

Stem Cells. 2008 Dec;26(12):3150-61. doi: 10.1634/stemcells.2008-0219. Epub 2008 Aug 28.[/b]
A cross-talk between stromal cell-derived factor-1 and transforming growth factor-beta controls the quiescence/cycling switch of CD34(+) progenitors through FoxO3 and mammalian target of rapamycin.
Chabanon A1, Desterke C, Rodenburger E, Clay D, Guerton B, Boutin L, Bennaceur-Griscelli A, Pierre-Louis O, Uzan G, Abecassis L, Bourgeade MF, Lataillade JJ, Le Bousse-Kerdilès MC.
Author information

Cell cycle regulation plays a fundamental role in stem cell biology. A balance between quiescence and proliferation of hematopoietic stem cells in interaction with the microenvironment is critical for sustaining long-term hematopoiesis and for protection against stress. We analyzed the molecular mechanisms by which stromal cell-derived factor-1 (SDF-1) exhibited a cell cycle-promoting effect and interacted with transforming growth factor-beta (TGF-beta), which has negative effects on cell cycle orchestration of human hematopoietic CD34(+) progenitor cells. We demonstrated that a low concentration of SDF-1 modulated the expression of key cell cycle regulators such as cyclins, cyclin-dependent kinase inhibitors, and TGF-beta target genes, confirming its cell cycle-promoting effect. We showed that a cross-talk between SDF-1- and TGF-beta-related signaling pathways involving phosphatidylinositol 3-kinase (PI3K)/Akt phosphorylation participated in the control of CD34(+) cell cycling. We demonstrated a pivotal role of two downstream effectors of the PI3K/Akt pathway, FoxO3a and mammalian target of rapamycin, as connectors in the SDF-1-/TGF-beta-induced control of the cycling/quiescence switch and proposed a model integrating a dialogue between the two molecules in cell cycle progression. Our data shed new light on the signaling pathways involved in SDF-1 cell cycle-promoting activity and suggest that the balance between SDF-1- and TGF-beta-activated pathways is critical for the regulation of hematopoietic progenitor cell cycle status.

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post Posted: Yesterday, 01:48 AM
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In Reply To: Johnny H's post @ Yesterday, 12:40 AM

Which means we could get paid early for 2019 orders.

Johnny H
post Posted: Yesterday, 12:40 AM
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In Reply To: Frogster's post @ Apr 20 2019, 03:20 PM

It's a good problem to have; everyone is paying on time.

Clinuvel until my bowels release for the last time.

post Posted: Apr 20 2019, 03:20 PM
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In Reply To: Justinian's post @ Apr 20 2019, 02:58 PM

If you aggregate the receipts from customers on a quarterly basis from Q1 12/13 until Q4 17/18 and calculate the proportion that each of these has been for total receipts, then Q1 has averaged 26% of RfC, Q2 21%, Q3 14% and Q4 39%. So, statistically Q3 has been on average the lowest quarter, and Q4 by far the strongest.

Each year can vary quite a bit from these averages due to timing factors, and of course there's a strong growth rate underlying all the data which makes for an imperfect analysis. I think we mostly thought Q2 in the current financial year was surprisingly weak. CUV reported this as being in part due to customers paying more quickly than in the corresponding prior period but they haven't explained if the same behaviour will repeat, or if it will likely have a positive or negative effect on the Q3 results.

FWIW I'm modelling that Q3 will be better than Q2 was, but in light of the timing factor question, my conviction is not strong on this.

Dr Wolgen is a magician.
His end game for Scenesse will impress, or even amaze.
En route, along with glimmers of truth, there will be distractions, illusions, sleight of hand and misdirection.
Enjoy the ride.

Said 'Thanks' for this post: Johnny H  Justinian  seeva222  
post Posted: Apr 20 2019, 02:58 PM
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In Reply To: seeva222's post @ Apr 20 2019, 02:09 PM

Receipts from customers in the Jan 31th, 2019 report was 2,608. October 31st 2018 was 10,705. July 30th 2018 was 10,388. April 30th, 2018 report was 3,480.

So even after more customers being served since the 1Q 2018 timeframe, the most recent quarter (4Q 2018) was still the smallest in the last year. I think the fact that the customers purchase the implants ahead of time offsets the fact that there is a delay in reporting. for reference

Said 'Thanks' for this post: Johnny H  
post Posted: Apr 20 2019, 02:09 PM
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In Reply To: Justinian's post @ Apr 20 2019, 01:16 PM

Isn’t this the lowest quarter because it’s out of season? Cash receipts are on a delay.

post Posted: Apr 20 2019, 01:16 PM
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I'm mad at myself for buying for the last time probably a few weeks ago. April 30th is supposed to be the next quarterly financial report. This should have a significant increase since it will be the beginning of the in-demand season and there have been hints that more countries in Europe are online. I'm guessing this will be the lowest the stock will be ever, unless it dips more between now and April 30th.

Even if the FDA had issues, I can't imagine it being worse than "give us more data" with a delay. And there would be other profits coming in from other countries which would bump up the stock price in this scenario and a probable ASX200 inclusion would also bump the price by the time the FDA reaches a decision.


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