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stmccallum
Posted on: Oct 11 2019, 02:39 AM


Group: Member
Posts: 100

I wonder how long before a take over bid emerges? Galderma a 10B dollar Nestle spinout just announced Flemming Ornskov as their CEO and Thomas Dittrich will be their CFO...... Two seasoned exec who drove Shire to the $62B buyout by Takeda. "Galderma plans to become the biggest independent dermatology company on the planet".....
https://endpts.com/flemming-ornskov-takes-o...ans-for-growth/

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stmccallum
Posted on: Oct 9 2019, 05:16 AM


Group: Member
Posts: 100

Your insurance won't pay for it, but if you can find a Doc or licensed HCP to prescribe and administer it yes you will have to pay out of pocket.
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stmccallum
Posted on: Oct 9 2019, 04:31 AM


Group: Member
Posts: 100

Yes it is not the mandate of the FDA to dictate the practice of medicine, although they try.Drugs are approved for specific indications based on a body of safety and efficacy data.Clinicians decide if the individual patients risk benefit ratio is suitable for them to receive the medicine.....
Everything else is regulatory over reach.....
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stmccallum
Posted on: Oct 9 2019, 03:56 AM


Group: Member
Posts: 100

Congrats all its been a long time coming......
Remember Epitan.....
Got to love the FDA press release
Today’s approval is one example of the FDA’s ongoing commitment to encourage industry innovation of therapies to treat rare diseases, and work with drug developers to make promising new therapies available to patients as safely and efficiently as possible.”
Yeah 5 years after EMA approval....... and how long after Italy????
Forgot to add those details....
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stmccallum
Posted on: Oct 2 2019, 12:19 PM


Group: Member
Posts: 100

Label, REMS, and commitments for additional studies can go right down to the wire (last 24-48 hours...)
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stmccallum
Posted on: Sep 8 2019, 12:35 PM


Group: Member
Posts: 100

Sweet I’ve been in Denver for the last few days would be nice to have a mountain home...
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stmccallum
Posted on: Sep 6 2019, 10:12 AM


Group: Member
Posts: 100

Sweet looking Karts wonder what their top speed is
Hell some big “kids” could enjoy them as well.....
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stmccallum
Posted on: Sep 6 2019, 04:55 AM


Group: Member
Posts: 100

Haaa do I roll two dice for the % price increase?
But based on Joachim De Schrijver work
https://lib.ugent.be/fulltxt/RUG01/002/062/...013_0001_AC.pdf.a 30-40% jump is very possible.
See figure 3 is realistic based on prior data from other similar companies.
One confounding element is the ASX listing not sure how that will play out.
Part of me is hoping for an early reply by FDA and short squeeze...... with a 50% pop....

But the FDA has not been the most productive with early delivery of replies outside of the Oncology division.
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stmccallum
Posted on: Sep 5 2019, 11:22 PM


Group: Member
Posts: 100

What are best estimates on share prices
Pre approval and day after?

Trying to calibrate my expectations
Thanks
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stmccallum
Posted on: Aug 22 2019, 01:08 AM


Group: Member
Posts: 100

The FDA can send a draft label to the sponsor right up until the last days before the PDUFA and say take it or leave it.
Not the best way to negotiate with a sponsor in good faith but it can happen. Also not a way to have meaningful discussions on any post marketing studies they may want the sponsor to run.

But anything is possible right up until the PDUFA date.

Just look at what happened to Vascepa initially given priority review without the need for an Ad Com, PDUFA date of July to now we need an ad com earliest we can accommodate is November..... new PDUFA end of Dec.....oh well so much for that priority review....
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stmccallum
Posted on: Jul 31 2019, 12:00 AM


Group: Member
Posts: 100

The FDA sets PDUFA dates based on calendar days not working days.

The review team will have finalized their review and have received final sign off ahead of that date.
They will typically send the final recommendations (e.g. CRL or Marketing approval) to the company Thursday or Friday just before the Sunday deadline.
Of course they should have at that time been working on the label with back and forth revisions and any outstanding commitments (REMS, Pediatric trial commitments etc) with the agency so there will be some people with much more insight than the rest of us on here...
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stmccallum
Posted on: Oct 31 2018, 11:22 PM


Group: Member
Posts: 100

Great find, ajshare, the precision of the date makes me wonder.

That would mean that the FDA completed their review and would have informed the sponsor on Sep 25th of their priority review and PDUFA date of Feb 25th 2019?

Magellan wouldn't be guessing, would they?? Why risk an incorrect guess???

Could it be that they are hearing convincing whispers? Just a thought? No evidence one way or the other.
Again great find ajshare.
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stmccallum
Posted on: Jun 3 2016, 09:57 PM


Group: Member
Posts: 100

It mostly applies to the DMD situation but you could easily see it expanded.

Drugs for DMD (a lethal disorder) only limited efficacy data 12 patients in phase II with extension data, patients and their parents want access to the drug,

FDA is having problems evaluating the benefit. Risks not zero but the kids all go on to die from their disease so most are willing to take the risks.

Parents what access to the treatment, companies are waiting on a reply.....from the FDA..... Stalemate

Resolution

FDA says, you can have the drug through expanded access programs, the company has to agree to provide the drug and manufacture to all the standards expected etc...

FDA to company, you can only charge back your costs..... nothing more.

FDA to company: "Give us more data or we won't approve",
FDA to patients: "you can have access to meds, ask the company for them at cost"

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stmccallum
Posted on: Jun 3 2016, 06:46 AM


Group: Member
Posts: 100

FDA just released industry guidance on expanded access for investigational drugs; in this case focused on Sarepta for DMD...

Clinuvel and Scenesse could follow the same path..... you don't hear much about expanded access programs.... from Clinuvel.

Oh yeah Cost: A company could only charge patients for “direct costs”;

http://blogs.barrons.com/stockstowatchtoda...ned-to-sarepta/

FDA releases industry guidance on expanded access for investigational drugs; could provide the drug to DMD community without approving right now.

Expanded access guidance documents point to a path for DMD patients to get eteplirsen without FDA approval: The FDA documents released today lay out a potential path whereby eteplirsen could become available to DMD patients, at cost, without jeopardizing the integrity of the FDA approval process.

Making a drug like eteplirsen available through an expanded access process was already possible and had been considered for a while, but many questions lingered, including process, timing, cost, reimbursement.

Today’s guidance by FDA helped answer a number of these questions.

Most importantly, it provided a simple roadmap by which the drug could get to patients quickly, thus relieving the significant political pressure being felt by the agency, without FDA having to approve the drug prior to the completion of randomized controlled trials.




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stmccallum
Posted on: Jul 12 2015, 11:35 PM


Group: Member
Posts: 100

Seeva222

Thanks sorry I missed that in your note.

I could not agree more management have missed a huge opportunity here.

EU summer is lost, and FDA submission is going to be delayed, even with a rolling review the supplemental real world use data is going to be delayed.

It really irritates me to see huge salaries and bonuses with sub par execution of strategy.

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stmccallum
Posted on: Jul 11 2015, 10:24 PM


Group: Member
Posts: 100

Where did I say anything about promoting?
I want answers about the missed objectives
1) Acceptable RMP which permits a
2) Launch which produces
3) Sales
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stmccallum
Posted on: Jul 11 2015, 11:30 AM


Group: Member
Posts: 100

American Porphyria Foundation on Facebook.
I got booted from the Photoprotection Network with Clinuvel for Asking Lachlan point blank questions when they were going to announce the failure of the RMP.......
Never responded to my question just booted me off the page.
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stmccallum
Posted on: Jul 11 2015, 10:58 AM


Group: Member
Posts: 100

And yes the FDA does spoon feed smaller companies, but they only go so far.
As we saw with the RMP and the EMA review they don't accept trash in return.
The formal reply really highlighted how unhappy the reviewers were with the RMP that Clinuvel provided.
Again if they could have written in all CAPS I think they would have.
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stmccallum
Posted on: Jul 11 2015, 10:49 AM


Group: Member
Posts: 100

I like to give backhanded complements..... hypocrite.gif
I was expecting to get tossed from the AFP board as well.
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stmccallum
Posted on: Jul 10 2015, 12:09 AM


Group: Member
Posts: 100

Hunter I have some concerns with the way in which you feel it is satisfactory for PW to run the company....

A quick point of reference on the Fiduciary Duties of a CEO, see below. As you may be aware Clinuvel is not a private company....

The biggest failures come in the area of disclosure.....
I have yet to see a disclosure on the failure of the risk management plan for phase IV........and the 6 month delay in launch in the EU.


Fiduciary Duties
Both the board of directors and the CEO of a small business have a fiduciary responsibility to the business's shareholders. The fiduciary duties are legal concepts that form the basis of a CEO's legal relationship with his company's owners. According to the American Bar Association, courts have ruled that a CEO's relationship with his small business's shareholders carries more legal responsibility than his relationship with his company's creditors. This is because the creditors' relationship with the company exists purely as a result of a legal contract. The shareholders' relationship with the CEO, by contrast, entails both a binding contract and the trust of that CEO in controlling the shareholders' property.


Duties of Care, Loyalty and Disclosure
A CEO's legal responsibilities to his company's shareholders are broken down into three distinct fiduciary duties: the duty of care, the duty of loyalty and the duty of disclosure. The duty of care refers to the CEO's responsibility to consider all of the available information relevant to business decisions, including the advice of experts and employees. The duty of care also includes the responsibility to understand and evaluate the company's day to day operations and the terms of agreements. The duty of loyalty requires that a CEO always acts in the best interest of a business's shareholders, and that he places that interest above his own in business decisions. This includes the responsibility to avoid conflicts of interest. Finally, the fiduciary duty of disclosure mandates that a CEO fully inform both the board of directors and the shareholders about the major issues facing the business.


Business Judgment Rule
In legal proceedings, the business judgment rule typically protects the CEO from the corporation's liabilities and losses. This rule basically states that a CEO is not personally responsible for the shareholders' losses if he acted honestly, openly and with the best interest of his company in mind. Under the business judgment rule, it is the responsibility of shareholders to demonstrate a CEO's failure to uphold his fiduciary responsibilities. In limited circumstances, such as the sale of the small business to a new owner, the business judgment rule does not apply, and it becomes the burden of CEOs and company directors to demonstrate that their actions were in the company's best interests.

reference
http://smallbusiness.chron.com/legal-relat...ceos-33637.html
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stmccallum
Posted on: Apr 10 2015, 11:24 AM


Group: Member
Posts: 100

After completing a doctorate in organic chemistry, Sawyer went to work in Kalamazoo, Mich., for The Upjohn Co., a drug maker later acquired by New York-based Pfizer.

He said his tenure at Upjohn was punctuated with his research group's work on an HIV/AIDS drug, which drew national television coverage in 1990.

He next went to work in Ann Arbor, Mich., with drug firm Parker-Davis/Warner-Lambert Co., which was also later gobbled up in a Pfizer acquisition.

Sawyer spent the better part of the past decade with Ariad Pharmaceuticals Inc. in Cambridge, where he became a senior vice president. He conducted early research on the anti-cancer molecule for which New Jersey-based drug giant Merck & Co. Inc. paid Ariad $75 million and pledged some $900 million more to help commercialize.

Senior Vice-President, Drug Discovery; prior positions were Vice-President and Director
ARIAD Pharmaceuticals, Inc.
1997 – 2006 (9 years)Cambridge, Massachusetts USA

Global Chemistry Leader & Senior Director, Pfizer Research Technology Center
Pfizer
2006 – 2007 (1 year)Cambridge, Massachusetts USA

Chief Scientific Officer & Senior Vice-President, Drug Discovery and Innovative Technologies
Aileron Therapeutics
2007 – 2013 (6 years)

Distinguished Scientist & Head, Peptide Drug Discovery and Innovative Technologies
Merck
2014 – Present (1 year)Boston
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stmccallum
Posted on: Apr 10 2015, 04:42 AM


Group: Member
Posts: 100

Tomi Sawyer is chief scientific officer of Cambridge biotech Aileron Therapeutics Inc.
Aileron is a developer of cancer treatments made from short versions of proteins known as peptides, which Sawyer studied extensively -- and successfully -- during his doctoral work at the University of Arizona.

http://www.bizjournals.com/boston/blog/mas...n.html?page=all
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stmccallum
Posted on: Oct 25 2014, 01:46 AM


Group: Member
Posts: 100

Unless there is other material news they want to share with the markets?
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stmccallum
Posted on: Oct 24 2014, 09:00 PM


Group: Member
Posts: 100

Finally yes
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stmccallum
Posted on: Mar 15 2014, 03:59 AM


Group: Member
Posts: 100

Wouldn't it be charming if Clinuvel took the UK up on the new breakthrough therapy plan....

UK's breakthrough therapy plan goes one better
March 14, 2014
The UK drug regulator has seen the US FDA’s bet and raised it, today announcing a scheme that looks like its American counterpart’s “breakthrough therapy” designation but going a step further by offering the opportunity for early access to experimental innovative medications.
The two-step programme could allow patients to use unapproved drugs outside the clinical trial setting based on positive phase II data alone, before UK or European agencies have authorised commercial sale. Though risky, this approach attempts to ease the concerns of the pharma and biotech sector as well as patient groups that regulation cannot keep up with the pace of innovation.
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stmccallum
Posted on: Jul 7 2012, 12:06 AM


Group: Member
Posts: 100

Excellent thank-you
September is going to be a.very exciting month.!!!!!!
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stmccallum
Posted on: Jul 6 2012, 09:54 PM


Group: Member
Posts: 100

Excellent thank-you
September is going to be a.very exciting month.!!!!!!
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stmccallum
Posted on: Jul 6 2012, 09:51 PM


Group: Member
Posts: 100

I will no response so far
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stmccallum
Posted on: Jul 4 2012, 05:17 AM


Group: Member
Posts: 100

Thanks Paufin,

I looked at the Nomura report as well when I was calculating my dates.

It does point to a Sept response, thus I am optimistic that all the pieces triangulate on a Sept EMA response to the MAA.

It will certainly make for a potentially very exciting Sept........for us all.

I also submitted a request for clarification on the date through the investor link on the Clinuvel website. I am not holding my breath for a response thought as other requests for information have also gone unanswered in the past.
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stmccallum
Posted on: Jul 4 2012, 02:58 AM


Group: Member
Posts: 100

Hi Paufin

I was counting calendar working days, but I would be delighted if day 120 was in June.

As with calendar working days, day 210 would be on or about Nov 23th, vs. ~Sept 3-4 with total calendar days.

Anyone have any insights?

Wonder if we could get an answer on this item from Clinuvel, its not like its a secret really.

Although they did promise the Feb 2012 submission was to have occurred in Dec of 2011 and there are a few other dates they have missed in the past.
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stmccallum
Posted on: Jul 3 2012, 09:06 AM


Group: Member
Posts: 100

Regarding the EMA submission, are we not coming up to the 120 day review?
By my calculation on or about July 23. Anyone else have any insights?
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stmccallum
Posted on: Feb 29 2012, 11:18 AM


Group: Member
Posts: 100

The compensation is another thing that is out of range.

Having recently reviewed the 2011 Venture Capital Executive Compensation Survey Life Sciences Report which is heavy on US data.

I could only find one other CEO/President non founder who had a base salary of 500K and they were running a Profitable Medical Device and Diagnostic company with revenue of 50-100M.

None of which currently describes Clinuvel, unfortunately.
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stmccallum
Posted on: Feb 29 2012, 01:30 AM


Group: Member
Posts: 100

Censere
I appreciate your feedback.

One point that Wolgen makes that needs more clarification

"As Wolgen points out (and it is true), most companies only achieve that after many more years and far more expenditure."

Here he is stretching reality a bit.

I agree they changed indications from cosmetic to EPP,

BUT they did not have to go back and develop a new compound or formulation or repeat all the preclinical and safety assessment trials as specified by the EMEA or FDA, this is were a great deal of time is spent. So "skipping" that phase they saved 4-6 years, so when you look at it in this view how fast are they really, it has taken them 6 years to complete phase II - III trials.
Saying they are so much better than the rest of the industry is in my opinion a stretch.

They re-purposed the drug for a new indication pure and simple, they are not alone in doing this, it is a time and cost efficient way to develop medicines for new indications.

Re less expenditure, this is an orphan indication, the bulk of the expenses in phase II-III are on patient trials (orphan indications) do not require 2000 patient trials for 5+years, so again look at the costs relative to other orphan indications and break the cost down on a per patient/year basis and see if that message still sounds so strong.

In fact if they were so frugal with their spend why are we looking at a possible need for more fund raising?

One last point

If all the work they did was so strong why did the FDA say to them you need to do phase II trials instead of moving to phase III trials as they requested what was the reason for the push back??? What was wrong with the phase II trials in EU and Australia conducted to that point??

On a final note I am patiently awaiting formal word of acceptance of the submission, as far as I am aware I have not seen a press release to this effect.
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stmccallum
Posted on: Feb 28 2012, 10:26 AM


Group: Member
Posts: 100

Yeah I was in a mood when I saw the video, it takes so little to push it to the next level with out the background noise and produce a more professional piece. Think of the impact on the 100's or 1000's of people who watch this.

Its like some one said we need to get this out there, they had not though through all the details of what is required to get a professional job done and just did the the minimum without a care as to what the end product sounds or looks like.

Its the same way they have universally missed every deadline they have set........ and go on silent mode and think we won't notice.

Just speaks to poor planning, does nothing to rebuild my very eroded confidence.

What next we will hear that the file has not been accepted because it does not meet all the requirements?

I have been in this for over 7 years, I believe in the science, and the patient need. I am just very unhappy with managements execution. With the two principals having ~ 10% of the company float, there should be some negative impacts for missing on key endpoints.
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stmccallum
Posted on: Feb 28 2012, 05:56 AM


Group: Member
Posts: 100

What is going on with this company, could they not afford or see the virtue of recording this in a professional studio, so that the background noise is not a distraction???

I have been a longterm shareholder of this company and at times have been willing to toss it all in and move on.

This sort of production is so typical, I somewhat expected to see a waiter come into the scene.


http://www.clinuvel.com/en/news/webcasts/i...-off-in-the-end
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stmccallum
Posted on: Jun 22 2011, 04:18 AM


Group: Member
Posts: 100

It does not take 6 months.

Takes at most 4-6 weeks with a clean data set. Not sure what they are doing in the 6 months??

They have done this before what is new this time around?

Fire the data management group and stats and programmers if they can't meet a shorter timeline.

This company has never met a reasonable timeline........

Yet two insiders control 10% of the company handed to them as part of their pay package.

Have either of them made an open purchase of shares????
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stmccallum
Posted on: Jun 21 2011, 10:12 AM


Group: Member
Posts: 100

Hey Joe you hit that one out of the park
Investment Memo from clinuvel Nov 20th 2007

http://clinuvel.com/resources/pdf/analyst_...20071120RRS.pdf

Page 8 is the most telling
Comments
Absolute Capital Management (ABCAP) is the main shareholder in Clinuvel. Four of the investment funds (Absolute Octane Fund, Absolute
Return Fund – Europe, Absolute Activist, Value Fund and European Catalyst Fund) are assumed to hold a total of appx 20% of the issued
capital of the Company. The investment strategy of ABCAP is not transparent.
The sharp decline in the share price over the last 6 months may be in connection with the uncertainties regarding the major shareholder
(ABCAP).

The Management is currently on a worldwide tour and visiting all major shareholder. There have been attempts to get non-core shareholders out
of the stock, to stabilize the shareholder structure.
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stmccallum
Posted on: May 12 2011, 11:00 PM


Group: Member
Posts: 100

All companies developing new chemical or biologic entities are required to submit pediatric investigation plans (PIPs) if the drug is say for Prostate cancer or Breast cancer and the event rate in kids is remotely low then there is a waiver. But where kids also suffer from the condition they want to see a plan where the sponsor is going to evaluate the safety and efficacy in a pediatric population.

If you suffered from EPP and/or had a child that suffered from EPP would you not seek out whatever treatment would be available and or want what is approved for adults.
Also from a clinicians perspective would you not want to know what the best and safest dose would be for your pediatric patients?

The patient groups would pretty much demand to know what doses are needed in kids and what the outcomes would be.

Glad to hear the EMEA feels the dossier will be ready with the completion of the recent data from the phase III trial.
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stmccallum
Posted on: Feb 9 2011, 02:13 AM


Group: Member
Posts: 100

Yes I would like to see his bio and why he is getting shares and sitting on the board. This appointment leaves a lot of unanswered questions for me.
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stmccallum
Posted on: Jan 20 2011, 11:22 PM


Group: Member
Posts: 100

Royco

A key part of early drug development is assessing the photo-toxicity risks for a compound to see if the compound or its metabolites have any potential for sun sensitization. Good example take a dose of doxycycline and go out in the sun, even the most darkly pigmented with experience a burn. Most drugs with a positive photo-tox screen get dropped as this risk is seen as too high for common conditions (BP meds etc) but clearly for oncology conditions and other life threatening conditions there could be a real benefit to SCENESSE to help alleviate the side effects and still permit the clinical benefit. PUVA is a good example, what happened to those trials??
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stmccallum
Posted on: Jan 20 2011, 03:27 AM


Group: Member
Posts: 100

Looks like you are right, everyday around 3:30 we see the price decline.

Also what is "fairdinkum"
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stmccallum
Posted on: Jan 11 2011, 03:59 AM


Group: Member
Posts: 100

Revenues Why are they waiting for the second quarter to report the revenues from Italy??

" Finally, I would like to note that the company has received its first
revenues from the Italian 648/96 program, which makes SCENESSE®
available by prescription to EPP patients in Italy, with Clinuvel being
reimbursed the cost of supply by the Italian national health service.
These revenues will be apparent in the second quarterly financial
report for 2011 and have been earmarked by the company to assist
in the funding of our pediatric program for EPP"
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stmccallum
Posted on: Jan 4 2011, 06:47 AM


Group: Member
Posts: 100

RE NSV phase II trial to begin in 2011, is that vague enough for everyone?

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stmccallum
Posted on: Dec 25 2010, 07:07 AM


Group: Member
Posts: 100

Yes sorry did not check the volume before I posted.
Oh well at least some shares changed hand above 2.00 range.
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stmccallum
Posted on: Dec 24 2010, 01:13 AM


Group: Member
Posts: 100

A trade for 3.00 just went through today, glad I pick up some shares yesterday at 2.07.....
It is going to be a very interesting New Year......

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stmccallum
Posted on: Nov 23 2010, 07:35 AM


Group: Member
Posts: 100

Follow up
I received a response to my inquiry about the status of CUV029.
"CUV029 had exceeded its recruitment target (70) and 76 patients are now enrolled in the trial. For an orphan indication like EPP, this is an encouraging sign of the support the trials have from the patient community. "
I asked for a last subject last visit date but no information was forth coming......


Re clinicaltrials.gov and WHO International Clinical Trials Registry Platform
I received the following response.
"I encourage you to review the company's website and announcements prior to any third party site when looking for information on clinical trial progress."

There are multiple reasons to update the two sites and have them reflect what is actually happening.
1) patients go there to look for trials, it is as good as free advertising for new subjects
2) it is a quick status update of ongoing trials.
3) it is an "independent" body that pretty much every other company is placing accurate information on the progress of their trials so I would suggest that a similar effort from Clinuvel, would be standard practice.

On a final note for once in a very long time I was pleasantly surprised at the SP activity at the end of the day.

Good luck to all.

2011 is going to shape up to be a very exciting year........ can't wait to see the first revenue booked for the Italian sales.
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stmccallum
Posted on: Nov 23 2010, 01:30 AM


Group: Member
Posts: 100

The November newsletter has reduced some of my concerns.
But having both registries listed as not yet recruiting is just sloppy and unprofessional.

Next big news will be headline results for confirmatory trial and then note that the MMA for the EMEA is complete and submitted.

Also a note about planned listing on a major index would also be an upside


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stmccallum
Posted on: Nov 22 2010, 11:31 PM


Group: Member
Posts: 100

Don't get me wrong.
I believe in the drug, as well, I have held for over 4 years.
Its the management that is the problem!
IMHO.
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stmccallum
Posted on: Nov 22 2010, 02:53 PM


Group: Member
Posts: 100

Hey Rabbit
Do you have any idea if trial CUV029 has actually started.
This is the confirmatory trial in Europe

Clinicaltrials.gov and
the international clinical trials registry platform both list this trial

NOT YET RECRUITING???

http://apps.who.int/trialsearch/Trial.aspx...lID=NCT00979745
http://clinicaltrials.gov/show/NCT00979745

Also the number of subjects on the trials registry (70)
does not match with what is in the year end report (40)

Also the year end report on page 27 indicates that this trial commenced this year??????

Does setting up sites but not recruiting patients count as commenced?

In my mind no....

First subject first visit is a commenced study........

Anyone want to call up Wolgen and ask for an explanation????

It is likely that they have not updated the registry (last update Sept 2009) but this is just SLOPPY and not a sign of them being on top of all the elements.

A better signal of confidence would be an indication that all subjects have been recruited and they are currently completing their assessments, and last subject last visit will occur on .....
with an expected database freeze and lock on the ...... for headline data on .... with a final study report on ......





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stmccallum
Posted on: Nov 22 2010, 02:03 AM


Group: Member
Posts: 100

Rabbitrun
I agree with the need for confirmatory data, and comprehensive understanding of the safety. All this can be done, with good planning. My biggest concern is the repeated failure to meet timelines. That is were my confidence drops. I have held significant quantities of this stock for over 4 years now, and the only example of a positive surprise on timings was when the Italian regulatory agency gave the surprise positive endorsement, (most likely to address patient and expert dermatology requests and not the companies).

So I fully expect that the 3-4Q 2011 filing with the EMEA will pass and we will be told they are crossing their t's and dotting i's.

That is not acceptable and it plays into why the share price is where it is.

Just my opinion.

A share consolidation would not be required if the company was delivering on timelines that they announce and then fail to uphold.

One final piece does anyone have any idea when we are going to see revenues from the Italian sales show up on the balance sheet, or are they as slow at collecting and reporting income just like everything else?



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stmccallum
Posted on: Sep 18 2010, 02:39 AM


Group: Member
Posts: 100

Yes a concern I have as well, even with multiples of the market cap for Clinuvel.
This would be a tempting target for a large pharma looking to diversify, one with an established derm franchise
i.e. how GSK bought Stiefel for 402 million

Allergan synergies are pretty clear Mkt Cap 19 Billion
Smaller players Medicis Mkt Cap 1.8 Billion

Also number of private companies
Galderma
Cutanea
SkinMedica
Ferndale Labs
Merz Pharma
etc....
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stmccallum
Posted on: Jul 12 2010, 01:36 PM


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Posts: 100

Sorry Motegi the costs quoted are per implant.


Indicative cost of treatment: Price up to € 5,375.00 per implant.
6 per year = 32250 Euros / year (~40,000 USD /yr (Conversion 1.26 USD/Euro rate as of July 9 2010)

Sources
http://www.pneumonet.it/scientifico/legisl...amelanotide.pdf
http://www.x-rates.com/d/USD/EUR/graph120.html


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stmccallum
Posted on: Jul 9 2010, 02:22 AM


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Posts: 100

Ad0304s
Sorry this is not the final data, it is a paper validating the patient reported outcome (PRO) used in the Phase III trial.
You need to demonstrate good content validation, reliability, repeatability etc... of the questionnaires used to demonstrate a change in the endpoint you are measuring is meaningful, and not just occuring at random or for other reasons.
From this they have determined that Exposure time Times Freedom from Pain (ETFP) model demonstrates the highest sensitivity.
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stmccallum
Posted on: Jun 23 2010, 11:18 PM


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Note the patient is 10 days into his therapy and by his own report
"was far too much out there in the great weather"

will wait for the full dataset for phase III.

Any idea of when we are going to see this??
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stmccallum
Posted on: Jun 23 2010, 07:31 AM


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Posts: 100

Heike,
I ran your text through google translate so that others can get the spirit of your message.

10:08:09 12:03 Hello My name is Heike Schmitt 40 years old and just take part in Clinuvel study on EPP. Toll the drug, it helps one feel like Christmas and Easter is on the same day! No pain, no gloves, etc. a normal life, unfortunately we have no way according to the study of this drug to kommen.Ich hope it will at some point but the market does each of the disease has probably knows what I mean. Lives anyone is near the beautiful Sauerland Meinerzhagen ?????????????? Greetings Heike


The message you have shared is truly wonderful. I hope you can continue to get the drug. Tell your doctor you need to travel to Italy to get the drug longterm.

Keep us posted of your progress.
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stmccallum
Posted on: Jun 15 2010, 01:59 AM


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Posts: 100

thanks johhnytech

The ability to understand the reasons that the FDA uses to require new studies and or more information is becoming less and less transparent, far from the position they are trying to achieve and portray to the outside world.

Now when is the Phase III data coming from CUV.........
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stmccallum
Posted on: Jun 12 2010, 04:54 AM


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Posts: 100

Johnny what drug got trashed by the FDA?

I agree this is a significant issue, if the FDA is worried about huge off label or blackmarket use then this is dead in the water.

They don't want to deal with the headaches of senate hearings and any more bad press on how they f up.

they are human and subject to the same pressures we all are, they end up on the front page of the newspaper when something goes not as planned.
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stmccallum
Posted on: Jun 8 2010, 01:01 PM


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Posts: 100

Johnny Tech
The practice of medicine is governed by physician and health care provider decisions.
Your HCP could prescribe Growth Hormone to address symptoms related to a condition unrelated to the indication for which the regulators have approved the drug.
The same goes for any other drug on the market unless there are specific restrictions placed on its use (i.e. acutane) where a registry program is in effect for anyone wishing to obtain the drug. Adolor's Entereg.

Otherwise a new chemical entity or biologic product is approved for a specific indicaiton
and pharmacy benefit programs limit access to individuals with that specific problem

If a HCP wants to write a script for an off label indication and the patient wants to pay out of pocket that is something they can do without regulatory approval, it happens all the time..... (Botox was not initially approved for cosmetic uses)

For regulatory approval for example the FDA asks two questions of panels reviewing new applications.

Does the submitted data substantially establish the efficacy of the product, and does the safety profile warrant approval.
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stmccallum
Posted on: Jun 8 2010, 04:45 AM


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Posts: 100

I was not aware fo the details of the price manipulations of the share price.
That is a worry I have for CUV as well.
Forunately Australia has some high hurdles for acquiring a company but nothing is airtight.

I saw the Ipilumimab story a couple of years ago when they where presenting their prostate cancer data at Prostate Cancer Foundation scientific retreat.
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stmccallum
Posted on: Jun 8 2010, 02:38 AM


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Posts: 100

Benjammin 10 months for metastatic melanoma is beyond the scope of most medicines.
Dendreon's prostate cancer vaccine gave 12 weeks of survival advantage.
Both these numbers are median survivals so 50% will live much longer and 50% will live shorter.
But 10 months is a huge improvment over the current standard of care.

BMS will get an accelerated review and if the safety profile is good it will be on the market before the end of the year.
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stmccallum
Posted on: Jun 8 2010, 02:35 AM


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Posts: 100

Royco
You only have to look to Monsanto and a few other companies that create genetically altered seeds which can tolerate new generations of herbidices which they also sell to get an idea of contamination of the food and water. Now they have super resistant weeds that require even more herbicides, back to the older more toxic versions. These are intentionally applied to food which we all ingest. Now they are finding relationships to autism.... and other neurologic conditions.
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stmccallum
Posted on: Jun 1 2010, 05:07 AM


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Posts: 100

Rimini conference

http://www.dermatologia2010.com/programma/

Page 19 of 29

13:45-14:05 Afamelanotide nella protoporfiria eritropoietica "where no one has gone

before"

G. Biolcati (Roma)



Translation courtesy of google translation


Afamelanotide in erythropoietic protoporphyria "Where No One Has Gone
before "
G. Biolcati (Rome)
Now if we can just get a copy of the presentation........

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stmccallum
Posted on: Jun 1 2010, 03:57 AM


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Posts: 100

Yes Joe,

I agree, disclose the cost of the implant........
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stmccallum
Posted on: May 30 2010, 01:36 AM


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Posts: 100

Hey Schlitzo

Here are my gripes with Clinuvel

1) Press releases for Italian Approval, they had to have know this was coming they were extremely ineffective at getting the message out to the major news wires, uptake was very delayed at best.

2) Italian presentation did one occur on May 21st if so would be nice to be able to view or download from the clinuvel website.

3) Delays on announcing data when are we going to see the phase III complete data, if there are delays could they at least announce what they are and when we can expect to see the data.

4) The sudden apperance of a host of new derm targets on the website with a message from CEO from a previous interview that they are evaluating an number of other indications but has not disclosed what they are??? Are they working on the IP? What is that status of the studies and what other indications are they proposing to pursue.

Also if they are going to have a place on their website to submit comments or questions. It would be equally helpful if they made some effort to answer the questions submitted. Do we need to show up in person in the Melbourne office or Swiss offices to get their attention???



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stmccallum
Posted on: May 27 2010, 01:56 AM


Group: Member
Posts: 100

Re Italy jumping the gun.
I suspect it was a group of patients and a well connected PI who have participants in the EPP trial and want assurances of continued access. Apply the right amount of pressure and concern that the drug supply needs to be assured and suddenly you have an approval.

I would like to know what price they are paying.....
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stmccallum
Posted on: May 22 2010, 03:51 AM


Group: Member
Posts: 100

Has anyone seen any press releases related to the phase III data that was supposed to be released today??

I can't find anything on the site royco suggested??

Anything on any of the news wires?

http://www.sidemast.org/about-sidemast.php

announcement of italian EPP III results today...
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stmccallum
Posted on: May 21 2010, 06:47 AM


Group: Member
Posts: 100

Apologies for the typo

Melbourne, not Melborne, and I have been there as well so even worse.
Great City, just not in my mind a biotech hub. Maybe I am biased, but the capital required to support these companies is huge and you need a fair number to really have a thriving hub.

Question still applies

Why Melbourne, AUS and not Boston or SF, or Switzerland....
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stmccallum
Posted on: May 21 2010, 04:26 AM


Group: Member
Posts: 100

A question for the board, why did clinuvel set up shop in Melborne AUS?

I don't want to diminsh the value of AUS biotech, but it sure is off the beaten path from where the melanotide story which started at Univ of Arizona, and a long way from most of the capital rich pools of VC dollars, who have a greater tolerance for risk.

Again don't beat me up, just a question in this time of relative calm after a bit of good news but not a lot of traction from the investor community and a real absence of uptake on the news wires. It took over a day for the press release to trickle onto the news wire and even then not the big players.

Now its about the larger investment community understanding the potential and buying interest that will drive the sp.

I am confident the the clinical and regulatory development elements are going in the right direction, awaiting the release that will come with the presentation at the Italian Derm Meeting tomorrow.
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stmccallum
Posted on: May 20 2010, 12:55 PM


Group: Member
Posts: 100

Yeah that would be nice.
Bit surprised there has been only limited press uptake on the approval in Italy.
The press release did not appear to hit AP or Reuters.
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stmccallum
Posted on: May 19 2010, 11:59 PM


Group: Member
Posts: 100

Hey Mr. Smith, greatly appreciate your forcast for sales.
I was thinking about your 150.00 cost, I think you have correctly indicated this as conservative.

Lets look at other injectable agents, given q3-4 months.
Lupron and the related family springs to mind.
They were charging ~1000.00 to 1500.00 for that implant.
Given the very small population, 1500.00 per injection would not be unreasonable.
~6000.00 per year.
Given the innovation, safety, efficacy.

Don't shoot me if you don't agree, I am just thinking about what a range could be for Senesse.

For the cosmetic space for example
One vial (100 units) of botox for cosmetic use, used to cost the physician ~$400.00
in the US market.
It would not be uncommon for the practice to charge the consumer about 550.00 for 50 units
So a bit over 275% mark up but you are paying for the Derms time and expertise as well.


Now you are seeing a price per unit (10-15 dollars / unit) 100 unit vial would thus cost 1500.00


"Population USW (P) = 300,000,000
Psorias (PS) = Px.02 = 6,000,000
Cost © = $150 (Conservative)
Implant p/yr (I) = 6
Shares on offer (S) = 500,000,000 (Some dilution to be expected)
Multiple (M) = 14 (Conservative)
Share Price (SP) = $151.20"
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stmccallum
Posted on: May 19 2010, 03:42 AM


Group: Member
Posts: 100

Just noticed that the Approval press release hit the business wire, today, tues may 19th at 12:10pm EDT.
Was wondering why the approval did not get more widespread coverage.
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stmccallum
Posted on: May 19 2010, 03:42 AM


Group: Member
Posts: 100

Just noticed that the Approval press release hit the business wire, today, tues may 19th at 12:10pm EDT.
Was wondering why the approval did not get more widespread coverage.
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stmccallum
Posted on: May 19 2010, 03:37 AM


Group: Member
Posts: 100

I agree with joe_schmoe
25-50% is more realistic
When the drug is approved the regulatory risk is gone.
This was done without a parnter so they can't expect to paying anything less.
Its then just execution of your launch and sales strategy.
And a strategy for expansion into new indications, which adds value.
A sales force for this would be extremely focused on derms for the initial indication.
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stmccallum
Posted on: May 17 2010, 11:19 PM


Group: Member
Posts: 100

I should follow my own advice to Gordo and due my DD before I post a question.
"Clinuvel is preparing to file for approval of marketing authorisations in Europe through the centralised procedure of the European Medicines Agency (EMA), and will decide the timing of filing pendign the final results of is Phase III European EPP trial (CUV017). Clinuvels objectives are to file in the US through the FDA, subject to further data on safety and efficacy of the drug."

Great news all around.
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stmccallum
Posted on: May 17 2010, 11:07 PM


Group: Member
Posts: 100

Hey theadder,
Wonderful news, great thing to read first thing in the morning.
Wonder if other EU countries will grant approval through reciprocal review agreements?


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stmccallum
Posted on: May 15 2010, 12:20 PM


Group: Member
Posts: 100

Gordo
"If the population is small"??
Do you have any idea how many EPP patients there are in the US, Europe?

There has been very limited study completed on the prevalence of EPP because of its extremely low incidence. Geographic location generally doesn’t seem to bias the incidence of EPP, although one study has suggested that the incidence in Slovenia is 1:58,000. Other studies include incidence that range from 1:75,000 to 1:200,000.

Simple math 350 Million in US 1:200,000 so ~1750 patients in US.

I have no idea what they are going to charge.
It has not been disclosed.

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stmccallum
Posted on: May 15 2010, 03:58 AM


Group: Member
Posts: 100

Gordo
The battles with individual insurance companies that decide to say no for a group of patients who otherwise have
NO other options will occur, on a one by one basis, and yes they do have the ability to say no.
The patient can also take the rejection to an independent arbitrator and request a review.
Additionally the most effective path appears to one of shame and publish and then have a political intervention.

The insurance company is going to weigh the total number of patients (small this is an orphan disease)
against the cost and benefit and make a decision how they would like to proceed.

I think you are going to see very few refuse to offer an effective safe treatment.



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stmccallum
Posted on: May 15 2010, 03:47 AM


Group: Member
Posts: 100

Gordo

What are the other treatment options?
Suggest you read a bit about the condition to understand the limitations this places on one's life
http://www.porphyriafoundation.com/about-p...f-porphyria/EPP



Treatments
Since the main symptom of EPP is photosensitivity, it is important to follow protective measures to decrease damage that might result from light. Sunlight is the first culprit, so an EPP person should avoid the sun according to their personal sensitivity



Be careful with lights. Problems with fluorescent lights are common. Incandescent bulbs are generally acceptable. However, companies may be changing the filaments and thus varying output.

Steps one and two, stay indoors and keep room dark.

I don't know about you but that is not in my mind a great alternative.





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stmccallum
Posted on: May 15 2010, 03:41 AM


Group: Member
Posts: 100

I am not trying to offend anyone here but lets look at this objectively.
If you have EPP you have NO treatment options.....
NONE
You have constraints on your entire life.
From access to education, sporting activities, full employment opportunities.
The list goes on.

NOW if and when a drug is approved that is SAFE and EFFECTIVE at addressing the underlying barriers to the above listed.

Tell me what government or insurance company is going to take the heat of saying no.

They can't say no a cheap generic exists.....

The reimbursment piece here is not the biggest challenge.

Now if only management would give us some output to say what the status of the 1Q reporting of the phase III results.
To my mind first quarter is Jan Feb Mar. We are now in 2Q and June will be on us before we hear anything, and they wonder why investors get tired of missed timelines.
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stmccallum
Posted on: May 11 2010, 10:47 PM


Group: Member
Posts: 100

Yes indeed, nice move yesterday, maybe we will hear some news soon......
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stmccallum
Posted on: May 9 2010, 10:07 PM


Group: Member
Posts: 100

Could not agree more, they consistently exceed expectations on how many more time lines they fail to keep.
As a result the SP tanks again, now below 20 cents.
When are they going to announce the Phase III trial results?
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stmccallum
Posted on: Apr 10 2010, 03:41 AM


Group: Member
Posts: 100

Yes I agree if they can not sustain a sp above 50 cents then they do not deserve to reap any benefits, the last thing I would want to see would be an effort to re-price their options.
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stmccallum
Posted on: Mar 30 2010, 12:15 PM


Group: Member
Posts: 100

Agree but approval of the IND is a major hurdle and will result in more coverage in the US....
FDA is being super conservative these days, as they have experienced bad press on a number of fronts.
Device approvals, oversight of CT scanners.
IND's and NDA's are under intense review.
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stmccallum
Posted on: Mar 30 2010, 11:54 AM


Group: Member
Posts: 100

Finally IND approved.......
Company Announcement
Tuesday 30th March 2010 Melbourne, Australia
FDA allows US clinical trials of afamelanotide in EPP
Phase II trial of novel drug in erythropoietic protoporphyria (EPP) to commence immediately
Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the US Food and Drug Administration (FDA) has agreed for Clinuvel to proceed under its current Investigational New Drug (IND) to conduct a Phase II clinical trial (CUV030) to evaluate afamelanotide as a first-in-class photoprotective drug in patients diagnosed with erythropoietic protoporphyria (EPP).
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stmccallum
Posted on: Mar 11 2010, 11:54 PM


Group: Member
Posts: 100

Thanks for the link Royco.

The Thai translation is this great tool by google translation.

Sorry I did not mean to be offensive.
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stmccallum
Posted on: Mar 11 2010, 08:50 AM


Group: Member
Posts: 100

Royco regarding "a bit of insight in german trading"

สิ่ง ที่ มี เพศ สัมพันธ์

That's Thai for WTF?
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stmccallum
Posted on: Mar 8 2010, 12:53 PM


Group: Member
Posts: 100

RE joe-schmoe's question is this a biologic.

"Afamelanotide is a linear peptide with 13 amino acids. Two amino acids present in α-MSH have been changed and amplified to produce afamelanotide".

Taken directly from Clinuvel website.

This is definitely a biologic, subcutaneous implanted is needed as a peptide would be digested by gastric acid and pancreatic enzymes.
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stmccallum
Posted on: Aug 20 2009, 06:39 AM


Group: Member
Posts: 100

This is a good article to explain some of the selection that occurs. It is possible that the UV treatments triggers endorphins, it is particularly interesting to see how people can select UV emitting beds for the non UV emitting.

http://www.bu.edu/phpbin/news-cms/news/?de...mp;template=226
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stmccallum
Posted on: May 19 2009, 07:21 AM


Group: Member
Posts: 100

I called E-trade about the same thing, they will exchange for ADR's but for a fee, ~30.00 per account then 0.05 cents per share the guy was not exactly sure if it was per new ADR or for shares, I held off at this time and will wait and see, the two should trade near parity in the long run, taking into account the 10:1 difference in the ADRs and common shares.
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stmccallum
Posted on: May 14 2009, 04:01 AM


Group: Member
Posts: 100

Thanks for the reply, I agree CUV has huge potential, I need to do a bit more diversification though, as I have a substantial... portion of my investment portfolio in CUV currently. Re MELA I plan to take profits with the PMA filing and run up to FDA review which is a mear 180 days.
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stmccallum
Posted on: May 13 2009, 11:39 PM


Group: Member
Posts: 100

Agree, won't make it a regular event but was good banter.
Is anyone else following Electrical Optical Sciences (MELA) they have a device that helps Derms and Primary Care Providers better discern what moles are high risk and what are lower risk to help decide which ones to biopsy. They are pending a PMA for their recently completed phase III validation studies.
Happy to take this off-line as it is not CUV specific but in the Derm melanoma area.
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stmccallum
Posted on: May 13 2009, 08:18 AM


Group: Member
Posts: 100

Yes I fully expected a huge debt to treat smokers as well, but when the die they go quickly so the costs attributed are less. Very morbid indeed.
Re smoking I rather like this image

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stmccallum
Posted on: May 13 2009, 04:45 AM


Group: Member
Posts: 100

I guess the workers in the bars and restaurants don't have the right to a safe environment to work in then, or they should just choose to find a bar that does not allow smoking?
I am not attempting to stop anyone from smoking just do it in their own home or where ever they choose, don't expose me to it thanks.

I will be happy to accept their taxes and the net benefit from them living 10 fewer years and transfering the tax wealth to other causes, thanks
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stmccallum
Posted on: May 13 2009, 04:43 AM


Group: Member
Posts: 100

Sorry to burst your bubble but Somkers don't cost more they pay more taxes while alive and live shorter lives so they don't in the long run cost more. The costs only rise if they have a protracted battle at the end.

Smokers die some 10 years earlier than nonsmokers, according to the CDC, and those premature deaths provide a savings to Medicare, Social Security, private pensions and other programs.

Vanderbilt University economist Kip Viscusi studied the net costs of smoking-related spending and savings and found that for every pack of cigarettes smoked, the country reaps a net cost savings of 32 cents.

"It looks unpleasant or ghoulish to look at the cost savings as well as the cost increases and it's not a good thing that smoking kills people," Viscusi said in an interview. "But if you're going to follow this health-cost train all the way, you have to take into account all the effects"

Viscusi worked as a litigation expert for the tobacco industry in lawsuits by states but said that his research, which has been published in peer-reviewed journals, has never been funded by industry.

Other researchers have reached similar conclusions.

A Dutch study published last year in the Public Library of Science Medicine journal said that health care costs for smokers were about $326,000 from age 20 on, compared to about $417,000 for thin and healthy people.

The reason: The thin, healthy people lived much longer.

Willard Manning, a professor of health economics and policy at the University of Chicago's Harris School of Public Policy Studies, was lead author on a paper published two decades ago in the Journal of the American Medical Association that found that, taking into account tobacco taxes in effect at the time, smokers were not a financial burden to society.

The key element is once they get sick they don't last long.
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stmccallum
Posted on: May 7 2009, 10:48 PM


Group: Member
Posts: 100

One point I wanted to respond to, US trials are never cheap unfortunately.

Additionally most companies hedge the expected costs for the entire trial in the local currency before it begins, so they don't have any upleasant surprises at the end of the study.

So the benefits of a rising Australian Dollar relative to USD won't impact much the current studies they could benefit future ones, as you noted in your post.
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stmccallum
Posted on: Mar 19 2009, 01:19 AM


Group: Member
Posts: 100

Hey ad0304 I am not trying to be argumenative either. But I strongly believe that a significant portion of PMLE suffers, suffer with the thought there is nothing they can do but avoid sun exposure or use other supportive care measures to deal with the problem. Many of their primary doctors clearly feel the same way, and will need to be educated about what is available. But once a product with proven benefits is available then the education campaign needs to be in full gear. At that point phase IV trials initiated by Derm investigators will help to build the basis for expanded indications to obviously be supported by well designed RCT done in duplicate to meet FDA requirements.

But don't dump on well planned DTC programs. Informed patients are more likely to be compliant with their treatments, and unfortunately highly informed patients often know more about their treatment options than some of their treating physicians, (my personal opinion).
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stmccallum
Posted on: Mar 18 2009, 12:20 PM


Group: Member
Posts: 100

I will quote you since it appears you are back peddling.
"I think this is a common tactic among pharmaceuticals: find the cure to a disease that people don't know they have, then spend millions on marketing to convince them both that they have it AND they NEED a cure (ie, antidepressants, ED pills, social anxiety, overactive bladder, etc)."
I would assert that you can recoup your investment in R&D and yield a steady and handsome return for investors by concentrating on real diseases, ones that patients independently go to the doctor looking for resolution or improvement of, life threatening on non life threatening. Additionally all the marketing budget in the world is not going to rescue a dud 5th to market me too. In fact you will probably spend more on marketing and sales for a marginal return and have to stoop to off label promotion in an attempt to recoup the R+D spend.

Yes we are a more affluent society and have drugs for conditions that people used to suffer through, and as a whole expect better more compelling safer drugs, and rightfully so, many of them we pay fairly high costs for, so we expect a high return.
But the idea that CUV or any other company can thrive on a creative marketing campaign and a second rate drug or marketing team that is generating "new conditions in the mind of the consumer" is niave.

I have watched and invested in this space for sometime, and personally know some of the princples individuals from the Univ of Arizona who brought and tested Melanotan II, along with a number of key participants from Palatin who saw bremelanotide potential in ED wiped out due to a BP signal.

I want this company to succeed as much as you do, but the basis of approval and acceptance will depend on real science, real value and a real desire for patients to take this drug, and any other compounds clinuvel makes.

The fact that all 14 of the early patients in the EPP trial wanted to continue to use afamelanotide on a compassionate use basis, and the narratives that they will provide to accompany the NDA, and MMA files will speak volumes to the regulators and advisory boards that will review the science and efficacy of this compound.
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stmccallum
Posted on: Mar 17 2009, 01:47 AM


Group: Member
Posts: 100

Re Melanotan II and bremelanotide.
Do you have a reference to the bioequivalence or lack of, for these two compounds, along with the overall rates of hypertension, cancer and heart problems reported as adverse events and serious adverse events?
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stmccallum
Posted on: Mar 17 2009, 01:29 AM


Group: Member
Posts: 100

ad0304 before you dismiss Clinuvel's estimates of PMLE and their other targeted conditions.

I am going to call you out on a few of the conditions you noted in your post. Take OAB and ED and the other diseases where you firmly believe pharmaceutical companies have found a cure and are now onto phase II dupe the consumer into thinking they have it so they can sell them a new drug. I would suggest that you look at some data before you make such generalizations.

Point in example, OAB

Kimberly Clark was quoted in a Nonwovens Industry (March 2001) article projecting that in the year 2005, the U. S. retail and institutional sales of the manufacturer would reach $2.1 billion and global sales would hit $5.8 billion. Kimberly Clark is believed to have approximately half of the market (in 2001, its share of the adult incontinence market was 52.4%).
Can you really say that adults are buying diapers because of a clever marketing campaign has duped them into thinking they need them, and this dollar estimate does not address one dollar spend on any pharmaceutical agent for OAB.

As for ED well there must be alot of simple minded men who think they are impotent when they truly are not, as Viagra's sucess appears to speaks for itself.

Regarding Depression, and the other made up conditions, possibly you need to look at the market share for the SSRIs, or is this too just a tremendous marketing success.

What I don't understand is given your outlook on the entire pharma industry and their inability to estimate market opportunities then why invest in any company in this space let alone Clinuvel?
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