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CUV, CLINUVEL PHARMACEUTICALS LIMITED
Hamster72
post Posted: Apr 30 2019, 09:40 AM
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In Reply To: Verharven's post @ Apr 30 2019, 09:38 AM

Looks like a real positive number. Let's keep the 30-40% YOY growth and the stock is priced low just for Europe. Add in FDA approval and we are a quick double before the real growth hits in 2020-2021.





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Dr Wally is not a doctor at all. He's a dentist.

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Verharven
post Posted: Apr 30 2019, 09:38 AM
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Quarterly out. $5.9M in receipts - up 70% from the corresponding March quarter last year. $45M cash in the bank
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Attached File  Announcements.pdf ( 215.62K ) Number of downloads: 93

 



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sharelooker
post Posted: Apr 30 2019, 09:36 AM
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Quarterly is out!

https://www.asx.com.au/asxpdf/20190430/pdf/...nn33nhvly80.pdf


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waz
post Posted: Apr 30 2019, 08:54 AM
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In Reply To: LevelHeaded2000's post @ Apr 29 2019, 04:05 PM

Could be. Aussie Bulls says back on track but hey what do they know.

https://www.aussiebulls.com/SignalPage.aspx...p;Ticker=CUV.AX



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PunkassDerm
post Posted: Apr 29 2019, 10:27 PM
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One more, posted directly on FDA.gov
It appears focus on orphan diseases


https://www.fda.gov/news-events/fda-voices-...american-public



2018: A Year of Innovation, Efficiency, and New Advances in Drug Therapy for the American Public
By: Janet Woodcock, M.D.

The beginning of a new year is a good opportunity to look back over the past year and see how all the valuable work done at FDA's Center for Drug Evaluation and Research (CDER) results in bringing important new drug therapies to patients in need. It is particularly clear that our work is about people—and advancing patient care and public health.

In 2018, we approved many new drugs never before marketed in the United States, known as "novel" drugs, along with a wide variety of approvals of drugs already on the market to put to new and innovative uses. Many of these new approvals will have a significant impact on improving—and indeed, saving—countless patients' lives.

This past year was important for meeting the critical needs of people suffering from rare diseases who will benefit from these advances. Among many new orphan therapies, in 2018 CDER approved the first drug to treat patients with a rare, inherited form of rickets, a condition that leads to impaired bone growth and development. Also, CDER approved the first orally-administered drug to treat Fabry disease, a rare and serious disorder that can cause many adverse symptoms, including pain and burning in the hands and feet, and damage to the kidneys and heart. We also approved a new drug to treat patients with phenylketonuria, a rare dietary condition in which patients are born with an inability to break down protein-containing foods and certain sweeteners, and which can lead to brain and nerve damage.

Many of CDER's other 2018 approvals will provide hope, relief, and enhanced quality of life for patients in need:

CDER approved the first drug ever to treat smallpox, the first of a new class of drugs to treat patients with HIV-1 infection who have failed other therapies, and a new single dose treatment for influenza (flu).
CDER approved a new drug to treat seizures in patients with the rare and severe forms of epilepsy Lennox-Gastaut syndrome and Dravet syndrome, and a second drug to treat seizures in patients with Dravet syndrome. Previously there had been no FDA-approved therapy for Dravet syndrome. We approved three new drugs—all in a new drug class—to treat patients with migraines. Additionally, CDER approved the first therapy to treat multiple sclerosis in children.
We approved new advances for certain patients with breast cancer, prostate cancer, lung cancer, and thyroid cancer. We also approved a variety of new drug therapies to treat blood cancers and other blood disorders such as acute myeloid leukemia (a type of blood cancer), and classical Hodgkin lymphoma (a type of cancer of a part of the immune system called the lymphatic system); and thrombocytopenia (a deficiency of platelets in the blood) in patients with chronic liver disease scheduled to undergo a medical or dental procedure.
We also approved seven new biosimilars, which will further help to create competition, increase patient access, and potentially reduce the cost of important biological drug therapies.
Of course, even the best drug therapies are of no use to patients if they are stuck in the approval process. I want to recognize the importance of the efficiencies with which we brought these new therapies to approval.

Under the Prescription Drug User Fee Act (PDUFA), drug developers are assessed user fees that provide FDA with the additional resources needed to maintain an efficient and effective review process. PDUFA includes goal dates for application review agreed to with the pharmaceutical industry and approved by Congress. In 2018, CDER met its PDUFA goal dates for 100 percent of the novel drugs approved (59 of 59).
We use four specific regulatory tools to ensure prompt and efficient expedited review for approval decisions: Fast Track, Breakthrough, Accelerated Approval, and Priority Review. Each serves a purpose in helping to speed a drug’s development or review. In 2018, 73 percent of CDER’s novel drug approvals (43 of 59) were designated in one or more of these expedited review categories. These innovative approval methods can bring a therapy to patients months or even years sooner than if their application went through the standard review process.

In 2018, CDER approved 95 percent of its novel drug approvals (56 of 59) on the first cycle. A "cycle" is the time from when CDER accepts an application for a new drug until we decide about whether or not to approve it. A typical cycle generally takes somewhere between six months to a year, but sometimes things can go wrong. For instance, miscommunication, omissions of important data, and other issues in these complex applications, can lengthen the time it takes to complete a review and may also result in the need for a second cycle, further delaying access to the drug for patients in need. From 2011 through 2017, CDER approved 250 novel drugs, of which 205 (82 percent) were approved on the first cycle. Our consistently high first cycle approval rate reflects CDER’s commitment to working closely with applicants as they design their studies and build their application data. It also reflects our efficiency in getting new therapies to patients as quickly as possible.

Although regulatory processes differ widely between FDA and those of regulatory agencies in other countries, 42 of the 59 novel drugs approved in 2018 (71 percent) were approved in the United States before receiving approval in any other country.


More details about CDER’s new drug therapy approvals—including many specific examples of notable new approvals for the year—are available in our annual New Drug Therapy Approvals report.

I am proud to be part of a team of dedicated professionals who work tirelessly to find innovative, efficient, and, most importantly, safe ways to bring new therapies to patients as quickly as possible.



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LevelHeaded2000
post Posted: Apr 29 2019, 04:05 PM
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Did the shorters finally realize they were making a financially disasterous mistake and are now buying up the stock before they end up in financial ruin?


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PunkassDerm
post Posted: Apr 29 2019, 01:07 PM
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In Reply To: Verharven's post @ Apr 29 2019, 12:56 PM

Some stats on 2018...any day now????


http://eyeonfda.com/2018/03/pdufa-dates-ad...ls-2018-so-far/


PDUFA Dates, AdComms and Approvals – 2018 So Far
Posted on March 14, 2018 by Mark Senak


There would seem to be a momentum for new approvals brought on by a number of circumstances, not the least of which is the fact that last year saw a record number (47) of approvals for new molecular entities (NMEs), but also for generic approvals (1027). And among those approvals, there were a number of “firsts” – such as first gene therapy and the first CAR-T therapies. In addition there were a significant number of approvals in oncology. A lot happened last year. That means a lot of eyes turn to this year to see what kind of year it is going to be in 2018.

So how are we doing? There are a few places to look when you are making that assessment that are kind of surrogate markers to tell us how things are going. First, of course, there would be the NME approvals. By the end of February this year, FDA had approved only 4 NMEs, which might sound discouraging, but in fact, it is only one less than was approved by the same time last year. There is still a lot of time for a lot to happen in 2018.

Another place to look is at PDUFA dates, and in doing so there is perhaps reason for cheer. During January and February there were 15 PDUFA dates, 3 of which resulted in Complete Response Letters and 12 of which were approvals, some of which not only occurred early, but very early. At least three of these were approved in December 2017, two months before the PDUFA date. Of the approvals during the first two months, 9 of them were NDAs and 6 were sNDAs.

And finally, if we take into consideration the activity among advisory committees – last year there was only 1 advisory committee meeting held during the January/February period to consider an NDA for a new drug. During the entire year by my count there were 23 such meetings. By contrast, during the January/February time period this year there were 5 advisory committee meetings held to consider NDAs and there have been 10 meetings scheduled so far this year, with more surely to come, particularly with the increase of drugs that have priority review.

Back to PDUFA, for the future, right now by my count, I am currently counting 60 more decision dates for 2018, 41 of which are for NDAs and the balance are sNDAs, and of course, there are more to come. Five of these involve product NDAs in oncology, two of which FDA have already acted upon away before their actual PDUFA dates. There are also five in cardiovascular, two in antimicrobial and six in pain.

In short, at this early juncture, judging by a look at these “surrogate endpoints” it would seem that there is a good chance this year will not be a slacker in terms of progress in approvals overall or in advances in major disease areas.


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Verharven
post Posted: Apr 29 2019, 12:56 PM
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In Reply To: Hamster72's post @ Apr 29 2019, 12:48 PM

A nice article on FDA approval times http://www.pharmexec.com/how-fast-are-fda-fast-lanes for drugs given the 'fast lane' designation under 4 different types of programs so includes priority review which is what Scenesse has. Point of note is that even though the PDUFA date is given as 8 months from the submission date for a PR (so 6 months once the day 74 letter has been generated which we got in Jan) this isn't set in stone and the second graph (Figure 2) I've copied below is the one of interest showing the median time of approval for Priority Review (PR - in green) is about 240 days (8 months) which is bang on the expected timeframe, but there is a range of about 90 days to 620 days though maybe a trend for this getting into a narrower band for all approvals with each year especially now in 2018/2019 with the push for even faster approvals..



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Hamster72
post Posted: Apr 29 2019, 12:48 PM
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I'm a novice on FDA approval timelines. Can anyone with knowledge help us understand expectations on a FDA decision? Would it be normal to not receive an answer until July, or is it probable we will hear a final decision before? Also, is it a positive that we are still here 60 days out without a decision or Clinuvel withdrawal, or is this all completely normal?

Thank you in advance.



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Dr Wally is not a doctor at all. He's a dentist.
 
Dr Wally
post Posted: Apr 28 2019, 11:47 PM
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In Reply To: Dr Wally's post @ Apr 28 2019, 07:52 PM


ironically might make more sense 🤓

 
 


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