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CUV, CLINUVEL PHARMACEUTICALS LIMITED
seeva222
post Posted: May 29 2019, 03:57 AM
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In Reply To: Desert Rat's post @ May 29 2019, 03:45 AM

What is the data on early approvals? Ie What % come early? How many days?

Someone had it. Tx

 
Justinian
post Posted: May 29 2019, 03:55 AM
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In Reply To: Desert Rat's post @ May 29 2019, 03:45 AM

Bremelanotide phase 3 trial lasted 32 weeks in 700 patients. Scenesse has been tested in hundreds of patients now for years. While it hasn't been tested in in the same number of patients (700+) for several years or more, from my semi-limited experience with a few different drug types this type of safety data is way more than normal at the time of approval.

What do you mean by CMC?
https://clinicaltrials.gov/ct2/show/NCT02338960

 
Desert Rat
post Posted: May 29 2019, 03:45 AM
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CLVY 54,000 shares traded so far today (Wed 1:30 EST) in the US. Listened to the AMAG Pharma Analyst Day conference webcast last week which updated on bremelanotide (Vyleesi). They stated they are currently in labeling discussions with the FDA and that the results from the FDA-requested ambulatory blood pressure monitoring study in frequent Vyleesi users was "in line with previous data". They were pressed for more specifics but appropriately deferred to FDA confidentiality, esp. as the June 23rd PDUFA nears. They also had a Vyleesi patient present a gushing description of her personal experience on one the two (n=600 each) phase III trials, which although an anecdote, was rather convincing. One can reasonably conclude that the Vleesi NDA is on track for a positive decision in 3 weeks. One curious "mistake" in the AMAG presentation was a statement (from an MD) about "selectivity" of brem for MC4 receptors, which we all know is not true: it is a non-specific melanotropin agonist, like afamelanotide. Nonetheless, a clean approval for Vyleesi should augur well for Scenesse as there is so much more data for the latter in terms of safety and efficacy, including no CNS effects. Unless there are serious CMC issues with Scenesse, I'm expecting a positive decision a week or so before the July 8 PDUFA date. GLTA


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the near future
post Posted: May 29 2019, 02:52 AM
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In Reply To: rabbitrun's post @ May 29 2019, 02:46 AM

We are here since long time my friend
And if I am not wrong , have close number of shares to you

 
the near future
post Posted: May 29 2019, 02:50 AM
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In Reply To: seeva222's post @ May 29 2019, 02:24 AM

Hope not mate

 
rabbitrun
post Posted: May 29 2019, 02:46 AM
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In Reply To: seeva222's post @ May 29 2019, 02:24 AM

Agreed. Still no fat lady singing.

 

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seeva222
post Posted: May 29 2019, 02:24 AM
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In Reply To: BIG BLUE NATION's post @ May 29 2019, 02:05 AM

Last time we had these discussions the stock tanked


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BIG BLUE NATION
post Posted: May 29 2019, 02:05 AM
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In Reply To: Dr Wally's post @ May 28 2019, 07:51 PM

Certainly take some profits upon FDA approval if u need them, or just want to enjoy the sweet success
of having a long term investment pay off .

Everyone needs to start thinking about a exit strategy , or a little profit taking .

Do so wisely however , I would hate to be the guy / gal that sold out COMPLETELY at $35-40 a share USA
to watch the stock hit $75 or so a year later and anywhere between $100-$200 3 years or so down the road .

Can you imagine of having owned Qualcom , Apple , Sony or some of the other big money makers that u had bought at bargain basement
prices ....... sold when it reached $40 or so ......... to know see the stocks at $400 plus😳

Everyone is in a different boat , has different amount shares , different time frame to do something with
the nice returns we will all be seeing ........ plan wisely .

People don’t plan to fail ...... they fail to plan. Don’t be to greedy , enjoy the rewards .

Just realize FDA approval is only the beginning....... depending on shares each individual has , there could be
Generational type money to be made here ....... in etc ...... you make enough to live your dreams , pass along the oefrovers
to your next generation.

Exciting times are ahead ........ GLTA



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[color="#0000ff"]BBN[/color]

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the near future
post Posted: May 29 2019, 01:57 AM
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In Reply To: Dr Wally's post @ May 28 2019, 07:51 PM

True true true
I can not beleive that we reached this level
I was always saying Sp of 50 in 2020
I said I will sell gradually in 2020
I might sell something before
Have my shares since 10 years, unbeleivable journey
I should enjoy the money and the profit
He was right, it paid off at the end
Happy investor


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seeva222
post Posted: May 29 2019, 01:08 AM
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I remember fretting over $5 prices.

 
 


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