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post Posted: Jun 22 2018, 10:24 PM
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In Reply To: xray's post @ Jun 22 2018, 05:59 PM

Seems to me that a failure / refusal to file notice based on efficacy would warrant a halt and require a delay to get the communication right. That would be “regarding a regulatory submission”

Such refuse-to-file (RTF) actions are regulatory tools to prevent multiple-cycle reviews of deficient applications, which can be time-consuming, costly, and unnecessary.1

However, the number of RTF actions has been increasing over the years, with each incident affecting both the FDA and the applicant in different yet considerable ways. To clarify the agency’s basis for determining the completeness of an application, the FDA has drafted new guidance on circumstances that may lead to RTF action.2 Specifically, RTF action is concerned in circumstances where there are complex and significant deficiencies in the following aspects: 3

When an application is materially deficient or disorganized;
When there is information lacking on any one of the disease indications;
When the FDA specifies the need for more than one clinical trial, yet the applicant relies on only one;
When there is a lack of assessment of studies on potential abuse of the drug;
When the FDA specifies the need for an electronic submission, yet the applicant fails to provide one;
When the applicant fails to submit the agreed-upon additional minor components within a 30-day window (discussed below).

Pucker up smile.gif

post Posted: Jun 22 2018, 09:58 PM
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In Reply To: macgyver's post @ Jun 22 2018, 09:54 PM

Couldnt they just announce the announcement on monday? I really hope we will get an update when the US market opens. Otherwise we are left to speculate the whole Weekend

CLINUVEL's SCENESSE Potential: 1.)EPP 2.)Vitiligo 3.)SUN Protection and skin cancer prevention
post Posted: Jun 22 2018, 09:54 PM
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In Reply To: BIG BLUE NATION's post @ Jun 22 2018, 09:29 PM

Correct, we’ve had many delays before without the need for trading halts. And $3 has been knocked off the share price over the last two weeks already so I don’t think Clinuvel would think it necessary to initiate a trading halt for a delayed submission. It has to be news that is positive (NDA submission accepted) OR really fantastic news (approved already🤣)

post Posted: Jun 22 2018, 09:29 PM
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In Reply To: Farleap11's post @ Jun 22 2018, 03:59 PM

I think your onto something there ........ it shouldn’t be as simple as we submitted the NDA......also
It shouldn’t be as simple as / we didn’t dot our I and cross our T the fda wants us to re write a few things
meaning ANOTHER delay ........ Lord knows we have had plenty of delays without a halt .

So a two fold announcement makes since ........ in the memo it says has something to do with submission m
So that’s one item ....... 2 Nd item ....... take over ....... new product ...... in conjunction with vitiligo ????
All would seem to be positive ......... but then why the downward trend the last few weeks resulting in losing
A couple bucks on the SP?

So many questions ....... all we can do is guess and keep our fingers crossed u til the beginning of the week
Nothing seems to make much since which sadly is status quo for our little investment here .

Personally I think it’s more negative news ........ but nothing that will bankrupt your little gold mine .....
another mere set back in a long list of delays .

Either way GLTA keep the faith ......... we will be dancing in the streets one day ...... be it the beginning of next week
Or at a later date , hang in there gang 😜


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post Posted: Jun 22 2018, 07:11 PM
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In Reply To: xray's post @ Jun 22 2018, 06:41 PM

You are somebody who is far over his frustration limit ;-)

post Posted: Jun 22 2018, 06:41 PM
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I have been posting hear as Xray and Ignoramus for so long that sometimes I forget who I am.
(I really need to get back on my meds again)
Am I positive or negative?
A bear or a bull?
A man or a muppet?
AC or DC?
But at night, when all the world's asleep
The questions run so deep
For such a simple man
Won't you please tell me what we've learned
I know it sounds absurd
Please tell me who I am, who I am, who I am, who I am....



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post Posted: Jun 22 2018, 05:59 PM
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In Reply To: mrdax's post @ Jun 22 2018, 04:53 PM

All I will say is that the announcement better be F%$#king awesome.
You do not pull a trading halt simply to inform people that you have submitted an NDA.
My bet is a Takeover offer congruent to NDA submission.
Suck it.

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post Posted: Jun 22 2018, 04:53 PM
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In Reply To: Johnny H's post @ Jun 22 2018, 03:49 PM

1. checking the notice period of my working contract devilsmiley.gif

post Posted: Jun 22 2018, 04:34 PM
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In Reply To: Johnny H's post @ Jun 22 2018, 03:40 PM

If we agree on what the news is to be (positive), then I disagree with the idea this halt is necessary. Every traded public company deals with this at least 4 times a year, and all the lawyers and accountants. Quarterly reports are far more impactful. Who anywhere is going to be surprised they will announce positive news when they pre announced it 5 weeks ago. This trading halt isn't just unnecessary, it violates the listing rules. It's unprecedented with drug companies and NDAs.

So, I do think they are capable of a marketing stunt, or this is a different situation altogether. And if it is just what we hope for, then it's irresponsible application of the trading halt rules.

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post Posted: Jun 22 2018, 04:25 PM
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In Reply To: Johnny H's post @ Jun 22 2018, 03:49 PM

8. Debt settlement
9. Is there room for my family in my mother’s appartment ?
10. How old do the kids need to be to legally work ?

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