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Incorrect. FDA declined approval. Next try. 5 years. Hello
Not gonna work here. Danish company. Not here. Just a pump and dump. Over and done. Next
Update. Their new drug can cure constipation. Yes!
Fake news flip flop
Russian strong lol
Russian fake lol. Bullish yesterday?
I don’t know about that and even if that is the case with so many dumping you got a long way to wait. AMC is in the middle of a gamma squeeze and then all hell will break loose when HF’s have to cover their naked shorting. No need to wait here with tied up money. You Can make up the losses in another stock
That shot up 50 cents fast
There will need to be a lot of covering on massive short positions.
Everyone here should just sell even at a loss and go buy AMC. YOU WILL MAKE UP YOUR LOSSES IN 2 days.
Yea but no one is paying for this stock atm or anytime soon
Like you said:
The news was bad no matter how you look at it. I almost bought in yesterday but thank god I didn’t.
Agreed...but you have to admit, it's been a good play off this morning's lows.
Like the shorts learned from AMC??? Uhmmm they look like they trying to Ape this.
Very simple. If you have a great drug to help improve and FDA approves. Good. This drug did NOT get approval. Failed. Bad. No hype from APES going to move it. Sorry. Learn from this
I just did a Twitter search of $ORPH and that came up … do your own DD
What does that have to do with ORPH?
Glad I sold yesterday at $17.50...wow.
Reading Stocktwits … seems like they are trying to get Reddit turn this into a meme stock to rekt the shorts. Something about 0 shares left at 138% fee. Going to be interesting at bell.
You hear it but more powerful companies drive this then jump in and buy out then all of a sudden they get approved
Yeah big pharma
It is what it is reason I don’t quit my day job but this one everything you read the approval was imminent fda has different set of rules for different companies
Very true … it’s weird how the premarket chart looks though. Could have a small pop at opening then back down?? Might be enough to get out even for some. Definitely feel sorry for those who bought the top though. Although if in it for the long haul it will eventually pan out just take longer than expected.
Yeah had moderna and did well but now …. Ugh !
Most dishonest people run this country fda is part of it and hedge funds drive it
Yeah I had a feeling early 2021 after election to run until Fall and enjoy summer but no
Same they wait to just push along so they can steal investors money by not being transparent
Yeah ruined my 2020 gains entirely
I feel like the whole market has been manipulate since Biden came in you can only jump on meme stocks feel like there is a massive crash eventually coming and the numbers are all pretend this one stings
Is GLTO not related somehow to orph? I would have expected GLTO to tank as well...
I feel sorry for all of you
read my post #183,,
told you yesterday to get out,,Orphazyme A/S : Asked by FDA for More Data on Genetic Disorder Drug; Revises 2021 Outlook; Shares Fall Pre-Bell
06/18/2021 | 05:15am EDT
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(MT Newswires) -- Orphazyme A/S (ORPH) said Friday the US Food and Drug Administration is asking for more data on the company's new drug application for arimoclomol, an investigational treatment for Niemann-Pick disease type C, a rare and progressive genetic disorder.
In a letter from the FDA, the regulator is seeking more qualitative and quantitative data to support the validity and interpretation of the five-domain NPC Clinical Severity Scale, which the company used in a phase 2/3 study to measure its primary endpoint of progression in disease severity.
The regulator is also asking for additional data beyond the phase 2/3 study to strengthen the confirmatory evidence and support the benefit-risk assessment of the new drug application.
In a statement, Orphazyme Chief Executive Christophe Bourdon said the company will focus on the European approval of the drug candidate while "assessing the potential path forward in the US." They expect an opinion from the European regulator's Committee for Medicinal Products for Human Use in Q4, with a potential market approval in the region by Q1 2022.
"In the short-term, we will need to reduce our costs substantially and freeze all company efforts not related to clinical and regulatory activities to support approval for [Niemann-Pick disease type C]," Bourdon said.
In connection with this, Orphazyme said it now expects 2021 operating expenses of 700 million Danish kroner ($112.1 million) to 800 million kroner, down from the previous range of 800 million kroner to 850 million kroner. Operating loss for the year is now pegged at 670 million kroner to 700 million kroner, compared with the previous outlook of a loss of 100 million kroner to 150 million kroner, according to the statement.
Cash position at the end of the year is now projected to be about 50 million kroner, down from the prior outlook of 350 million kroner.
Orphazyme stock fell more than 55% ahead of Friday's market open.
Price: 14.56, Change: -1.65, Percent Change: -10.18
© MT Newswires 2021
Looks like Europe approval will be next step, They are less strict than FDA. That is scheduled in 4th qtr., or about 3 mths.away. Company says sales most likely 1st qtr. 2022. See you in October.
Rejected or not...killed the company
FDA rejected drug. Down 75% in Denmark. Looks like poor guy who bought at $77.00 is really sick this morning
What a scam
...tsk tsk if you didn't close your ORPH positions yesterday.....
What were they pumping?
Oh well use this as a lesson nothing is guaranteed no matter how "bullish" the rumors and everyone on social media is pumping ... this sucks :(
it's been volatile all day nice intraday swings
For those in the know about college football, Ara lost three grandchildren to the Niemann disease. He set up a foundation to find a cure/remedy and I'm hoping this is given a chance, even if a P4 were needed. I'm not sure any other drug is within 12-18 months from FDA consideration.
Tell me the buys are coming from Denmark and you might have a story.
After the Biogen/Ad decision by the FDA, it should approve ORPH's drug ... but only if the system were not corrupt.
But. Light AH trading. Steady but. Light
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