I took 190 @ 21.5 ..last time i lost around 5000CAD. that was a horrible mistake i have took as i sold when it goes down.
this time i did not sell and i am still holding.. your idea gave me some life as i dont want to lose another 5000 again..
have faith and hope towards your idea and suggestion ..
wolflove77
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today the FDA decline the approval that's why the price went down
anjusheikh
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@wolflove77, what are the chances to get approve by FDA?
wolflove77
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The Copenhagen company said it received a complete response letter from the FDA indicating that the agency wouldn't approve the application in its current form,
Orphazyme said the FDA requested more qualitative and quantitative evidence to substantiate the validity and interpretation of the five-domain NPC clinical severity scale, a disease-specific, clinician-reported outcome measure of disease severity and progression, particularly the swallow domain.
The company said the FDA also asked for more data to bolster confirmatory evidence beyond the single Phase 2/3 clinical trial to support the benefit-risk assessment of the application.
Orphazyme said it is assessing the potential path forward in the U.S. in partnership with the FDA, adding that it plans to cut costs substantially and freeze all efforts not related to clinical and regulatory activities to support approval for NPC.
The company said it will focus its efforts on pursuing European regulatory approval, with an opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use expected by the end of the year and potential marketing authorization in the first quarter of 2022.
@anjusheikh, well if u wanna invest for a long term that's the best opportunity u buy and hold until they got the approval but if u wanna make quick profits i don't think it's a good idea right now ORPH is in downtrend and it will move only sideways until there will some news to get more buying power volume. i hope i ve been helpfull
markkentley86
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Hi Wolf, do you think ORPH has a chance to run up tomorrow? Also what time does the decision come out at tomorrow? thank you
wolflove77
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@markkentley86, yes big chances to make big moves tomorrow if they don't halt it again or shorten it like they did last Friday. About the decision of FDA approval it gonna be this friday june 18
markkentley86
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@wolflove77, Hi Wolf thanks for commenting back, that's good to hear as I bought another 1500 shares before the aftermarket closed today. I thought the FDA approval meeting is tomorrow, not Friday? did I get it wrong or saw something different perhaps?
wolflove77
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@markkentley86, no problem thanks for the tips about the FDA approval i thought it gonna be Friday and good luck
this time i did not sell and i am still holding.. your idea gave me some life as i dont want to lose another 5000 again..
have faith and hope towards your idea and suggestion ..