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alm it could go 7=4 leaving a question mark for the FDA in December which would leave the stock price in single digits before FDA approval.This is the FDA your dealing with .Woodcock is probably on her way out and all she needs to do is say NO to expansion and take amrn down for a a two year legal battle.
Barb great you are going to Adcom,it will make a huge difference to have as many on amrn side on the day.I think last time it was 9-2 against lets hope we can reverse it 9-2 for V
Great to have you at adcom Zip
Jl I just went back on nthe board last night and heard about you intense week in Hospital.Speedy recovery.Hope you got to see Rory take down Koepa for 16 million purse.
Whal you must be having a ball with this slide and all longs nervous .just try not to show it
WRONG MELL.I have a huge amount of my money invested in AMRN and I believe in the drug.I want the ceo JT to make my money work and when a problem arises then I want the legal team to work on it.I dont want someone on a message board to be harassing the only person that makes a final decision on my investment.He can loose his own money but I dont want him fcuking with my money.See what she did with SRPT? Everyone in the FDA including her scientists told her not to give srpt the ok and she gave it the thumbs up.She is the boss.If you asked her a song to sum up her relationship with Bio she would say Eurythmics Thorn in my side.I like Bio but-----
Bio you have to stop being in contact with woodcock or we will all loose our money.See how she went against everyone and gave Srpt the OK for their drug.She is the boss and still is and probably more dangerous now .She can take Amarin down.Leave her alone let Amarin deal with her ,they know how she works since 2013 battle.
Larry I believe we need people on V to be present at the Adcom to give Amrn confidence and the panel to think twice when they see the following amrn have
The last company Adcom I went through out from 2013 was Elan and at the end they thanked all the patients who travelled with serious MS problems for making the journey.It does make a difference.
JF thanks for the healthy cocktail recipe.Can you drive after it?
Cant believe you got into this pos?I saw this on friday also but didnt go near it.I hope you didnt loose your ass on it.Get back to Amrn
Ruthless FDA
CAMBRIDGE, Mass., Aug. 19, 2019 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.
The CRL generally cites two concerns: the risk of infections related to intravenous infusion ports and renal toxicity seen in pre-clinical models of golodirsen and observed following administration of other antisense oligonucleotides. Renal toxicity with golodirsen was observed in pre-clinical models at doses that were ten-fold higher than the dose used in clinical studies. Renal toxicity was not observed in Study 4053-101, on which the application for golodirsen was based.
“We are very surprised to have received the complete response letter this afternoon. Over the entire course of its review, the Agency did not raise any issues suggesting the non-approvability of golodirsen, including the issues that formed the basis of the complete response letter,” said Doug Ingram, president and chief executive officer, Sarepta. “We will work with the Division to address the issues raised in the letter and, to the fullest extent possible, find an expeditious pathway forward for the approval of golodirsen. We know that the patient community is waiting
Amarin mistake.I think they should have waited going to war with DS /Itc/Fda to get drugs banned.The big guys in DS would loose billions so they had to make a call to people in the FDA to create as many problems as possible.At the end of the day the final decision will be with the FDA.If they say no? well the stock crashes the legal teams move in to stay in the courts for years and if Amarin win in 2022 well pretty much game over for the stock.If the adcom room and hallways are full of patients nobody needs to say anything ,the atmosphere in the room will be 100% behind Amarin.They need all the help they can get ,its not going to be plain sailing Nov 14.The FDA will not want another defeat .
Cheers
Good info whal.Just did google search.Im prone to a few chest infections and dont like taking antibiotics so may try this.Do you get it in a health store.
WHAL there you go building profiles so you can see everyones pain on Nov 14.Very sad
Nice to see you so positive as usual
IBB up 2% lets break $15
Thanks Raf
JF i think its in cancer therapy area.Should say on yahoo finance.Funny watching and listening on stockwits.Nice break from amrn high every day for 30 minutes and then the rollercoaster ride down .
Didnt buy it just kidding but saw it with first halt at $9 and its been halted 4 times already.Average vol 13000 and 6 million today.Criminals at work @ pstv but would be great to see amrn do the same nov14 th
sold all my amrn and bought pstv yesterday at 2.94
Sorry to hear of your mums passing.
Buyback?Are you crazy .Kennedy is delighted all the share options he is going to get after this crash.
?? 99% on this board haven’t slept since last Thursday
JL sorry for your loss
Really Whale.Guy has 4 gins and your trying to find out how upset he is .Your other messages about who feels fear now and you hope it goes back to pre Christmas prices .We know what you want from Santa ?Single digits and Santa to show you everybody’s pain .You seem like a nice guy but you need to see someone about those thoughts of people’s pain .Maybe a dom mistress
Bio Good to see you back
BUS I think jeffries question about V interaction problem with statins at the 7pm conference call really upset JT. Im not sure why Jeffries or where they heard the rumour.JT didnt think it deserved an answer.NEXT
North great to have you on board for Adcom if we can get the volume going.We need people like CAPT from stockwits as he is a walking miracle and he is well over 6ft tall and can probably beat the whole panel up if it goes negative.Imagine if people tell their story and introduce how far they travelled to get to the Adcom .
LOL.I think Bio would be great in being one of the top organizers putting his energy in a positive way.
Zip if we could get the adcom room full of patients and the panel know that they took planes trains and automobiles to get there because of their belief in V it will make a huge difference to votes .Another stock i was in called Elan[ms drug tysabri] had an adcom and investors paid for the patients mostly in wheel chairs expenses and they packed the room and also spoke.It was a win win situation,We need to start a fund for those who cant afford to get to adcom and as many people who can afford to pay their omn way.
15$ on investorshub.Hope its not the usual crap of the shorts letting it go high pre market but taking it way down at the open.I think JT and the underwriters who got their clients half a billion dollars are being put under pressure to see $18 again.I didnt think GS would be putting a target on Amrn until after expansion but now their clients money are at such a dangerous level with 32 million shots they have to pull the trigger SOON
why is Nasdaq pre market showing a high of 14.95 on small volume?
Now Whal leave rose alone.Your back building profile lol
BIO i think you are the only person out of the millions of Amrn investors that thinks Sept 28th fda expansion is still on BECAUSE Adcom is in November.You have the cart before the horse on this one.Time to let it go and let Amrn horses take the lead.I know you feel very emotional BUT
I think they have address on their website and its across from fitz sq but they have a new guy working ireland who was at the AGM but hes only part time so maybe they changed again.
Kev
Amrn moves last year from ballsbridge to pembroke bust beside Fitz Sq
Bio you have done a great job on the board and worked endlessly.But you are a thorn in her side and she never gave you you any info over the years but just one liner replies.Let Amrn work wouldcock.best of luck in the future
Great post Bubb