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Take a peek at ARRY news today... NDA withdrawn, gonna be ugly over there tomorrow
Well, guess we don't have to wait for the 29th after all...
Hey! Wake up, people!
Bini AdComm scheduled for afternoon of March 29. Should be interesting. They are specifically going to discuss the prior checkpoint inhibitor patient data.
https://www.fda.gov/AdvisoryCommittees/Calendar/ucm547160.htm
I've got a buy order in at 7 also. Hope it fills! ????
Excellent! Hope it gets whacked big time tomorrow, I've got cash waiting. (In reality, probably won't dip too much, this offering will be hugely oversubscribed...). We need more details
I heart this post
Got it, thanks for the clarification. One of EMA's great strengths (relative to FDA) is transparency. Once they file, expect 5 to 7 months before CHMP recommendation and up to 2 additional months before EC approval. Maybe a little faster if they have orphan drug status or they can convince the agency to give conditional approval. We should be able to follow along on the EMA website as the meetings happen and the agendas are published.
But nothing happens until they file the MAA, and according to their 1/7/17 PR, we should expect that in 2H17.
Anyway, looking forward to Tuesday and any information that might accelerate that timeline!
I am relatively new to this stock, have been buying in the mid-8s these last few months. With respect to European approval, I cannot find a PR stating that they have filed an MAA in Europe. Nor can I find any CHMP agendas that include discussion of the drug. I can only see that they have been given ATMP designation, a precursor step to the actual filing. As far as I can tell, they have not yet filed for European approval, so the approval itself is not forthcoming. Someone please set me straight, what am I missing?
Don't think you can contribute to a Roth for a child who doesn't have their own income
I don't disagree. I wouldn't mind an offering at a fair price (which is getting higher each day) or a partnership or some other deal. I just want to know what the plan is for this study which is supposed to be starting imminently. I hope the company will share this information with us soon.
I'm as bullish on this company as all of you, but the giddiness here is getting a little scary. I thought I had left the Yahoos behind by coming over here.
There is still a business to run and how much the PIII trial is going to cost and how is it going to be funded is a relevant consideration.
I have been burned many times before (and I bet you have too)
How'd you like the next PR to read "$75M secondary offering priced at $5.50"?
Crazier things have happened in Bio-Land. The big banks will screw small guys like us any day of the week to get in cheaply.
What are we projecting for the cost of this Phase 3 trial?
OK, yes, I understand what you are saying, but unfortunately we will not get the 24 wk data until the 52 wk data is complete...
"The readout of the primary endpoint of renal response at 24 weeks will occur after database lock at 52 weeks at which point the Company intends to submit an NDA."
http://ir.auriniapharma.com/press-releases/detail/57/aurinia-announces-plans-for-single-phase-iii-clinical-trial
Long wait either way... Good luck to us both!
Negative. It is a 52 week trial. Primary outcome measure at 24 weeks, Secondary outcome measures at 12, 24 and 52 weeks.
https://clinicaltrials.gov/ct2/show/NCT03021499?term=voclosporin&rank=4
damn ertade, that hyperlink was not my doing!
Bought more at 21.50. Traders and buyout speculators don't like to hear about long term plans, but I thought it was a great call. Cabometyx performing well, now let's move to first line.
When are they going to schedule the effing AdComm?!
So frustrating!
Thanks for listening
Established initial position today. Glad to be in at this price. Not scared about averaging down if it goes lower, good things ahead.
LOL...
"and"
kill-AND-fill
"kill" the stock with a negative analyst report and "fill" your buy orders at depressed prices, isn't this their game?
Anyway, whatever you call it, their shenanigans allowed me to get some shares on the cheap
oh, you mean the old, kill-and-fill?
Thank you! Even a blind squirrel...lol! I think the Takeda deal is good news for investors and that the downdraft was buyout speculators heading for the door. If/when cabo gets to first-line for RCC, then I think buyout will become more realistic. May require patience. In meantime, will buy on dips
Initiated small position here. Like the $50M vote of confidence from Takeda. Thanks for the drop! Ariad dollars
Initiated small position today. Ariad dollars
FDA decision is not looming. There is still an AdComm to go through and the date for that has not yet been set.
Exactly! AF, lol! ARIA taught me that this is a game, and you have to play it.
I was a lurker on the ARIA board, now looking at ARRY. Haven't bought yet. Waiting for the JP Morgan associated hype to settle down. I have read that an AdComm is planned for Bini, but I can't find any info about when it will occur. Keeping cash on hand in case of weakness, hoping to buy in the 8s
So, what do all of you think of Dr. Denner's other baby, MDCO?