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Here's the 120 day chart. Basically you can drive a stake in the ground that the review will be done by 120 days...Almost 100%....let's see.......and hope their advisors had the targeted subset right as there are doubts their population(,200,000 prevalence) is too large to qualify...
http://www.accessdata.fda.gov/FDATrack/track?program=osmp&id=OSMP-OOPD-Percentage-orphan-drug-designation-reviewed-completed-in-120-days-or-less
Why is the orphan issue taking so long if FDA themselves says answer usually less than 90 days.
Was the request deficient based on prevalence? Just very odd....there are published stats now showing 83% of requests are done within the 90 day window for 2012. What gives with DARA then? Apporx. 70% of requests are approved....They definitely downplayed this in the 10K....
I wonder if the answer is NO....
http://www.fda.gov/downloads/ForIndustry/DevelopingProductsforRareDiseasesConditions/OOPDNewsArchive/UCM294786.pdf
JAson Napadano follows DARA and has already sent a few brief tweets on the good and the not so good. He mentions a full report in the next few weeks.
DARA needs to partner bad here and I think they realize that. They don't have the funds nor human resources to get the traction their excellent products should. Turn that task over to big pharma along with the next trial funding....
I think within a few days of Orphan news we hear of a deal........
I don't think the 10k even mentions orphan application
Crl on business wire
Any of the bio experts here care to explain the orphan drug rules. I thought that the target population could not be >200,000 lives. In the case of DARA, I understand the unmet need but the pain issue suffered by cancer patients is not a rare disease. Isn't this more of a fast track situation versus orphan. Have the rules changed or is my understanding incorrect?
Will this company ever have news.....the wait is endless here......tired of the old undervalued and appreciate line. I hope this is not one of those where mgt. could give too hoots about communicating to shareholders........
Based on the below a buck drag I bet orphan ststus comes by mid next week...........
going up on huge buying now...
Don't see much downside of holding through. The 5% chance of a class 1 CRL which will be rapidly corrected would limit downside if one believes its possible to even get another CRL. The drug is proven safe & effective indisputably with the QT study. I do believe this gets approved and word will be out tomorrow. If not, shame on both the FDA and company if they couldn't work through the process successfully to bring relief to so many cancer pts. when its not a matter of safety or efficacy, and can only be a minor manufacturing or delivery hangup. I will be extremely surprised with another CRL....not in this case.....no way at this junction....
Lots of buying partly offset by the weaklings
ZIOP ...bad news...
While anything is possible, I'd be stunned if FDA issues a CRL on the 27th, delaying to the last minute notification of any remaining concerns, thus, extending even more time until this beneficial drug gets to help chemo pts. If there was an issue remaining, they would have already issued a CRL IMO to get APPA in motion quickly... That is why approval is a given here.
Very sneaky shady trader tricks this am with folks posting orphan approval w/o the qualifier that it was europe........
This is an insanely low market cap for a company with their oncology products and a potential blockbuster orphan soon.
New SA article just hit.....
That was the poll result in Adam's survey of public opinion....
Did biobreakthroughs reports on IGC come out yet....must of been his tweets...
Just amazed at how the interest here hasn't escalated. Blockbuster approval news can come at any moment and not a single premarket post. I don't get what folks are missing. Folks pile into worthless bio crap all the time.....but deliver a winner on a silver platter like APPA and there is relatively no chatter but a few....
Considering the market for this drug, I am amazed at how little activity we are seeing here on the board considering the hoopla often surrounding FDA approval dates for drugs of very limited use. Maybe thats a good thing.....just hard not to recall the times that stocks ran into PDUFA big time even if their drug had no viable commercialization route. I rhought APPA was the best we've seen in a long time........
Ready for the action........
It is hard to pathom that they've spent three entire years righting the ship and dotting all the I's and T's only to get slapped back again. I just cannot contemplate that happenning nor the FDA waiting to this point to issue another CRL. Approval is happening here........
Added large again this am............
Added large on Friday....................
APPA --- there are no credible critics even out there for apf530. This drug is safe and effective and will immediately take hold in the chemo marketplace. We have a clear winner here as folks have convinced me that approval is highly probable if not guaranteed....thanks for the thorough analysis on 2nd PDUFAs. The funds may run this to higher levels than you think. I knew from my review of the trading last night that it was time to go long and firm up my real stance on this one..... I loved it at the end of 2012 and love it now at these levels.....we have a huge winner IMO. I see this steamrolling upon approval and running up nicely as well......
Congrats APPA longs....we've weathered the storm and brighter days are ahead. APF 530 is a homerun drug and the premium assigned by the market in approval may well exceed everyone's expectations......green days are dead ahead........
Not pumping. Call it a fresh start with a more realistic and optimistic view. Now lets get apps moving
Don't believe the 2nd pdufa can lead to anything but approval
Approval is a given imo
Tomorrow we begin the reversal up
APF530 is a homerun.....don't be lulled into thinking otherwise by recent trading
I don't think the board is interested in getting into the weeds. I believe the details of my concerns are best left to a physician panel......
you may be right on approval but my concerns are well founded IMO.
If today was any indication, we will rock soon enough..
My concerns are focused on the dosing system, chemistry, manufacturing controls and a bunch of clinical aspects.
I remain deeply cautious on FDA approval of this drug for CINV. I also remain gravely concerned that even at these levels the market is irresponsibly assigning a future value to the shares that doesn't reasonably reflect the commercialization challenges. I believe regardless of my view that this will be much higher prior to the 27th as the games are soon to begin....the fund only has < 10% left to go.
Not surprising....the healthy cash position came at the expense of enormous dilution........
This is PATH all over again,......unfortunately that one did nothing to speak of on approval..........
awful set up here for longs....even if approved...going to be competing with outrageous number of instititutional sales on the sell side........
This has been a bust of a trade ...........
This is heating up.........