Much too shady to not have been some under the table payoff or favor-
suboxone generics will do even more business now..
I recall that last advisory meeting on the public forum portion some compelling stories by patients.
I expect the same or even more compelling stories to tip the scales in Northera's favor for approval.
Looking forward to the good possibility of 4.00-7.00
The unmet need and the competitor's safety/efficacy flaws PLUS apparently FDA in line with Chelsea for post approval duration trials, gives a MUCH greater chance for approval..
However,as we have all learned in past,nothing is ever a slam dunk but on the surface,things look good here..
Tough call-The BIG Cheese' wants out and Braeburn/Titan want to be in this space
Suboxone is not going off the market,it will just be sold and will still be somewhat of a competitor-Probuphine should get a label change and should be promoted not necesarrily as a stand alone drug,but as an adjunct to suboxone therapy..
Would be interesting to see clinical studies of probuphine + suboxone versus suboxone alone-market possibly Huge...
No material events before meeting so why would it go to 2.75? Hopefully it wont hit .75
I am peeved off what happened-Didnt lose here but surely didnt profit as expected.
Bad week-I owed some AMRN also.
25 million for FDA approval and 20% net sales royalties any big pharma could have given that to pSivida
so why didnt they? I am just being a monday morning quarterback trying to sort things out.
Was this not an interesting lucrative approval type product for a big pharma to pursue?
Another trial and 12 month followup so we are talking maybe 3+years for possible approval.
Alimera has to decide if they will pursue US or give up here and focus ROW.
That advisory meeting in January will help sort things out--
Maybe better off having ALIM raise cash and give pSivida 75million to retain full US and EU rights to Iluvien and wash their hands of working with Alimera anymore...
Iluvien in the hands of Pfizer o Roche would have most likely been approved.
Also, no excuse for AGAIN CRL indicating manufacturing deficiencies.
That should have been cleaned up a year ago//
Alimera screwed this-
I dont now the far history of Iluvien development
pSivida has some Big Pharma partners but not for this product, Why?
How come Pfizer or another big company didnt take on this particular product?
Was it doomed to fail for approval in US? Just pondering..
Something has to give here-FDA's hard,unfair stance based on assumptions and not the positive data in front of their eyes has put things in a conundrum..
Will Dr.Young help soften the FDA up and help them wipe away the fog from their glasses??
No matter what,NDA i Am pretty sure has to be refiled at some point trials or not, because they still need a Human Factors study,and dont forget the REMS has not been fully agreed to and was put on hold after the CRL.
Thats the problem-FDA is actually assuming drug is ineffective for reasons that have nothing do with actual trial results.They are coming to fairy-tale unfair conclusions
FDA is surprised by the positive data and believe addict participants were cheating, thus they dont believe the plasma levels can equate into what the stat significant data is reporting..
Not a bash on Titan for those who gave my comments a thumbs down-j it's ust the outrageous requests by FDA I dont believe Titan has any current data to validate what FDA wants-
get it? got it? good!
I think it's not a mater of making money off other peoples suffering- it's more like drug is available for free and company trying to profit from a drug that is currently free to all LEMS patients right now.
Nothing wrong with trying to make profit I say but there is a free option for those who choose.
Ahmed,Jacobus never pursued their drug for FDA approval all these years until now.
THey gave it away for free and never wanted any profit making
To protect what they started,they now seek regulated FDA approval due to Catalyst and Biomarin pursuing US rights.The race for FDA approval is now on..