Following up on my own message under 'Needham webcast' I would just point out that lesser programs in the Parkinson's space have been granted fast track status. See below (and this is just one example). Personally, I think they're going to apply for fast track.
Fipamezole is an antagonist of the adrenergic alpha-2 receptor with a novel mode of action in the treatment of Dyskinesia in Parkinson's Disease. The rationale behind the development of fipamezole is to increase noradrenergic release in certain areas of the brain, resulting in rebalancing of the distorted brain network and potentially alleviating symptoms of advanced Parkinson's disease such as dyskinesia, motor fluctuations, orthostatic hypotension and cognitive impairment without exacerbating the underlying Parkinsonian features of the disease.
In 2006, Santhera and Juvanita Pharma entered into a strategic cooperation to advance the development of fipamezole for the treatment of Dyskinesia in Parkinson's Disease. In summer 2009, Santhera reported posivie data from a confirmatory Phase IIb study, which demonstrated that fipamezole reduces Dyskinesia in Parkinson's Disease. The study results also suggest that the drug has the potential to reduce "off time" and improve cognitive function. Furthermore, the reduction in dyskinesia was found to be strongly correlated with the investigator's clinical global impression of improvement in overall condition.
In August 2009, Santhera executed its call option to acquire all rights to fipamezole. Today, Santhera holds worldwide rights to develop and commercialize this first-in-class compound.
Santhera has EU patent protection for the intended oromucosal formulation until 2023. The program was granted fast track designation status by the US Food and Drug Administration.
Is that addressed to me? If so, I'll correct you on that one. I'm way long and regardless of fast track, this is going to go up. I think you must have been addressing that to someone else....if not, I'll clarify that I'm long. I think that's really obvious anyway.
Six months is the FDA's stated goal from request to time of filing.
Acadia has of course states (even in the presentation today on slide #18) that the 'current target for NDA submission (is) near the end of 2014'.
However, I would just throw out there that Uli states clearly (at least twice) that a large part of the reason that the FDA waved the second Phase 3 was due to the 'large unmet medical need'. I would just point out that a key criteria for fast track status is that the program fulfill a large unmet medical need.
It's impossible to know if they will try for fast track (or if they have already filed), but it's very clear that Acadia describes this program as fulfilling an 'unmet medical need' when discussing the FDA's decision. If this is the case then fast track could happen in my opinion. It's not a long process so I imagine that it would happen within the next month or two if it's going to happen.
Thanks for the kind works regarding my posts! I enjoy reading the postings of others as well. I hope we can get a really good discussion going here as Acadia is worthy of that. We can have a good time posting her for the next few years while this company slowly builds into the pharma company that we think it can become. These are exciting days for sure.
I agree with you on "fast track" application. I think when FDA was satisfied with the data on Ph. III trial, due to safety and efficacy, they opened the door for fast tracking pimavanserin.
Sentiment: Strong Buy