I read a post on this board suggesting the 021 trial could take 18 months. I am new to bio stocks so I don't completely follow the math. Lets start with the givens:
Two week pre trial screening
Six weeks trial period
Three weeks to compile trial data (being conservative, I think)
Four weeks planning (not the 020 plan, but logistics with CRO, locations, etc...)
That comes to 15 weeks.
12 weeks to recruit patients
Total is 27 weeks....approx 6 months.
What part of the trial am I missing or is the period I indicated off?
The time comsuming factor in the 020 study was finding the correct canidates.Something to consider about the 021 trial is that Pimavansern is no longer an experimental drug, and so there should be an abundance of applicants to choose from for the trial. I would think that a doctor,and caregiver would do their best to get a patient into this trial because the patient will be recieving a medicine that is proven to work. If they don't recieve Pimavansern during the trial they can recieve it by rolling over into the 015 study.The 021 study is a win, win for the doctors,caretakers, and patients as well. The only fly in the milk would be that if the patient knows the history of Pimavansern they may have a positive responce to a placebo
The infrastructure to conduct the -021 trial is already in place. They will use mainly the clinical sites which were used for the -020 trial. That simplifies to establish contracts for the study with these sites and train people conducting the trial. So basically they are up to speed as soon as the trial starts.
I hope they will extend the participation of subjects in the trial from 12 to 16 or even 20 weeks. According to the data shown on Nov 27th, IMO that would further significantly reduce the risk of failure and at the same time better document efficacy and those exploratory endpoints like care giver burden, which would be a great marketing tool once the drug is launched.
To your question, I believe the -021 trial can be accomplished within 12 to 18 months.
While they initiate and execute the -021 trial, they should partner pimavanserin for schizophrenia and AD psychosis with a large pharmaceutical company eg Lilly. In addition to a significant upfront payment I would hope the prospective partner would also do an equity investment of about 150 to 200 MM at a 50% premium to the current pps. Eventually, I see ACAD having about $350 to $400 million cash on hand.
The area that takes so long is recruiting the ideal patients. You must be positive that these are patients that actually have PD psychosis and not something else. They cherry picked for the 020 trial and it worked beautifully. My guess is that we'll see more of the same. However, they learned a lot during the last trial so it should go faster. I'm pretty sure they'll use the same trial sites and do a similar trial design. Personally, I would start and control the next trial completely if I'm Acadia. If they can duplicate the 020 results then it's obviously a potential blockbuster and then some.
They raised a good amount of cash so they're in a great negotiating position for a partnership. However, the risk of a partner is that they try to dictate the trial design and screw it up. I think Acadia will get the trial up and running and then will start taking partners later in 2013. Of course, if a great deal comes to them them who knows what might happen.
last patient in 020 was enrolled in September of 2012, around 24 month after trial started, so who gave you an idea that all 200 patients will be recruited within 3 month ?.
Sentiment: Strong Buy
Just giving this a bump with hopes some experienced bio investors could add some insight. I amguessing we will here more details in a PR just before the CC, with further follow up Q&A during earnings CC. Announcement of an aggressive timeline could propel the stock 10 percent.
I see them partnering very soon and that $$$$ value will be huge. They have a lot on their plates right now and all of the stock is tied up. They can price this anywhere they want as the majority of the weak are out. They had this announcement too:
They are definitely not a one trick pony as so many on this baord tend to believe. We are going much higher in the next few months.