Yes, sorry I meant to comment on that. I agree with you completely. I know this is a proof of concept trial to some extent, but positive data might provide the necessary basis for a Phase 4 post-marketing study to expand the label. This is definitely the strategy I would employ if I were Acadia. One of the really intriguing updates will be a more official timeline for this study. I don't believe that they're necessarily in a rush as a Phase 4 strategy is optimal. It's such an intriguing opportunity at this stage IMO.
I read that article as well. My point was not to insult Napodano in any way as I actually like his research. My only point is that he is definitely young and he cannot know the significance of Acadia's success from a historical perspective.
Acadia's success comes from lessons taught by companies such as Interneuron, CoCensys, Titan, Neurogen, Neurocrine, Cortex, Memory Pharma and of course many larger pharma companies. These were stories taught in the late 1990's and in each case these groups were not able to generate the data necessary for success. Much of this may have come down to clinical trial design...in some cases it was bad luck and in other cases maybe it was just bad strategy. What I like about the Acadia team is that Uli and Tom have been there from the start and they learned these lessons because these lessons were being taught in the early days of Acadia. I'm very happy that JN got you into Acadia and for that he deserves great credit and you deserve great credit for taking the chance. What I'm trying to say is that Jason of course was explaining what Acadia was explaining to investors at that time. My biggest point is that the team is Acadia is just incredible seasoned. I don't question any of their moves or instincts. They hit a homerun where no one else has and that is why they are the first company to EVER have a second pivotal Phase 3 waved off. By the way, I was an investor in every company mentioned above.
I'll remember your post. Make sure to own it when the time comes and it's your being slapped around;)
Picking patients is a very selective process. You must make sure that your patient is indeed suffering from ADP and not some related/unrelated dementia. Also, you want to make sure this patient is a good candidate and healthy enough to be in the study. I say this of course keeping in mind that many of these patients are not that healthy. Finally, you want to make sure that ADP is key to their pathology and not secondary to another condition or even primary to another condition. They will screen these patients like hawks to get the right patient database. I think this is one reason the FDA was so confident in the PDP data. The care that went into that trial was unusual. It's too bad Acadia cannot patent their CNS clinical trial know-how because most CNS companies never see this type of success. That's one thing guys like Napadano can't realize because they haven't been around long enough to truly know the history of this sector. I know it from the start and it's riddled with high placebo responses and poor clinical trial designs. Acadia should take all the time they need to get this right. I have no problem waiting. The upside is too large to be reckless on any level.
I wouldn't read too much into it. He was following Acadia way back and has always been supportive. However, analysts always revise targets. As you said, he left out Europe, lots of indications and was very conservative in his estimates.
You often don't know just how huge a drug can be until it's launched...it's amazing how an indication grows. Sky is the limit for pimavanserin and everyone knows it. It's just a question of time or will a buyout happen.
Interesting take. Why don't you give us an analysis of that 'lousy discarded' drug? While you're at it, give some thoughts as to why Cytopia sold their lousy JAK to YM for pennies and a couple of years later YM turned it into a $500M M&A deal. I don't deny that the previous owners were suckers for selling but this asset has value in my opinion. We'll see....all my opinion and do your own dd.
You said that 'he's doing what a lot of analysts do' and you're right. He's being very conservative so he can continue to up his forecasts over time. Napodano puts some interesting information out, but his analysis is not the one that is going to move a company like Acadia.
Anyway, his analysis seems to miss much of the story. He basically gives a very conservative view of ADP and PDP. He doesn't really talk about the revenue generating capability of past antipsychotics. Also, use of the term antipsychotic usually brings up the potential of a broad offering such as schiz, bipolar, major depression, etc. As others said, he didn't discuss any of this.
Bottom line....anyone who buys/sells Acadia based on this report probably should be here in the first place! No offense to Napodano as I enjoy some of his pieces, but I'm looking to the bigger banks to give their thoughts here. Even then I'm fully aware of the strategy of giving low estimates so you can bump this up over time and continue fruitful banking relationships with the company.
I'm still angry that I missed $20 last week. I want that chance again, but don't see it happening. If we get close I will add once again.
All my opinion...do own DD.
I don't think Acadia has written anything in stone regarding ADP trial timelines. The 2 year reference comes from something that Tom Aasen said on the earnings call.
We have learned beyond any shadow of a doubt that very careful patient enrollment is critical to the success of Pimavanserin. Too many dementia related conditions present with similar symptoms so you have to be extremely careful to make sure you're getting the correct patient group.
I think they will be extremely careful with enrollment. They screened the patient population for PDP very carefully and I'm expecting something quite similar in ADP. I personally. do not expect to see data in 2014.
It definitely made me say "hmmm". I think it may be a long shot that the FDA allows Acadia to file sooner, but if the data is really clean then it may be possible. You just have to be totally impressed with this team.
Thanks for your note by the way. I like that some of the familiar names are still here and held through the storm. It never looked bad, but it's starting to feel very positive again. I was out of the country last week so couldn't pick up any at $20 so I'm not happy about that, but otherwise very happy with the conference call and everything I heard.
I felt compelled to revisit the Phase 2 ADP study strategy since we now know that the ADP trial will be carried out with great care over a period perhaps lasting as long as two years. Personally, I am relieved. The absolute last thing I wanted to see was a rush for quick data with the risk of poor clinical trial execution. I hope the same effort that went into the PDP data goes into generating the ADP data.
However, I also think that there is more here than meets the eye. We know that the NDA is scheduled for the end of 2014 (though there are rumors on this board that it may happen sooner). This would mean that Pimavanserin very well may be approved before there is any ADP data available. As such, I am going to continue to stress my opinion that any large ADP study will have a Phase 4 post-marketing structure geared at label expansion. As I stressed before, I am much more in favor of expanding the label to new indications than trying to show the value in multiple indications before approval for PDP.
I love how Acadia is executing. It's strategic and methodical.
All my opinion. Please do your own due-diligence.
My opinion is that some type of deal is likely before year end. I realize there is little confidence in management, but I went through a similar issue with YM Bio. Management lost the confidence of investors and had a lot of pipeline trouble. However, the JAK space is hot because of JAKAFI and because of other deals in the space. Also, there has been a lot of positive data generated with these candidates. I personally am looking for a deal before year end. Again, all my opinion and do your own DD. You know the routine, but bottom line is that this is just my opinion.
Why am I the only one on this board who can have an even semi-intelligent discussion about JAK inhibitors? The longs here complain about the company but can't discuss the pipeline. The shorts here can't discuss JAKs and figure out why they're shorting. It's obvious that the JAK is the best asset in the company at this stage and a licensing deal and/or M&A around this asset is the play. Study Incyte, Galapagos, YM Bio and other players in this space and then tell me why this one has no value. This is not just a me-too in a crowded space. What is me-too about it other than targeting myelo as the entry indication which is actually very intelligent? SBio just couldn't advance it...it was given back but it's equally true that Cytopia couldn't advance theirs which is how it ended up in the hands of YM for pennies and then sold to Gilead for $500M. It took Incyte making it to bring some fire to the space. The FLT3 component is a differentiating factor in my opinion and especially for certain cancers. That's what has me interested.
Also, the limited data in RA was interesting.
Long story short, the head of corporate development is an M&A guy. They have an asset in pacritinib. I don't care if the license it, sell the whole company or sell the asset...I just say there is an asset here with value right now and that I'm personally expecting a deal around it. All my opinion and do your own dd.
Zalicus was never a scam but it was never in the league of Acadia either. They didn't have anything but a troubled drug that had bioavailability issues in the old formulation. However, there was very little data on the new formulation or that the "on" state and "off" state elements made any sense at all. It bombed. That was nothing but a stab in the dark quite frankly. Anyone who got spanked there was gambling anyway. Acadia has generated enough data on Pimavanserin to actually be able to justify the method of action and to know the safety. This isn't an ordinary company anymore. Things have changed. I was here when Acadia was the baby company with ambiguous data...this isn't the same Acadia. They were able to grow up and are now just starting to mature. Maturation in this sector takes many years so we know that translates into many years of growth or M&A on excellent terms.
Maybe it will make sense to you when you understand the JAK landscape. Do some DD and let me know your conclusions. Show me the groups that hold JAKs, those that sold JAKs and those that partnered JAKs. JAKs are hot. Bottom line. Everyone said YM was bust until it sold for $500M for a JAK with perhaps even less data.
You guys are either joking or really don't know how this works. He obviously has many many many options that remain unexercised. I don't believe that any investor doesn't know this so I'm probably wasting my time with this post.
Here is what I say.....bag Pixuvri. The money is in the JAK. YM got $500M for a Phase 2 JAK 1/2 from Gilead. I admit that CTIC is a POS but the asset has value. I think they should sell this company and let the investors out. I paid nothing for it...I admit it. However, I know that JAKs have value now. I don't want to see a licensing deal...I want M&A. Hoping this crashes down some more...wouldn't mind a second load. I think that deal they're touting is coming. JAKs are hot and these guys are holding a solid candidate. Adam F. is right that it may not matter for myelofibrosis but that's an entry ramp...it looks interesting for oncology indications. It has value IMO. I made a boatload on YM btw....doesn't mean I'll make it here by any means but the JAK should have value. All my opinion. Do own DD. This is one miserable board btw. This company must have really made people here very very upset. I'm just here for an exit.
Is that what he said? I'm no Feurstein (he's actually really funny) but I think the whole point of the JAK program is to bring money to advance the pipeline. I'm now wondering if this could be a clean M&A deal. The company can't really advance things so it's possible this could be sold off. Keep in mind that YM was sold for $500M for their earlier stage JAK. The background of CTIC's head of corporate development is not licensing from what I can see. He's an investment banker. I'm thinking M&A. Could be a nice pick up for the right group. $5.00 gets it done easy. Honestly speaking, $4.00 would get it done IMO.
News almost never comes out for Friday. Shorts who like to close positions before the weekend are going to feel this one today. Could be a squeeze. i don't day trade (or short) but the increased activity on the board suggests shorts are out for a roasting today.
I typically have online access to all journals but cannot access The Lancet! Too bad. They do have a short audio clip for anyone interested. It's free and discusses pima for about 4.5 minutes. I'm sure I'll be able to access it in the coming days.