Interesting to note, that at the end of the conference there was a question asked. What do you expect the top two side effects that would ultimately be on the box label for PDP? The best Uli could come up with was under very high dosing up to 300 mg there were side effects. I did not hear of any other indication that he mentioned other than very safe compared to placebo. If that is the only warning he can think of, the label should look pristine compared to other anti-psychotics. Off label anyone.
Expect meaningful pricing was stressed.
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They completed enrollment of the first phase III trial was on 5-6-09, ACAD announced the results on 9-1-09. This was the first trial and did not meet its endpoint. The ADP trial that will be starting this month seems very well controlled with familiarity, so I do not see why top line results for this trial cannot be posted in the same time frame - four months from the completion of enrollment.
The second trial that was a success completed enrollment on 9-5-12 and announced top line results on 11-27-12. When the company completes enrollment for this ADP phase 2 trial they should announce the expected top-line results. We are probably looking at April-May time frame, but depends on when the enrollment is completed.
The timing of this trial makes all the sense. Recruitment through November - December (holidays) period and actually start the trial in January.
200 shares dropped it to 20.00, desperate shorts. All is good with ACAD. The starting of ADP, this month huge positive.
Official Title: A Multicenter Phase 1/2b Study of the Bruton's Tyrosine Kinase Inhibitor, Ibrutinib (PCI-32765), in Combination With Carfilzomib (Kyprolis™) in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma
If this is the trial you are referring to it is not yet recruiting, but is posted.
Based on Roche's obinutuzumab's recent approval, the timeline for ibrutinib potential approval should be sometime in December based on the time Roche filed their NDA to approval, and the amount of time PCYC trailed with their breakthrough filing, approximately 1.5 months. Just a timeline comparison.
I would buy 1/2 of what you intend to buy this a.m., the other half maybe wait a day a two. Either way your average will probably be less than 24.00 which is good.
Today's third wave of selling as been handled well (so far) compared to the two day sell off earlier in the week. Volume is contracting, again comparatively. So I would say the panic (margin call) selling pressure is starting to exhaust itself out. In the long run we will have a more solid ACAD with shares left in long term holders hands who can see the true value of the company moving forward and sit through the volatile trading days. We may have three higher lows on the daily chart if the stock holds the low this morning of $20.75. Each short effort will have less of an impact on the stock IMO, hold long and strong as they say.
We know that analyst are a conservative group as a whole, and only consider the information that is right in front of them or will be present in the near future.
I have done my own analysis on just the US market for PDP, and come to a conservative price target of $29.00 based on peak sales, no off label, or ADP, or Schizo, just US PDP. Best.
A) The fundamentals have not changed, and in fact have improved over the last months from what I have read.
B) Overall sector and macro government sending higher risk stocks that have had big runs higher down significantly. Add in margin calls and that's what we get today.
C) There is no information that large holders are liquidating shares, and the two largest holders (30%) of the stock is know for holding for years as long term holders not traders.
D) The average analyst has a $26.00 near term price target on the stock, and we know they tend to be conservative.
E) Due to patent expiration and the clean safety profile that PIMA has, big pharma should be quite interested in acquiring this company.
In the short term we could get more weakness from people who have to sell not want to sell, this non margin stock.
We hold ACAD shares and options.
Regarding a buyout scenario.....Hard to imagine the buying company accepting 100% to 120% to around 45.00 from this point. A 45.00 offer is a 4 billion market cap, and I think that is about as fair as you can get. I don't see this as a point for buyout unless a 120% premium is offered.
Even though we are long term holders, I like to track the daily chart patterns. The 15 minute candlesticks are only trading on average, at 81K per 15 minute candlestick today....showing no conviction and below the moving average of around 94K per 15 min. Not much conviction on this pullback.
Other BB top stocks are down today PCYC and SGEN along with ACAD and Biotech is down around -2% today overall. Today has the look of like many are just waiting out the politics. But we may have to get used to this in the short term.
This is a healthy pullback for the market and for ACAD especially to work off the overbought technical readings on the daily and weekly charts. Could pull down to the $26.00 level, but that will not be the end of the world, and I have no ambition to be gaming this stock in the short term either.
We also hit a number of analyst near term targets, so their target areas are good consolidation points between $26-29.00 until we get further updates from ACAD.