Let's get the disclosures out of the way first: 1) I'm long. 2) I loaded up more at $4 today. 3) I don't believe AVXL should have released any data at 5 weeks, but should have waited until 12 weeks. 4) Nonetheless, I am convinced that the "one back" memory data (and secondary measures) are real - to have that kind of statistical movement after 5 weeks with 75% of patients who were on donepezil already for 3 months seems remarkable. 5) I believe that the 12 week data will continue to be positive given the early trend and that when (and if) it is, this stock will be a bottle rocket. 6) I would not be surprised that the FDA grants breakthrough status if data at 12 weeks continues to show this trend, and if AVXL applies for it. Lots of potential positive catalysts.
My one beef todaty is that it is unclear if the FDA gave guidance AFTER the early data was given to them, or if AVXL is merely reiterating the guidance that the FDA gave upon the commencement of the adaptive design trial. If its the latter, the Press release is very cleverly worded. In the meantime, I'll take the gains. I do hope the company will clarify whether they had a meeting with the FDA with the 2a data in hand or not.
and some interesting data so far. Lots of noise on both the longs and shorts side. The range of response goes from "complete failure, not statistically significant" to "PPS will zoom to $200." I can't quite grasp how AVXL managed to get so hyped up (or down) with such early results, but let's all agree that at this point the fact that the data are not statistically significant is not at all relevant (this is not a statistically powered study). Let's also agree that AVXL's drug appears to have no significant safety issues, and that at 5 weeks we can only observe observational trends that may start to have more meaning over time (24 weeks perhaps). Given all that, the cognition data by no means dismisses this drug but instead begs for more. Let's look at four data sets for groups tested (baseline, 5 week 2-73, and healthy control). (the middle number in each set is Anavex's score). P300 = 5.99 +-.58; 7.09 +-.72; 7.36 +-.39. Task Accuracy 83.8 +-3.9; 92.6 +-2.4; 94. +-1.1. False alarms 3.4 +-1.0; 1.0+-.05; 1.1+-.2. Reaction time 559.0 +-24; 492.6 +-23.8; 258.6 +-11.4, If you take the t0p of the variance or baseline (e.g. for P300 baseline score of 5.99 +-.58, you take 5.99+.58=6.57) and the bottom of the variance of 2.73 (e.g. for P300, 7.09-.72=6.37), there is no absolute difference between the two for P300 but there is (in Anavex's favor) for the other three measures.Again, ALL OBSERVATIONAL, but nonetheless interesting. It's just a matter of time, (and a longer, bigger study) to see if the observational positive differences in one or more of these and other measures hold up or become larger.
In researching the investigative unit of the SEC, the first line of investigation is usually an informal one. Only when the SEC has enough evidence that makes it likely that illegal trading has occurred is a subpoena issued to open a formal investigation. So that means they have their eyes on one or more folks outside the company who have been manipulating the stock (probably short), causing the price drop in November that took the price from $14 to nearly $3. To which I say, round 'em up, lock 'em up, and throw away the key!
There has been quite a bit of consternation about MS's negative outlook on Relypsa. It is MS's interest to do whatever AstraZeneca needs, as they make a fortune off that company. Morgan Stanley was the financial advisor for AstraZeneca when Pfizer tried to acquire them. I believe they were also advising Astra on the ZS Pharma deal. Astra's law firm in the buyout of ZS was Davis Polk & Wardwell LLP, which is joined at the hip with MS. That law firm in fact did the legal work to form Morgan Stanley in the first place, and has done large deals for MS too numerous to count. ZS-9 is not approved. MS must do everything they can to protect the value of ZS for AstraZeneca while they shepherd this through the FDA. It is in their interest to play down the possibilities for Relypsa - and MS has hammered on that company for months now. Bottom line: take what Berens and MS say about Relypsa with a truck size block of salt. In the meantime, don't forget that Actelion offered 2.5 billion for ZS and lost the bid, and Sanofi has its entire nephrology salesforce behind it. Rest assured that there are a minimum of four companies(Actelion, Merck, GKS, Sanofi) and probably more like six or seven evaluating Relypsa. This could go any day.
BPX-501 will greatly expand the number of transplant procedures that can be done due to increased safety, faster recovery, less infection, far less if any graft versus host disease, and much quicker immune system restoration. All of these improvements will have an economic benefit - patients will have fewer ICU days, in-hospital days, and fewer relapses, translating into billions of dollars of savings globally. Until a company like Bluebird makes transplants obsolete, which won't happen for another 10-20 years if at all, BPX-501 could easily become Standard of Care adjunct therapy. Perhaps it will add $20,000 per transplant to the $80,000-$300,000 current price tag, depending on the closeness of the match and complexity of the procedure. There are currently around 45,000 procedures a year. If Bellicum's T cell cocktail expands the number of possible procedures AND is used as added safety in existing levels, this could be a billion dollar cell therapy in 5-7 years. Not to mention the four other therapies being developed by BLCM. Once this possibility becomes a reality for future growth, BLCM could sport the same market cap of KITE, which is 3.5 billion. That would put BLCM at $132 a share. I actually wouldn't be surprised if AMGN makes a play for KITE next year, perhaps picking up a BLCM in the process. But for my money, cell therapy 2.0 is now BLCM and CLLS (JUNO and KITE are 1.0). If CLLS' off the shelf therapies work more broadly, watch out below for JUNO and KITE!
That's correct. According to Dr. Mcfarlane, 75% of the patients had been on Donepezil for at least 12 weeks. Nearly 100% of the stabilizing effect of Donepezil occurs at 6 weeks of treatment, and starts to decline after that.
(Any AD docs out there to fact check me?) Given that, it would have been harder for 2-73 to show any effect, not easier.
Irbecke2 and redbarron12 both know what they are talking about. This is from the Office of the Chief Economist, USPTO, in a review of over 2 million patent applications: "The first significant correspondence that an applicant receives from the [patent] office is called a “first action on the merits” (or simply “first action”).
The first action includes a search report with a listing of relevant prior art that supports
the examiner’s decision of either allowance or non-final rejection. The office allowed
11.4% of the progenitor applications at first action and delivered a non-final rejection
decision for 86.4% of the applications, with the remaining 2.3% being abandoned prior to
first action. 36.1% of the progenitor applications were allowed after one or more rounds
of amendments and negotiations with the examiner, but prior to a final rejection. 14.5%
abandoned between non-final rejection and final rejection. 38.7% received a final
Well now we have the numbers from ASH: 21 fewer hospital days, significantly fewer relapse hospital days (let's call that 4 fewer); that's a reduction of 25 hospital days over 1 year @$2000 a day = $50,000 savings. Add to that zero percent deaths versus 10%, and significantly less complications which when they occur can add $25-100k to the total procedure costs, and you can safely say that, all in, BPX-501 has a $75,000+ hard cost economic benefit on average per procedure, and a substantially higher benefit once you factor in the zero chance of dying. The key question is going to be to what extent this adjunct therapy enables docs to expand the number of t-cell depleted haploidentical stem cell transplants. One could argue, given these early results, that the answer is: significantly.
It will have been a month and a week on this Monday morning since rumors started flying about a Merck bid, followed by rumors of other bids and multiple companies interested. I think the time is up - 7 am Monday sounds about right for a buyout announcement at $52-$55 a share. If it happens, cheers!
Actually it says this: "...announces that it is moving forward with the development program for ANAVEX 2-73. Guidance received from the FDA confirms the Company’s strategy to advance ANAVEX 2-73 for the treatment of Alzheimer’s disease in a larger double-blinded, randomized, placebo-controlled Phase 2/3 trial."
Guidance...confirms company's strategy...which was set at the beginning. All I'm saying is that AVXL (you reading this, AVXL marcom?) would get an even larger bump if they can say "We received FDA guidance about continuing with a larger, double-blinded study after discussing initial phase 2a data with the FDA." So say that if you JUST received the guidance!
In the meantime, the shorts aren't covering yet because, just as the longs waited too long to dump their shares, the shorts are now going to wait too long to cover. They will throw in the towel if they see the price holds up to and through close (I think we'll close over $6.50, but we'll see of course), and/or if it continues upward momentum tomorrow and the rest of this week. I suggest everyone do what I did and increase their positions by 60% right now! All together longs! :-)
It's not going to drop to the $4's. A couple of folks have already explained what their IR firm said, and what Anavex said regarding this matter: No corporate officer has bought or sold any shares in AVXL (which I didn't know until reading the post) except for some small amount purchased months ago by Missling and was disclosed at the time. In the meantime, I wouldn't be surprised to see Shrkeli's name surface on this investigation, since he was publicly calling AVXL a worthless company. I have no doubt he was shorting it while doing so.
Jet,As someone whose mother died of metastatic pancreatic cancer within 3 months of diagnosis, and whose wife's mother also died from the same illness within 9 months of diagnosis, I think this preliminary data looks fantastic. Most people unfamiliar with the ravages of pancreatic cancer don't realize that to date, after decades of drug trials, nothing has moved the needle on pancreatic cancer. Once diagnosed, a patient is told they have between 3-11 months to live, unless surgery is possible, and even then the outcome is bleak. While the percentages are not reliable at this point, (42% versus 23%), that still represents an 82% improvement with anecdotal data. While not being able to quantify anything, clearly something very positive is happening here. and the fact that they got a complete response - even one - is phenomenal in this disease. If any oncologists are on this board, please weigh in.
OMG of course not! $10.47 are you kidding me??? There's NO WAY we'll ever see that again. NOT WHEN 72,000,000 SHARES TRADED HANDS TO TAKE IT FROM $7.20 TO $10.47!!! Clearly dude-bio-X, there's just no demand for this stock!!!!
add this to the above address
Steven that's not entirely true about a buyout. If the triple combo works (i.e. in 4-8 weeks), JNJ immediately ramps to about 5-10 billion in sales per year, depending on the speed of cure. (One can argue that if their cure rate is at 6 weeks or less, Harvoni is DOA (dead on arrival) just as Harvoni killed JNJ's billion dollar NS3/4A PI Olysio)That's a $1-2 billion royalty for ACHN. That alone will make ACHN worth $3-6 billion in a buyout (and don't think for a second that a third party will buy this out right under the nose of JNJ, given the opportunity). And if at that time the Complement D program has any legs at all, add that in to the purchase price. (In a very big way I might add - just look at the market cap of ALXN.) So Mag can talk about bidding wars all he wants - they could be very real, very soon.