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Re: Your question
Way too many variables to hypothesize! They could have applied and were denied. Perhaps long ago, before Missling arrived. Focusing on AD could make lesser indications out of scope. Interest from outside sources can guide pathways...etc, etc.
It is one of the things that is generally outside of the shareholder info, specific actions that are better kept under wraps by the co. We just don't know until an announcement.
Likely there is an outside influence on the Rett syndrome developments. A3-71 in an OI is likely the quickest way to get it to market, where obviousness and changing off-labeling rules will have it prescribed for other inds. Yes, a doctor can essentially prescribe anything for anything, it's whether 1 or 10,000 are doing it that causes issues.
This site has lots of info:
http://www.orpha.net/consor/cgi-bin/OC_Exp.php?Expert=778
If the co has meet with the FDA and the guidance that they received was weighed heavy towards safety info and providing expanded PK/PD data for a "we got your P3" type trial, IN LIGHT OF APPARENT EFFICACY AT 12 WEEKS, we have a home run. The FDA will be indicating that long term safety is the only real hurdle to a new SOC.
If we are not getting the 12 week update until May and it is very promising we will probably see a RPRX-type move. $12 - $14
This is certainly looking like some partnerships will be developing, if nothing else!
BUMP! Reyeton's post
GO LITTLE REDHEAD!!!
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Well I am starting to sell all those threes I grabbed the other day. Get my money back and kick GC to the curb! Could have snatched a milly .06s yesterday when someone had the days vol offered up. Pity...but also just asking to be left with the bag if you do that.
Stinky pinky gutter play is all this is now. Hope I can chuck the grimy trash before the next dump...or the BK news
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Prolly what put him in his fighting mood. How dare the FDA think A3-71 is anything more than snake oil!
Material event. Disclosed. Move along...maybe some 4's today?
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Hmmmm...UCB. Kyoko Koshibu, research fellow - Queensland Brain Institute
http://www.zoominfo.com/c/Queensland-Brain-Institute/61555409
Very familiar quotations and text, yet a good summation of the compound status. A UCB connection is very interesting indeed. Thanks George!
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The board says, "Ugggh!".§
Very nice site. I still fail to find info regarding "Anavex will be filing for a dismissal based on the proposed joint filing for proposed schedule filed today."
The regurgitation of public filings is of little meaning to MB readers without subsequent translation. I am not an attorney, so cannot provide. I would if I could.
I do know, firmly well, the position merit-less CASs have in the scheme of young biotech development. Our CEO has his legal team properly entrenched for litigate superiority.
AAP
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ed- Yes, settle and move on is best for speed bumps.
How about Missling coming into this with a suitor all planned-out...any weight?
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Do you have any links or text...be more specific? As of the public info:
https://www.pacermonitor.com/public/case/10241340/Cortina_v_Anavex_Life_Sciences_Corp_et_al
What's going on Counsel?
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That's quite a leap. What's your guess and at what time? §
The low threes to sixs did offer some scraps. Trading between the conversion dumps is all that's left. I've recouped $16K of $48K. Friggin' 'roucherag' CEO!
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It's been trading some. 50 and 200DMA are getting tighter. Could be in play soon. Hope you long boys are ready to agv down at the bottom!
GLTA§
This is the $AVXL train peeps. let's stay on track.§
Like who? I agree with George's logical line of thinking (which, yes, is not to be confused with fact) in that if we were an easy target, we would have been bought by now.
The CEO is a neuroinquisitist from the financial side of the table. I bet you $1 he heads up this company when he's 62.
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Oh...sure. If the company releases good 12 week data accompanied by some juicy PK numbers this stock could jump big. I expect some news this week. Did not think it would be today, but it will come at that 8:00 post time and you know how that is...
Any online POV article without a comment section is worthless. Mr Campbell's piece was especially so. No, Grandpa wouldn't touch AVXL. Gotcha...
ANAVEX 2-73 and Neuroinflammation:
“Our trial will use an adaptive design because that approach enables a certain degree of flexibility, for example, in determining the final sample size for a trial. Regulatorily acceptable adaptive designs are attractive in late-stage development because they can potentially help accelerate the process, which is very important, given the long treatment periods required at this time for disease-modifying AD drugs,” Dr. Margolin said.
https://alzheimersnewstoday.com/2015/11/17/neuroinflammation-alzheimers-therapy-target/
Anavex Encouraged by New Scientific Data Revealing Positive Role of Sigma-1 Receptors in Brain Injuries
Again...already there.
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The boy was worried after the 1st when his shares he thought were out of reach at 5.14 got snatched. Missed the pop to 6 but had the 5.10s dropped in his lap last week. Friday was an easy exit, and a little patience today and there they are again. He's getting good!
A's AVXL
16/02/22 +6,084 3.85 -$23,424 +6,084
16/03/11 -6,080 5.62 +$34,169 +4
16/03/14 +7,348 4.65 -$34,168 +7,352 +$1
16/03/14 -7,348 4.92 +$36,153 +4
16/03/15 +8,179 4.42 -$36,151 +8,183 +$3
16/03/30 -8,150 5.12 +$41,728 +33
16/03/31 +8,657 4.82 -$41,728 +8,690
16/04/01 -8,600 5.14 +$44,204 +90
16/04/07 +8,668 5.10 -$44,204 +8,958
16/04/08 -5,287 6.18 +$32,674 +3,671
16/04/11 +6,013 5.42 -$32,590 +9,684 +$84
Got rid of my bag full of 3MM .0002s!
9 months later, 1068%
Bye-bye salt...
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Anavex 2-73 and Rett Syndrome...and Sanofi
There are many genetic-based diseases detectable through prenatal genetic screening. Rett Syndrome is one of them. Someday we will be able to economically screen all developing fetuses for genetic abnormalities.
If A2-73 is able to rescue normal MECP2 function it may act as a vaccine if administered in early life. It would not be alone in a lineup of compounds poised to act in that capacity, so don't pee your pants, yet.
The 1:10,000+ prevalence ratio makes running a clinical trial next to impossible. New technology is changing that:
http://www.clinicalleader.com/doc/how-rare-disease-know-how-can-shape-big-pharma-clinical-trials-0001
Missling worked in finacials at Aventis which was bought by Sanofi...which has mostly stayed out of the AD space, until recently supporting Yumanity Therapeutics.
http://www.forbes.com/sites/luketimmerman/2016/02/10/fidelity-biogen-sanofi-join-45m-bet-on-alzheimers-and-parkinsons-startup/#2d066f833b4f
Sanofi might like A2-73 in their rare disease portfolio for Rett Syndrome. It is likely out of their reach at this point.
§
The company may be using the grant money provided by AU to extend the PK/PD analysis as an "eligible expenditure".
Anavex's very small molecule, orally-available compounds readily cross the BetterBusinessBureau, attributing to their potency, safety and tolerance. A2-73 is a type I Prodrug, metabolizing into AE37met. A3-71 is an active metabolic compound that undergoes no metabolism in the body. It is completely safe at 50,000 times the minimally-active dose of 10ug(that's MICROgrams) per Kg body weight, or around 700ug for a 150lb human. 1000ug = 1mg! So the toxicity threshold is 35,000 milligrams.
More good reading. Don't try too hard to understand it, just give a read-through.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1201315/
Problems with digestive absorption/metabolism often cause the necessity of intravenous, topical, olfactory, etc. administration of drugs. Insulin being the poster child, generally speaking. Oral availability is a strong attribute.
I think this week will be exiting. Perhaps we should watch for Dr Macfarlane presenting here? Looks like a proper venue. Maybe Dr Z will pop his head out!
Clinical Trials Plenary Session
"One of his most valuable strengths is the knowledge of applying population pharmacokinetics to analyze variability in drug concentrations between patients and hence provide additional safety details often requested by regulatory authorities."
GLTABDITG!
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Splendid news today for A3-71!
A big congrats to Ms Capiak and the team. Frontotemporal Dementia (FTD) is the most severely mass-degrading of the CNSDs. Protection from loss of brain mass is one of the hallmarks of A3-71, so perusing this indication is a....er....no-brainer?
First, lets revisit an old link:
http://www.alzforum.org/news/conference-coverage/taking-aim-m1-old-hat-or-new-target
Then go over the poster:
http://anavex.com/files/2016-03-14_AV3-71_AF710B-AD_Springfield_poster.pdf
It seems brain mass preservation was fairly evident in the big, old rats.
FTD. It may prove the quickest way to market. Any 3-71 news is fabulous news. Sorry scottsmith, A2-73 can go suck an egg, there.
Heptares sold. Little Orphan Annie-vex did not!!!
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Oh yes...water-logged math $400M on the value. That would be rich. $250/sh would be obscene.
The 12 week data will have to come. The trial extension tells me it is not bad, rather being given an extended look. We shall see.
XenaLives: Haven't gotten a supplement yet!
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I will say this. It is amazing the valuations put on some companies in the same space, when you look at those figures. I can only conclude that our management has passed on some very lucrative offers in light of the science.
$10B or $40/sh would be acceptable given the parameters, yet our company structure does not fit the profile of that which would succumb to an easy exit. The CEO really makes all the difference here, if you know his fundamental desires vs the founders intentions.
The current SOCs are far from disease modifying. That really is the holy grail. I don't know if our compounds are it...I doubt it. But I believe the FDA is taking a stance where drugs with acceptable safety profiles will be approved and the physician and their tools will be allowed to find the most appropriate courses of treatment. It is the 21st Century, after all.
The Board would settle for no less than $100/sh...how about that?
§
If the compound(s) is truly disease modifying...it's all over. A new SOC will mean $20/sh easy and that would make my capital investment just disgusting..."know what I mean?"
From Mr Renauer's piece:
"At the end of the 52-week follow-on study with capsules, Anavex will test the patients for cognitive impairment. Without a control group for comparison, they'll probably be positive, but the FDA won't be interested in any data from that trial except the drug's safety profile."
Safety profile alone could mean a new SOC.
§
Heptares sells out for $3B
"M1 selective compounds are in development for the potential treatment of symptomatic cognitive deficits in Alzheimer's patients, with the potential upside of better tolerability and a more pronounced effect compared with available treatments. M4 selective compounds may provide a novel approach to treat the neurobehavioral symptoms (psychoses) associated with Alzheimer's disease and related neurological disorders, through a different mechanism of action than available antipsychotics. Combined, dual M1/M4 agonists may be able to treat both cognitive impairment and neurobehavioral symptoms."
That is us. A2-73 is highly selective to the M-1. I have not found anything to indicate it's selectivity for the 2-5 subtypes but I believe it is an agonist to the M-3 and antagonist to M-4 and M-5. BP is on the track, but following far behind us!
"Muscarinic receptors are G protein-coupled receptors (GPCRs) found in multiple tissues. Until now, attempts to develop medicines that target M1 and M4 receptors have been unsuccessful because of side effects caused by the activation of M2 and M3 receptors. Selective M1 or M4 agonists that do not activate M2 or M3 therefore are highly sought after, and expected to address blockbuster markets"
Read the following on A3-71 and compare that to the above statement. Without a description of A3-71's effects on the other M receptors it would seem from the compound history that these critical affinities are achieved in this one as described.
"We previously developed orthosteric M1 muscarinic agonists (e.g. AF102B, AF267B and AF292), which act as cognitive enhancers and potential disease modifiers. We now report on a novel compound, AF710B, a highly potent and selective allosteric M1 muscarinic and s1 receptor agonist. AF710B exhibits an allosteric agonistic profile on the M1 muscarinic receptor; very low concentrations of AF710B significantly potentiated the binding and efficacy of carbachol on M1 receptors and their downstream effects (p-ERK1/2, p-CREB). AF710B (1-30 µg/kg, p.o.) was a potent and safe cognitive enhancer in rats treated with the M1 antagonist trihexyphenidyl (passive avoidance impairment). These effects of AF710B involve s1 receptor activation. In agreement with its antiamnesic properties, AF710B (at 30 nM), via activation of M1 and a possible involvement of s1 receptors, rescued mushroom synapse loss in PS1-KI and APP-KI neuronal cultures, while AF267B (1 µM) was less potent in PS1-KI and ineffective in APP-KI models, respectively. In female 3xTg-AD mice, AF710B (10 µg/kg, i.p./daily/2 months) (i) mitigated cognitive impairments in the Morris water maze; (ii) decreased BACE1, GSK3ß activity, p25/CDK5, neuroinflammation, soluble and insoluble Aß40, Aß42, plaques and tau pathologies. AF710B differs from conventional s1 and M1 muscarinic (orthosteric, allosteric or bitopic) agonists. These results highlight AF710B as a potential treatment for Alzheimer's disease (e.g. improving cognitive deficits, synaptic loss, amyloid and tau pathologies, and neuroinflammation) with a superior profile over a plethora of other therapeutic strategies."
http://www.ncbi.nlm.nih.gov/pubmed/26606130
This is more validation for us. The little redhead who will not be bought!
GOT PIPELINE?
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Notice how he makes this pick right after AVXL overtakes the S&P500
Caps Pick
crenauer made a pick in CAPS. 10:26 AM (03/05/16)
ANAVEX LIFE SCIENCES (AVXL) will Underperform the S&P 500
Hit piece fails to mention the $150M shelf prospectus. At $5.50 that would take the O/S to 51MM...whoopie-doo. What could Anavex and it's pipeline possibly do with $150,000,000? Go to market?
Means ziltcho when BP wants to put a $10B value on her.
Nice try fools...we'll watch the chart.
§
Here you go pal...
http://www.anavex.com/
Get some coffee and get reading. See you in a couple days.
§
ps- I think it has something to do with preloading the electron base in the sodium ion channel before muscarinic activation of the selective sigma attenuation...but you tell me.
The 20¢ covered spread trade has been supremely optimal!
The TA trading is beautifully predictable.
GLTA
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Rational thinking says BK will negate the necessity of annual meeting, capital adjustments, etc, etc.
TOXIC FLOOR-LESS CONVERTIBLES
Scraping the bottom trade here in between dumps is sorta sickening. Like that queasy feeling you have after getting off the nauseating carnival ride to gain your kewpie doll. The memory brings back that sickly feeling long after the kewpie doll has vanished.
Stay real.
§
It seems some people do not understand the implications. They extended an adaptive P2a to three years! This means they can change the modeling structure and use extended PK/PD data to design a more successful P3. PK/PD analysis can be very expensive, and if they are using evolving data characteristics to design the next phase, expect it to take a while and cost a lot of money...~$3000/pt.
http://www.mrc-bsu.cam.ac.uk/wp-content/uploads/4_Bogacka.pdf
Dose response becomes very important when the drug is intended as a long term, disease-modifying treatment.
The cognitive and functional data is in and has been. That is easy...all computer compounded. The PK/PD analysis, depending on the scope, takes quite a bit longer and as has been repeatedly pointed out:
"The details relating to pharmacokinetics and pharmacodynamics are being fully analyzed so that there can be no doubt as to the cause-effect relationship of the 12-week efficacy data and this must be completed before it can be released."
The presentation of full blood analysis coupled with the 12 week C&F data will help solidify the results in investor's minds.
The May event should be the 26 week results, where no PK/PD data will be along to support. That will be our turning point.
Let's let Missling engineer this train. He's done Ok so far.
§
New funs...
2.8MM $VDRM
275KK $GNOW
§
Worked well for the boy...
16/02/22 +6,084 3.85 -$23,424 +6,084
16/03/11 -6,080 5.62 +$34,169 +4
16/03/14 +7,348 4.65 -$34,168 +7,352 +$1
16/03/14 -7,348 4.92 +$36,153 +4
16/03/15 +8,179 4.42 -$36,151 +8,183 +$3
16/03/30 -8,150 5.12 +$41,728 +33
16/03/31 +8,657 4.82 -$41,728 +8,690
Word...nice close, beer? (woops...to early)
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So it is a mix of donepezil and whatever else, and they are trying an ascended dose up to 60mg MTD? I believe the MTD for donepezil is 23mg? The study calls for pre-dosing of the donepezil arm at 5-10mg/day.
I went to compare to the P2a A2-73 study and was surprised to see no mention of donepezil, Aricept, etc. Other than the "...and to explore the relationship of ANAVEX2-73 as add-on therapy to AD standard of care."
I could have sworn there was something about 'stabilized on 5 or 10mg donepezil' in the eligibility section. I am starting to believe more that the add-on to donepezil was just a best scenario precaution as indicated by the preclinical models, which were comparable to the SOCs. The efficacy shown beyond the donepezil curve will negate it's inclusion in the outcome results. If the MTD is 50-60mg and the dose response maxes at 30-45mg with long term efficacy, we got a winner.
I would like to hear opinions on the rejection of the 12/522,761 patent and what we could expect from this once 13/777,471 is published.
TomP1: "Anavex views the most recent Office Action as within the ordinary course." Meaning, "We have a competent patent attorney and will secure the necessary IP in due course"?
GLTA
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We can appeal to the board or file Request for Continued Examination (RCE). We may be leaving the combo drug hitchhiking endeavor as well, as others have pointed out, if A2-73 proves effective past 6 months.
I think this will be our newly resurected MOU patent:
U.S. Pat. App. No. 13/777,471
“Sigma-Receptor Ligands with Anti-Apoptotic and/or Pro-Apoptotic Properties Over Cellular Biochemical Mechanisms, with Neuroprotective, Anti-Cancer, Anti-Metastatic and Anti-(Chronic) Inflammatory Action”
Not yet published
Identical to parent U.S. Pat App. No. 12/522,761 / U.S. Pub. No. 20100069484 (ANAVEX 2-73 Composition & Method of use)
If A2-73 has efficacy past 6 months dosing, donepezil will be out of the equation and we will be on our way to Disease-Modifying classification.
Nice find EPC presentation!
Surely interesting powerwalker!
Here is Chase Pharmecuedicals, headed up by Allergan-ex Douglas Ingram. Testing CPC-201 which is a combo of donepezil and an undisclosed pharmaceutical.
http://www.chasepharmaceuticals.com/
https://clinicaltrials.gov/ct2/results?term=Chase+Pharmaceuticals&Search=Search
https://clinicaltrials.gov/ct2/show/NCT02549196?term=Chase+Pharmaceuticals&rank=1
http://www.biocentury.com/products/cpc-201
I could not ascertain what, exactly, this undisclosed pharmie might be. The MOA sure sounds familiar. This is a dose triation study to determine the optimal dose for synergy with donepezil?
"The company is currently completing a Phase 2 trial of its lead program, CPC-201, in patients with mild to moderate Alzheimer's disease. CPC-201 pairs a patent-protected, fixed-dose combination of one of the few pharmaceuticals proven to improve cognition and behavioral symptoms associated with Alzheimer’s disease, donepezil (an acetylcholinesterase inhibitor or AChEI), with a peripherally acting cholinergic blocker. While AChEls are the current standard of care for Alzheimer’s disease patients, side effects limit tolerability and use in optimal doses. Chase believes that CPC-201 will improve tolerability by reducing or eliminating the dose-limiting side effects of donepezil, allowing significant increases in dosing and resulting in significantly improved efficacy."
Here are the patents, most recently 03/08/16.
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=0&f=S&l=50&TERM1=Chase+Pharmaceuticals+Corporation+&FIELD1=&co1=AND&TERM2=&FIELD2=&d=PTXT
If I read this correctly, all of these compounds are included in the preparation, making it quite a cocktail:
"Thus, it is another object of the present invention to provide a pharmaceutical unit form which comprises
(a) a non-anticholinergic antiemetic agent; and
(b) an AChEI
in admixture with a pharmaceutical carrier.
In the pharmaceutical unit form of the present invention, the non-anticholinergic antiemetic agent Component (a), is present in an amount of from 50% to 300% of the amount of the said non-anticholinergic antiemetic agent contained as a sole active ingredient in the currently used brand or generic drugs.
According to a preferred embodiment, said Component (a) is a non-anticholinergic antiemetic agent selected from the group consisting of (a1) 5HT3-antagonists, (a2) DA-antagonists, (a3) H1-antagonists, (a4) cannabinoids, (a5) aprepitant and (a6) casopitant.
The pharmaceutical composition to improve the treatment of human dementias of the Alzheimer type according to the present invention may comprise a mixture of a non-anticholinergic antiemetic agent, Component (a), and of an AChEI, Component (b), wherein Component (b) is present in a quantity sufficient to maximally alleviate disease-associated neurobehavioral symptoms and wherein Component (a) is present in a second quantity that reduces adverse effects that would be caused by the AChEI if administered without the accompanying non-anticholinergic antiemetic agent.
Said amount of Component (b) sufficient to maximally alleviate disease-associated cognitive and other neurobehavioral symptoms is from 1 time to 3 times, advantageously 1.5 times to 3 times, preferably 2-3 times the maximal dose contained in the currently used brand or generic AChEIs.
As to Component (a), typical 5HT3-antagonist non-anticholinergic antiemetic agents (a1) are the compounds described in EP 191562, in particular ondansetron and pharmaceutically acceptable salts and solvates thereof; the compounds described in EP 200444, in particular granisetron and pharmaceutically acceptable salts and solvates thereof; the compounds described in EP 266730, in particular dolasetron and pharmaceutically acceptable salts and solvates thereof; the compounds described in U.S. Pat. No. 4,789,673, in particular tropisetron and pharmaceutically acceptable salts and solvates thereof; and the compounds described in EP 430190, in particular palonosetron and pharmaceutically acceptable salts and solvates thereof.
Typical DA-antagonists (a2) are domperidone and pharmaceutically acceptable salts and solvates thereof such as the maleate; chlorpromazine and pharmaceutically acceptable salts and solvates thereof such as the hydrochloride; prochlorperazine and its salts and solvates, particularly the dimaleate and the dimesylate; promethazine and pharmaceutically acceptable salts and solvates thereof such as the hydrochloride; and 4-aminosalicylamide derivatives such as metoclopramide and pharmaceutically acceptable salts and solvates thereof such as the hydrochloride monohydrate, bromopride and pharmaceutically acceptable salts and solvates thereof such as the monohydrochloride or the dihydrochloride monohydrate, alizapride and pharmaceutically acceptable salts and solvates thereof such as the hydrochloride, and clebopride and pharmaceutically acceptable salts and solvates thereof such as the malate and the hydrochloride monohydrate.
Typical histamine H1 receptor antagonists (a3) are meclizine (meclozine) and pharmaceutically acceptable salts and solvates thereof such as the hydrochloride monohydrate; promethazine and pharmaceutically acceptable salts and solvates thereof such as the hydrochloride; chlorpromazine and pharmaceutically acceptable salts and solvates thereof such as the hydrochloride, prochlorperazine and pharmaceutically acceptable salts and solvates thereof such as the dimaleate, the dimesylate or the 1,2-ethanedisulfonate (1:1) (edisilate); hydroxyzine and pharmaceutically acceptable salts and solvates thereof such as the dihydrochloride or the 1,1'-methylene bis(2-hydroxy-3-naphthalenecarboxylic acid (pamoate) salt.
Typical cannabinoids (a4) are nabilone and dronabinol.
Each of said typical non-anticholinergic antiemetic agents is present in the pharmaceutical composition, as Component (a), in an amount ranging from 50% of the minimum amount to 300% of the maximum amount of said typical non-anticholinergic antiemetic agent contained in the corresponding, currently used generic or brand drug for its antiemetic indication in IR form."
To me this makes A2-73 sound like it is still further upstream in the intervention of the pathology. More confirmation on the MOA of our compound(s)...which are in human trials right now! Lots of private dollars being thrown at studies who's results we could be forbearing.
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I agree. Lilly's "well you gotta approve something!" stance may well be met with "we will...and it's called ANAVEX".
One thing I differentiate is the disease stage importance. These plaque-clearing drugs being tested on mid to late stage patients are not very effective. I don't understand why more developers have not attempted to start their drugs on mild cases and follow progression for at least 2 years, given the disease's growth profile. For the most part, it seems, safety has been the biggest problem with the different MOA (especially monoclonal antibodies) drugs. If the long term safety of A2-73 remains and we don't see a Vioxx-type development, we could be in luck. There is no precedence to compare to if these Sigma-1 compounds become a new class of CNSD drugs. It would be history...yes, like penicillin or aspirin.
The "holy grail" is indeed what it is. Not only are we working on CNSDs, but our compounds begin to delve deep into the world of apoptosis. The human clock. Medicine's 'final frontier'.
I think there are important connections here between the scientists, founders and a very astute CEO who knew what he was looking for. A combination of factors that is not possible within the framework of BP. A true underdog.
It could be that A2-73 is showing an improvement in function beyond that of the cognitive effects. Further trials designed to place emphasis on that could well have the reverse effect on approval as what was stated in the article.
Looks like another biotech beat down today. There's fresh powder in the back country...tootles!
GLTA
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ed- Yikes! Stink bids @ 4.65....drop 'em?