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Let's look at the upside scenario of your "I'd hardly call it small change" musings.
Imagine you had smartly sold on the way down planning to buy back in the target zones so clearly laid out on the carefully crafted TA chart.
Of course you still have a core position in Anavex, which could be perhaps half of your maximum Anavex exposure and the other half ebbing and flowing as trading shares. Let's say this now means 10,000 core shares held and the other 10,000 sold on the way down from your favourite resistance zone.
You have minimised your losses, but making them real, but soon you will have your max position back and cheaper. Others with a comparable 20,000 share position who just held on tight would have lost, on paper that is, say a 1/3 of the value.
Then one morning when you least expect it, news hits the screen: "Anavex inks licensing deal with Biogen for MS securing $1B in upfront payment and 30% of future world-wide revenues". BAM!
The PSS skyrockets to $43 in a manner of hours. Those who sold their trading shares would still be quids in by a great margin, but in this fictitious scenario only half as much as those who just held tight ($430K versus $860K, when starting from a high of $124K for the position assuming PPS topped at $6.2), minus of course the realised loss from the trading shares.
All depends on your personal risk management and investing style. Personally, I accept the risk and fun of very volatility Biotechs, which are often associated with binary outcomes. I never short (don't like gearing or the risk of loosing more than I put in), but try my best at doing DD on the science, management and finances. Make sure I have a balanced portfolio constructed so that a couple of winners easily makes up for the losses of the rest (obviously more than 2 out of 10 is desirable).
I am not saying one approach or the other is long term better. Perhaps adopting the core position with cleverly executed trading shares scheme can make for a less volatile ride. Maybe doing good DD and just holding is best and doesn't glue you to the screen, so long as you don't loose sleep over looking at your large portfolio value swings.
Has anyone done the research and written a thesis on the comparison of these strategies?
I do agree that the raw PK/PD data is not of much use to the average investor, just curious that Missling has said it would be released.
Agree that the PK/PD data will hopefully soon be seen as the input to a confirmatory trial in Alzheimer's and the other known and expected indications.
It is also true that Missling has stated verbally and in presentation that the release of PK/PD data is in fact next on his todo list, awaiting a tick, tock...
You could of course be right that the results, despite the apparent 'breadcrumbs', are not superior after all.
Although I understand Missling's argument that the Rett trial may be the fastest and most cost effective route to market, I've always thought it a risky strategy too. If that trial fails I should think the game is pretty much over as far as share price and funding is concerned.
On the other hand rationally it makes sense not to prolong a looming failure and indeed also, as many will be hoping (including me), to aim straight for the moonshot.
Only more time well tell!
All true, it doesn't however mean we won't eventually get of all that.
Do you actually think everything has just suddenly fallen off a cliff and won't happen at all?
I am pleased and honoured to have passed the F1ash semantics test
Correct! It could be done, but would be a foolish waste of money, time and energy just to enable a price war on A2-73 for Alzheimer's in years from now.
That competitive form of A2-73 would of course need to an approved one. There is no patent issues preventing that, but a mountain to climb getting it approved first.
At any rate despite all sorts of opinions, some FUD like, the combo patent is good and necessary news. It won't make the PPS rocket, but helps to not make it fall.
The FDA does not enforce patent rights. One engages expensive lawyers to seek patent rights enforcement through the courts and in many cases out of court settlements.
We need to separate the various marketing exclusivity rights that the FDA can grant, and perhaps also enforces, from patent protection.
The original trial protocol had readout at 31 weeks, I believe. So one could argue that the per protocol data has been released. It is also based upon this data that Anavex claims the FDA has been providing guidance for the long awaited P2/3 trial. In other words as far as we can tell, the FDA has not required further data in order to potentially agree to a P2/3 trial.
In this context we are not owed further data, except for the fact that Missling has promised extension study data as it becomes available...
We then speculate that ever since the extension study has continued to provide data that can further inform the definition of the P2/3 trial design and according to Missling minimise the risk of failure.
It seems then our best hope is that the wait is all for good reasons soon to be revealed...
IMHO, no not by the combo patent. See my other posts on this.
Patent rights and various marketing exclusivity rights granted by the FDA should not be confused. Each of course can give valuable revenue protection.
Yes all that is true. Special marketing exclusivity granted by the FDA, but separate from patent rights. I haven't investigated whether similar marketing exclusivity can be obtained in the EU and Asia etc.
The following is my understanding, which could wrong!
The A2-73 patent has expired and had it been approved and marketed with commercial value, the drug could now be subject to generics. Alas, in all it's 20 years of patent protection it has not been approved for any indication and has made no money for the owners. So not much risk of generics at this time.
The molecule on it's own of course is no longer novel and thus no one, including Anavex, could ever again obtain that same patent protection.
Given novelty and utility, a combination of A2-73 with some other drug e.g. Donepizil could be patented as is the case with Anavex Plus. This does not extend the patent protection of A2-73 on its own. Only the combination drug enjoys protection.
Other alternatives include patenting new uses e.g. slow release or new indications, not previously disclosed in the original patent or elsewhere. This, not withstanding the marketing exclusivity that may be granted by the FDA for each new indication the drug may be approved for.
Finally, someone could in principle develop some other novel and useful combination of the A2-73 molecule with another drug not disclosed in the Anavex Plus patent. However, again as A2-73 has yet to be approved for any indication, it stands to reason that this is unlikely to happen, at least in the foreseeable future.
Once A2-73 might be approved in one or more indications, presumably the game could be on trying to come up with and patenting other combination drugs to include A2-73 for various indications. However, if the Anavex Plus patent is well crafted it could prove a difficult and expensive route for the competition to steal some Anavex revenue.
Now with this background of course Anavex could and likely will seek to obtain marketing approval for A2-73 on it's own and market it as such.
Not sure if the combination drug will need to go through any trials and approval, but presumably not as both drugs would already have approvals.
So altogether the combo patent puts blockers in the way of the competition even though A2-73 on it's own is not protected.
Does that make sense or am I just completely misguided?
As per the references I provided in a previous post, I believe it must be one pill delivering exactly the novel combo utility that the patent is granted for.
Can you provide a link confirming that?
Seems odd to that a patent granted on a novel combo (FDC) would protect A2-73 on its own as if it's patent had not expired.
My take is no, but probably no harm in dragging a bit of Donepizil along.
Likely no PPS upside from the grant of the patent, but significant downside had they not secured the patent.
Anavex Plus patent
Fixed-dose combination drugs (FDCs) are formulations that contain two or more active ingredients in a single dose [11]. According to the FDA, “two or more drugs may be combined in a single dose when each component makes a contribution to the claimed effects, and the dosage of each component (i.e., amount, frequency, and duration) is such that the combination is safe and effective for a significant patient population requiring such concurrent therapy”
In the US, if a FDC is novel, non-obvious, and useful, it can be patented and the exclusion of competitors from the market can be enforced (Fig 2). In this case, the sponsor company is able to add patent and exclusivity time to the combination of individual products included in the FDC, for which patents and exclusivities may be expired or close to expire.
Nice find! More breadcrumbs and just perhaps a potential Biogen/Anavex PR before?
It is perplexing why, when later data is available and 57 week data is already published, that Anavex still quotes 31 and 41 week data.
Ah yes, I was too quick to think Bas's answer was plausible. I did notice slide 22 before I posted, but then forgot.
So now remains the answer to F1ash's question; why then in May 2017 did Anavex still quote the 31 and 41 week data and not the later already presented later 57 week data?
That could be, yes.
Check the heading you are quoting from "Aims"!
Then look at the "Conclusions"!
At CTAD December 2016 MacFarlane presented 9 and 12 months data, but why they chose to record 31 and 41 week data in the May 2017 SEC filing is left to guessing.
Could it be that, as per the CTAD December 2016 slide 29, the 31 and 41 week MMSE scores are better than the 57 week point? Although on the same slide the 57 week ADCS-ADL score appears ever so slightly better.
Another thing that puzzles me about slide 32 "Examples of MMSE "Strong" patient Responders" in that same Dec 2016 presentation, is the jumpiness of at least the light blue and faint orange results.
Altogether it is true that those 6 strong responders are all improved at 57 weeks over their baseline. The light blue graph in particular looks odd starting with a 20 baseline score and rocketing to 26 at 41 weeks, to then crash back to 20 at 52 weeks and end at 25 at 57 weeks. Also, the faint orange graph has a baseline of 20 rising to 22.5 at 31 weeks, to then fall to 19 at 41 weeks and ending at 22 at 57 weeks.
Begs the question how those graphs continue even just beyond 57 weeks?
Then there is the disappeared infamous 15-months abstract, where we could briefly read the following:
Conclusion: The safety of ANAVEX2-73 was assessed and MTD was determined. Despite not optimal dosing, both cognitive and functional performance is sustained over at least 12 months, suggesting that the effect of the compound does not seem to worsen AD symptoms with repeated dosing. In a progressive disease this is considered a positive outcome. The data support further clinicla development of ANAVEX2-73 and preparation for a larger confirmatory study is underway.
At least the dude is where he belongs. I doubt Missling would risk it all and face jail. Equally hard to accept that the advisory board, FDA, Australian Ethics Committee etc. could have been duped or are colluding to make a dime.
Still we need P2/3, Rett and PD trials to get going and hopefully prove the case, at least better than SOC and with continued safety...
I was invested in $STEM Stemcells Inc. with a very small trial in spinal cord injury, which is regarded one of those afflictions where placebo effect just does not occur.
The company reported astounding data and even had a video with a patient showing what he could do after the treatment.
Two weeks later the company announced that on closer look the data did not justify further trials and where winding down operations. The stock tanked and Stem got bought by $MBOT, an Israeli company eager to list on the Nasdaq. Stock skyrocketed to then falter again. No SEC investigation and no one in jail - beats me!!!
I hope you are right for the sake of folks with Alzheimer's etc. and for those of us that may avoid it, and finally for our investment.
Anavex would have to be the most heinous scam if all we have been told and hinted at by the company does not mean an interesting period ahead...
Sounds good to me, except:
If those super responders are just optimized and DZP naive, then I won't call them super responders...I will just call them responders. I would expect everyone in that case who will be on the optimized dose and without DZP to perform just as well.
Go ANAVEX - GOD'S Gift to HUMANITY!!!!!!
Biotech broadly down today!
I don't think the sentiment Macfarlane expressed was that there was no significant improvement on the rating scales, but rather that he for the first time is seeing data translated into real improvements to patients.
I am sure if you are someone, like Macfarlane, who has been working with Alzheimer's patients and various drugs for a long time, you know real improvement when you see it!
I imagine many of us here hold $AVXL positions as large or larger than the bottom half of the institutional owners.
Fintel Institutional and Fund Ownership
Indeed, so long as you don't fall into the trap of selling the pain is only virtual.
Also the bid/ask accumulative size at anytime is mostly below 10,000 shares. A panic avalanche, I think, would see greater instant bid/ask volume depth.
The overwhelming part of the volume today is from 100 share trades. This is a concerted effort and not panic selling!!!
from every other biotech.
Yes baby biotechs is a gamble of sorts. Do thorough due diligence. choose the ones that seem to have big potential, keep a diversified portfolio, expect many to go wrong and hopefully do exceptionally well on a few...