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Occam's Razor.
A third doctor, this one in NYC, came forth yesterday with very much the same conclusion.
Yeah, but we're not going to close at that price. We're not even going to close at .03.
I'm long and happy to hold with this company; however, if this were going to be resolved quickly, then it would have happened. Lawyers are involved, and that means a snail's pace. Put the ticker on watch and forget about it.
Great link. First time I've actually read the site. The bullet points seem as if they were designed with 2-73 in mind. I don't think there will be an announcement declaring the company's seek official fast track approval, and I think that's good because it would provide an opportunity for shorts to attack, as well as leave Missling open to law suits alleging he was pumping in the event fast track was not allowed. So, patience remains the ticket; that said, my optimism arrow has moved several ticks in a positive direction.
I fully expect SP to shrink in December because of investors electing to take a tax loss and figuring they will be able to get back in before big news hits.
No, I don't think the market had already priced in these extensions. And on what basis would you suggest that? You're saying you anticipated this? Sorry, not buying.
And what does any of this have to do with people suffering? Are you suggesting that 2-73 is a proven commodity, but Missling is deliberately keeping it from approval?
Nearly all of those critical of 2-73 have consistently posted snide commentary about what the market thinks about this or that with respect to the company and its stock. Today, these same critics have derided the company for the trial extensions. Well, by their own logic, these trial extensions have had zero effect on the company or investor confidence, because the SP didn't suffer in the least. Obviously, the market does not agree that the extensions signify anything ominous.
And if resolved as we anticipate, what is your expectation of immediate SP spike? I'm asking you because I think you are correct in this taking months, which means you are not a rah-rah guy, but have a measured opinion.
I readily admit I'd have done things differently if I'd been wiser and/or less greedy. When I first got invested (Was it 4 or 5 years ago? It was before the RS.), I was a perfect example of a dirt farmer stampeding to the gold rush! With even a modicum of investment wisdom, there were a couple of absolutely unsustainable, unreasonable runs that doubtless enabled lesser fools to make good money and then run on the house's dime, while having increased the amount of shares owned. Lesson learned.
That said, I happily loaded a lot of additional shares late last year and early this one when the price was sub $2, and I have no regrets about that. In other words, my faith in the science -- which is, at this point, a reasonable gamble -- remains in tact. However, that faith could have been maintained at a much cheaper price, and the money I've tied up here could and would have certainly been put toward a more profitable endeavor. Live and learn.
Buying. Without substantive news, this will go further south, and coupled with EOY sells for tax purposes I believe we could easily see sub 2$. If that happens I'm buying more. If your trust the science, this a "long's" wet dream.
I would like nothing more than for you to be correct. I'd be pleased to eat humble pie.
I'm not trying to scare anyone. I have a decent position in the stock and bought more on the first pronounced dip when the sale was put on hold. I do not see this running to a dollar, but rest assured, I'd be thrilled if it did. I also think it likely to be a few months before anything happens, and there is no guarantee things will be resolved in our favor.
It appears confidence has fallen dramatically. I certainly think this stock has a real and substantial chance to recover nicely; however, to think it would happen quickly was delusional. Moreover, it WILL NOT go to $1, as some on this board have relentlessly and ridiculously claimed. At least not before a reverse split; that is, if the present mess is resolved in our favor.
Should approval occur -- whether it be provisional out of P2 or after a P3 -- I'd love to hear opinions on what the SP will do immediately? After a month? After one quarter? A year later?
Zena, have enjoyed and appreciated your DD, but I don't think I've ever seen you speculate on a SP. If given an indication for AD, where to we go? For Rett? For PD? For all three? Have you a guess?
Easily followed, Tom, makes perfect sense!
Georgejjl, that notion is enormously important and does not get the attention it warrants. The neurologist community, in the US and abroad, is much more attuned to trials of new drugs that show some promise for AD and PDD (as well as MS)than is the investment community. That's what makes an indication for Rett so important. As patients are desperate for treatment, doctors are desperate to help them. If approved for Rett, the problem will instantly become supply, because demand is going to increase exponentially, month to month as doctors prescribe a drug that may work and has a good safety profile. In my view, phase 3 trials will be rolled over for phase 4. Money will pour in...think, catch a rising (rocket?) knife. Of course, if, in phase 4, the benefits don't match the hope, then the trajectory will, eventually, run in the other direction.
It's good to be a Florida Gator. Much as I wish the outlook at present was rosier, you are spot on.
Spot on, Fireman. If 2-73 is approved doctors will be prescribing it for ALL their AD patients. Moreover, just because it works (if it works) best for a particular segment of people doesn't mean it won't have a positive, albeit lesser, effect on other patients.
Another point I and others have made and it bears repeating: If 2-73 gets ANY indication, it will be prescribed off-label for other diseases. With AD and PDD we're dealing with a desperate patient population for whom present SOC offers little to nothing. Anything that offers the slightest hint of a whisper of hope, especially with a good safety profile, will be taken with urgent enthusiasm by patients and eagerly prescribed by doctors. That's the reason (beyond helping the sick) that an indication for Retts would be so important. Demand will heat up, but AVXL is not equipped presently for manufacture and distribution. Our investment world will become very interesting, very quickly.
Traders than holders.
If 2-73 gets an indication for PDD, neurologists will prescribe it off label for AD. Fact is, if it gets approved for Rhetts, it will also be prescribed for AD. The AD field is essentially wide open; SOC sucks. Desperate patients and their families will plead for any opportunity; and doctors equally desperate to find something that may have, however remote or unproven, a chance to help them, are going to prescribe the drug. In fact, once given any approval the problem will be manufacture and distribution, not demand. If Australia approves for any indication, this same rationale will lead to the EU and US quickly lining up. No amount of FDA circumspection will withstand the political pressure. Mark this: any indication will prove an enormous boon, a kind force multiplier, for AVXL; phase 3 for AD will be sprinted past, and phase 4 will be the decider.
An indication for Rhetts would be significant beyond the obvious hope it entails for patients and their families and the boost to AVXL market cap. If approved, some percentage of doctors will prescribe the drug off label for AD. This would mean a revenue stream, and that's consequential.
Back on the Russell Index!
The FDA just granted Novartis Priority Review for their sickle cell disease drug,crizanlizumab, as a result of data from a phase 2 trial. This shortens the review time from 10 to 6 months. I should mention the drug has additional trials in process; however, my point is, the FDA CAN act expeditiously and w/o phase 3 results. SCD is a a rare disease (comparatively);to be blunt, it sucks and the SOC is miserable. AD is common, it sucks, and the SOC is miserable.
Bourbon, if Aussies and EU approve, it will be politically impossible (as well as garden-variety stupid) not to have fastest track possible approval in US. The need is great and the patients are desperate. The only concern is "if".
A screenwriter!
Thank you. I took it to mean other countries and wondered how I would be unaware.
A sound point. Not one I wish to be true, but nonetheless must be considered. Is it possible that's why the news hasn't been PR'd?
"for the trial which is also being conducted in other international sites"
Other "sites?" Besides Portugal? Am I missing something, or misunderstanding? Can someone please be of help?
All this time I thought it was me.
Yep. Averaged down all the way down the ladder.
Your post must have been in response to someone else's message, because it doesn't make sense in response to mine.
Agree completely. Approval for a single indication will, in my opinion, lead very quickly to off-label prescribing. The neurological diseases 2-73 may help are too terrible and the means of fighting them too lacking in efficacy. Anything that offers hope will be grasped. If approval for Rhetts happens, first quarter income will far exceed what would be normally anticipated.
Dado is talking trash! Now that's not something you see everyday!
Yours is a sound observation. There simply is nothing to support a sharp spike in price. Barring an unforeseen announcement by the company, this will be dead money for some time to come. Still, when it swings low, it's a nice opportunity to add. By the way, are you a U of F grad? I am. Just my 2 bits. (A reference you will understand if you're a Florida grad.)
Hope you are right. I've been in this for more than 3 years and own several thousand shares, but I remain unconvinced that this won't fall once more.
About a year ago I had an email exchange with the reporter who covered this story in whichever newspaper it was. He was not helpful in the least and, indeed, showed little interest. I have no idea what to make of that.
Even a single approval would be significant. Then doctors could prescribe off-label...That would make for an enhanced revenue stream and an informal real-world trial for other indications. Am I wrong in this?
I added at 4 points, all of them well under 2.