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Here's what was included in the PR when they announced the location would be Australia, although it doesn't specifically say why.
“After a thorough review process including many international sites, we are very excited to be working with The Alfred Hospital, a world-renowned institution with significant experience in conducting Alzheimer’s clinical trials,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex."
Thanks LJ! And there's one catalyst that nobody can predict when it will happen - with everything that we're seeing in the news everyday about this disease, it's just a matter of time (hours, days, weeks) before the main-stream press writes an article or does a segment on the evening news about the promising results that we're seeing with Anavex. It will give AVXL a tremendous amount of exposure and excitement that not even the shorts will be able to contain or refute.
You may want to add the Bill & Melinda Gates Foundation.
From Wiki:
The request can be initiated at any time during the drug development process. FDA will review the request and attempt to make a decision within sixty days.
Fast track designation is designed to aid in the development and expedite the review of drugs which show promise in treating a serious or life-threatening disease and address an unmet medical need.
Serious Condition: Determining whether a disease is serious is a matter of judgment, but generally is based on whether the drug will have an impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress from a less severe condition to a more serious one.
Unmet Medical Need: For a drug to address an unmet medical need, the drug must be developed as a treatment or preventative measure for a disease that does not have a current therapy. The type of information necessary to demonstrate unmet medical need varies with the stage of drug development: early in development, nonclinical data, mechanistic rationale, or pharmacologic data will suffice; later in development, clinical data should be utilized. If there are existing therapies, a fast track eligible drug must show some advantage over available treatment, such as:
* Showing superior effectiveness
* Avoiding serious side effects of an available treatment
* Improving the diagnosis of a serious disease where early diagnosis results in an improved outcome
* Decreasing a clinically significant toxicity of an available treatment
* Addressing an expected public health need
What are you basing this on - this is not GILD. They plan to start P2b/P3 within the next 12 months, and it's not going to take 4 years to complete. Most people believe that if successful, it can be on the market within 2-3 years or sooner given this is for AD, and especially if they get FDA Fast Track designation which I think they have a good chance of getting.
Can one of the moderators sticky this at the top under DD?
Thanks
I know many of the longs here believe that you can prevent anyone from borrowing your shares for shorting if you put your shares up for sale with a very high $ amount (so that it won't get filled). If you haven't heard by now, that does NOT prevent them from being loaned to shorts. Most brokers (not all) will loan your shares for shorting if you keep them in a "margin" account, as opposed to a "cash" account. I got so fed up with the shorting this week that I just called etrade and told them I wanted to make my shares unavailable to shorts and to register my shares in my name. They told me the only way to do it was to change my primary account (which is marginable) to a cash account, however there are benefits to having a margin account that I didn't want to lose. Instead of changing my primary account to a cash account, I told them to create an additional account (cash) and link it to my primary (marginable) account so that I can easily move my AVXL shares from the marginable account to the cash account. It's very easy and you can do it all online. It took me about 5 minutes. If you want to prevent shorts from borrowing your shares and using them against you, and you want to keep your marginable account, I would suggest you do the same thing - create an additional "cash" account and use it for storing your shares until you're ready to trade them.
Thanks Xena - I really appreciate your posts. Very informative and factual!
Up to $5.23 from a low of $3.60 - bummer.
Yes, and I suspect Dr. Missling's doing a lot of things behind the scenes right now to keep this moving forward.
Although it's not exciting, today's action is much less volatile (less than 1m shares traded in the 1st hour when it was previously ~5m). I suspect many, not all, of the shorts have moved on to other targets. Yesterday's and today's action is healthy for the share price - constant churning in the channel and building a consolidated base before the next step up.
Thanks Circa - that clears things up!
I absolutely AGREE! With everyone focusing on the negative this week, the potential for this company is still enormous! There's "NO" debt and they have "PLENTY" of funds to carry them well through next year - they're not dependent on the share price. And can you imagine what's going to happen to the pps if/when they announce a partnership with BP to fund P2b/P3? That can happen at ANY time given the current results! And let's not forget the 12-week update that we'll be getting soon.
Any more thought about the P2b trial? We all know the P3 is required but the P2b trial remains to be a grey area on this board. Can't help but wonder if it will still be required given the positive results that we continue to see on P2a. And given the disease, I assume Anavex will at some point submit a request for the FDA Fast-Track designation to speed up the review and approval process. Your thoughts? TIA
Tom - I can't say if you're right or wrong because I honestly don't know. The one thing that I've learned over the past week is to not underestimate those who've been manipulating the pps and driving this down by using NSS, triggering stop-losses and margin calls. I "suspect", and I could be wrong, that the shorts have run out of steam and not shares to borrow because this short attack has been going on since last Wed. And due to the 3-day rule, they would have already covered for last Wed-Fri. I think, and again I may be wrong, that many of those who were shorting by using NSS have moved on to other targets after driving the price down 75%. I think what we saw today were some of the smaller retail shorts and profit taking by those who bought in the $3-$4 range yesterday. Therefore I'm expecting a slow day-to-day increase with daily consolidation - just like today. Let's hope those who are taking advantage of these low prices are now buying more shares without margin!
What makes you think they're "waiting"? They've been shorting this all day. If that was their current plan, they'd just step back and let it rise now - why wait?
LOL - that's got to be the #1 post for today!
Yeah, but if you noticed, it was up until a few minutes ago. From what I've seen, AH trading is pretty much meaningless due to the low volume and can easily be managed by the shorts, although they seemed to be struggling with it for the first hour or so after the close. They didn't succeed at the closing bell, so now they're putting on a show for what it's worth. I guess it's a few stragglers that didn't get the memo.
And not to mention over 16 of the 20 million shares were traded today. Sure, there's no NSS involved here. LOL
Sometimes it's just not worth the effort to respond to frrol - you can never convince a shorty to admit the truth.
canderson - why don't you ask frrol (our resident shorty) to do the same - show how NSS WASN'T used to short this down?
With all of the savvy people on this board, I wonder if there's a way to post it so that it pops up when someone Google's his name?
I may be wrong but I don't think he can ask the numerous exchanges to not allow naked shorting on AVXL in Germany, however I believe he can request they remove AVXL from their exchanges which has the same net effect.
Oh, I see - if it's shorted from $14 down to $4 by people like yourself, then it's doomed, regardless of the science. Perhaps you should go back to asking "do you want fries with that?"
I wouldn't expect him to address the NSS in Germany unless he has specific proof they were involved, even though I think we all know they're probably one of many who were in on the short attack. Way too many trades over the last two days to not have included NSS.
No, they're still here. Not sure if you noticed but they bring on their strongest attack from 3:50-4:00 every day, and today was no different. The price almost hit $6 but they managed to push it back down to the $5.30 range in the last 10 minutes of trading. The good news is it looks like they're running out of steam - the bulls pushed it back up to the $5.40 range. I think we're starting to see a reversal, but I don't expect the shorts to give up easily. If they were gone, this would have easily broke well past $6 this afternoon.
Quote from Macfarlane in new SA article just out:
All very good points! Thanks for bringing some sanity to this board!
Sal - I've been holding back on responding to your ridiculous comments simply because I felt sorry for you due to how much you lost on ONCS, and some of the other self-promoting and silly pumping posts that you've made. If I need or want your advice, which I would never take due to your laughable and disasterous track record, I can find you anytime. All I need to do is wait 30 seconds after the next JBEM pick telling everyone what a fantastic pick and how you had been watching it, too. The funny thing is that everyone knows you're nothing more than sour grapes when it comes to this stock - you would still be in the $s if you hadn't sold so prematurely before the RS.
BTW- JBEM's track record is extremely good and it stands on it's own. You really don't need to pump his choices - it only scares people off.
I can't help but laugh when I hear people accusing LP of selling shares. In case you haven't noticed, the pps has DECREASED each of the last four days. Why would LP buy their shares at a MUCH HIGHER price and then "dump" them at a MUCH LOWER price? That's not how successful businesses operate. And if you read the agreement between Anavex and LP, it limits how Lincoln can purchase and sell the stocks. Everyone's looking for a villain to blame. You don't have to look far - start with AF and others who stand to gain from the drop in price.