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Thank you, Xena. Many of us here value your insights and contributions.
Taken from the AAIC site... Appears I was a little off on my recollection, regarding the last paragraph.
Note: AAIC 2016 Developing Topic abstracts will be considered for poster presentation only unless the research is considered to be late-breaking.
Criteria:
* Late-breaking research/newness of information.
* Potential impact on the research community.
* Quality of scientific research.
* Relevance to Alzheimer's disease and related disorders.
* Topics of interest include basic and translational science, diagnosis and prognosis, therapeutics, and public health and psychosocial issues.
Additional information:
* Previously submitted/reviewed abstracts will not be considered.
* A limited number of abstracts are selected, with selection based on timeliness and scientific merit.
* Only under extraordinary circumstances will abstracts without results be considered.
* Accepted abstracts are published in an online supplement to the * Association's journal, Alzheimer's & Dementia: The Journal of the Alzheimer's Association.
* Developing Topic abstracts must be submitted via the online system.
* Developing Topic abstracts are not accepted for the Alzheimer's Imaging Consortium or Technology and Dementia.
* Developing Topic abstracts do not include the AAIC Featured Research Session format.
* An individual may be the presenting author on one oral presentation (includes a featured research session) and two posters slotted on different days. Exception: An author may present in two oral platforms as long as one is a Developing Topic session.
Also, I thought I read on the AAIC site where a sponsor (company) could not have an oral presentation on the same day and same topic as its poster(s); therefore, to qualify for an oral would require a separate day and topic...which they don't have.
That's a good question. It would seem the dose-response data might be from an earlier time, since that poster was submitted well before the late-breaking poster...unless they updated the information. TBD.
I take it that the Sunday poster will be on dose response and the Wednesday poster will be the 31-wk data, including PK/PD.
Still could happen...
I believe they are two separate items. LPC is the $50M option. Anavex had previously filed to allow issuance for up to 100M shares, if they choose, without additional voting.
Does the market believe Anavex doesn't have things figured out; that they don't have a strategy and aren't working their plan? If you wait for the news, then you've missed out on a fortune.
In the past, "they" manipulated the price to make the $5 options expire worthless; let's see if they try the same thing with the $7.50 options this week. I'm hoping that demand will prevent this from happening.
If Anavex doesn't partner with a know BP, it would be because Anavex has chosen a different path, not that they can't find a partner.
If they are planning to maintain independence, then all financial options are open: grant, LPC, secondary offering and/or partner with a mfr/disto company (not BP). I believe the strategy is in place and the plan is being worked.
Just because WE haven't heard of the "plans", doesn't mean they don't exist. I'm confident in Dr. M and staff, Clayton Parker and the SAB to already have their ducks in a row.
I'm not an expert, BUT donepezil was only 6 months into P3 when it was approved. If 2-73 shows to be more effective than donepezil, likely with restorative properties, then approval could come much quicker. Also, there's the possibility that a Rett's trial could yield approval sooner. That's why I believe, if the drug is that good, then approval will be no later than next June.
IF they decide to maintain independence and retain more control, they would still need to partner with a "generic" type drug mfr, which has established distribution channels (not necessarily a name-brand BP like PFE, etc). Perhaps that mfr could provide trial funds. There's also the probability of gov grants. So dilution is not necessarily a given, at least not in the near term.
The intermediate goal to becoming a BP would be to partner with a mfr/distributor drug company...and not BP itself. That, I believe, is the next step. With Dr. M's new 3-yr contract, buyout is off the table and "BP" partnership seems less likely now.
I guess my recall is not so good...I sure could use some 2-73.
It wasn't "every day"; he bought 1000 shares, each, in several consecutive months. Nonetheless, it was a good signal. I think he believes shareholders and those following closely already know what's coming from the info and actions that have transpired over the past several months.
It's called an 8-k.
I received it as an email. Look on EDGAR.
I think many of us were unfamiliar with the "nefarious cartel" and could not believe that a promising biotech could be attacked so brazenly, under the nose of the SEC. Yes, we all can play woulda-coulda-shoulda, but it doesn't change a thing. What we came away with is an education.
I took the opportunity at $3.72 to add more and convert all of my IRA shares to Roth, taking advantage of the manipulation. So, I turned a negative into a positive: the conversion/income tax I'll have to pay next April will pale in comparison to my tax-free gains in the future.
What makes you think it will play out the same this time, as last Nov? That would be too obvious. No, it plays out differently this time: too much data, too much awareness and too low of PPS and MC. No, this time will be much different...that's the lesson.
Just received the below filing...
Must be expecting the cash to roll in to offer $2M in options for this year and the subsequent two years.
Dr. Missling
), in his continuing capacity as Chief Executive Officer of the Company. The Amendment amends the Employment Agreement by and between the Company and Dr. Missling, effective July 5, 2013 (the
Employment Agreement
), and extends the term of Dr. Misslings employment with the Company through July 5, 2019, unless earlier terminated as provided in the Amendment. Pursuant to the terms of the Amendment, Dr. Missling shall receive an annual salary of $500,000 and is eligible to earn an annual cash bonus for each whole or partial calendar year of up to $100,000. Subject to the terms of the Amendment, Dr. Missling will also receive Two Million Dollars ($2,000,000) of options for shares of the Companys common stock on each of July 5, 2016, July 5, 2017 and July 5, 2018. For the options granted on July 5, 2016, one-third shall vest on each of July 5, 2017, July 5, 2018 and July 5, 2019. With respect to the options granted on July 5, 2017, one-half shall vest on July 5, 2018 and the other half shall vest on July 5, 2019. All options granted on July 5, 2018 shall vest on July 5, 2019.
Such options shall have an exercise price equal to the closing price of the Companys common stock on each grant date.
The summary of the Amendment provided herein is qualified in its entirety by the terms of such agreement, which are fully set forth and attached hereto as Exhibit 10.1 and which are incorporated by reference herein.
I'm waiting for the PR that announces their late-breaking oral podium presentation on July 27th at AAIC. :)
It's simply the graph on the opening AVXL page of iHub.
Nice sound... thanks!
My thinking is that, if there's not going to be the possibility of an oral presentation, then Anavex would have already issued a PR announcing its AAIC participation with poster presentation titles (last year's PR was issued June 30th). Therefore, because they haven't yet released a PR, it makes me believe they are about to release a PR announcing, instead, their late-breaking oral presentation. We shall see...
I, too, believe this to be a good strategy. I did the Roth conversion earlier this year, at $3.72/sh. The nice thing about this strategy is if the investment doesn't work out as expected, one can re-characterize it back to Traditional (by April 15) and avoid paying the taxes.
orveko, excellent compilation of information...
Greatly appreciated!
Thanks for the reminder!
I like the fact that he was once with Tekada.
Read the claims section... melanoma.
Surely you didn't take me seriously.
Or perhaps some powerful placebo effects! :)
Got it... thanks!
Thanks, George, for straightening me out. :)
75% of P2a trial patients were taking donepezil and 25% were not. That's how the company determined that the combo drug might not be additively beneficial than 2-73 alone.
It's anticipated that the P3 trial will be double-blinded: 2-73 vs. donepezil (not placebo, since the FDA already has reams of placebo data from previous trials).
It would seem the only benefit of obtaining a PLUS Patent would be for defensive purposes: not allow the competition to get it. According to the company's recent findings, the combo drug is not additively beneficial for Alz patients.
For ODD, a company gets 7 years of exclusivity; however, I don't know if it's just for that indication or for any use.
I think it somewhat depends on whether Anavex gets a "late-breaking" oral presentation. If so, then likely the writing is on the wall.