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There might be earlier improvement by using a small amount of DZP to help with the initial clearing of plaque (i.e. short term), while 2-73 addresses homeostasis (long term).
We plan on it!
Well said and simply stated...
Nice retort, Xena. Hopefully, that will shub him up!
Can't be "stuck" if we're just getting there. Repeated upward runs with a higher building base bodes well toward punching through...
If something additional was mentioned, then I would expect a PR soon.
Correct... that's what I got.
I got to the webcast site for Anavex, but it says it will be available 24 hrs from the live presentation. We're SOL for now...
I believe keeping the specifics of their data confidential, hidden from the competition, is more of a priority than enlightening their shareholders and the market.
If it's true that the combo therapy, with a specific lower dosage of donepezil, provides optimal results, then it might be that it's related to the initial plaque cleansing attributes of donepezil, but at a dosage that doesn't overly compete with 2-73 for the Sigma-1 receptor.
I agree; Matt's PR firm is not very impressive!
Only a fool would use stop-loss orders on a volatile stock such as AVXL. If one felt compelled, they should only be used immediately after a large jump in the share price. With the potential this company has going for it, one should just hold long term.
Interesting scenario, but don't you think we'll have Alz P3 underway well before 2-73 is approved for Rett's? Early results of Alz P3 should show consistent efficacy with, both, previous Alz P2a results and Rett's P2.
Question remains: who is the partner that manufactures, markets and distributes the drug for Rett's?
Yes, I'm certainly glad to see the institutions which are participating to date. My point is that institution participation will increase substantially with a confirmed P3 announcement. Then we can permanently say goodbye to the $4s, $5s and perhaps the $6s.
I think it's a foregone conclusion that we'll see substantial tute investment once P3 is announced. I've heard a few fund managers, over the years, make that very statement in financial news interviews.
Most institutions have guidelines of not investing in a startup biotech until its drug is, at least, into Phase 3.
Partnership prospects are completely different.
It's hard to imagine that any substantial biotech investor or investment firm would not already know about Anavex.
The "minimum of $600k" may have to do with the number of patients they end up enrolling. Perhaps $600k is for 50 patients and more funds if 80 patients.
Well stated. Once P2/3 is announced then institutions will begin stepping up in earnest.
Below is a link to Takeda's most recent deal... with Ovid.
Excerpt from the article...
“Ovid’s agility, exclusive focus on developing therapies for rare neurological diseases and specialized capabilities in central nervous system drug development are highly differentiated and well suited to this important program,” said Emiliangelo Ratti, head of the central nervous system therapeutic area for Takeda.
Might this detract from a potential deal with AVXL? Perhaps BIIB has an exclusive deal locked down?
Takeda and NY biotech Ovid ink rare drug development pact
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That's something. I didn't get a response to my VA email.
You have a point, but I believe Anavex is working with the FDA on these trials. We'll see if there is a second P3 trial being arranged in the US.
In my opinion, I think it's a done deal with either a partnership or BO with BIIB. Though, I'm leaning toward Partnership, just because of small dilution that was recently done for a little extra cash and time. We'll see...
Very nice! I especially like the following excerpt...
"We intend to be among the first to deliver a disease-modifying therapy for Alzheimer’s and to do the same for Parkinson’s disease, ALS, and neuropathic pain. Success in these pursuits will transform the lives of millions of patients around the world.
And we will continue to pursue and build strong strategic partnerships and external collaborations as we continue to go after new opportunities and expand our pipeline."
Where have I heard that before? :)
When the time comes, announcing a relatively small 300-patient P3 trial should speak volumes to institutions and other knowledgeable biotech investors... that the FDA has confidence in the outcome!
Perhaps they can't say anything until the FDA has given approval for the trial (design, etc.).
Exactly. If $5B is a BO price, then perhaps Avavex's value, given the amazing data and testimonials, should be $2B now. No doubt the price is being held down, but there's also insufficient awareness...and the fact that P3 hasn't yet begun. Once P3 is announced, then many more institutions will be buying in.
That tells you just how undervalued Anavex is currently.
I'm in your camp... holding large and long. Catalysts will be announced in the near term.
First time in my life I wish that time would speed up!
I see it as more runway for a deal to get done. Perhaps after Biogen's spin-off? Dr M says that $17M supports them for 2 years. To me, that's only true if they have either a partnership or grant(s) in the works to fund P2/3.
Yes, I saw that. It just seems curious to me that he starts in his new role the Friday before the investors conference on Monday. Might be some interesting announcements made?
I would hope the new CEO will want to have something very positive to say during next week's investor conference.
The game will change once in Phase 3. I've heard it said before by a large institutional investor on CNBC that they don't invest in biotech until the drug is in Phase 3. Too risky otherwise.
The FB group represents more than 2M shares that the short cabal will never get its hands on in hopes to cover. That's about as profound as it gets!
It was my belief, after AAIC, when the trial readouts were changed from week 38(43) to week 36(41), was when some or all of the patients were moved from dual therapy to mono. Why else would they make the readout change? It would seem to correspond with the timing of AAIC results that indicated the superior data of the monotherapy patients. I messaged IR at the time, but did not receive a reply.
It seems doubtful that patients could improve so quickly if they were changed only after week 48(53) or 52(57).
Yeah, Google is amazing.
The P300 (P3) wave is an event related potential (ERP) component elicited in the process of decision making. It is considered to be an endogenous potential, as its occurrence links not to the physical attributes of a stimulus, but to a person's reaction to it. More specifically, the P300 is thought to reflect processes involved in stimulus evaluation or categorization. It is usually elicited using the oddball paradigm, in which low-probability target items are mixed with high-probability non-target (or "standard") items.
When recorded by electroencephalography (EEG), it surfaces as a positive deflection in voltage with a latency (delay between stimulus and response) of roughly 250 to 500 ms.[2] The signal is typically measured most strongly by the electrodes covering the parietal lobe. The presence, magnitude, topography and timing of this signal are often used as metrics of cognitive function in decision making processes. While the neural substrates of this ERP component still remain hazy, the reproducibility and ubiquity of this signal makes it a common choice for psychological tests in both the clinic and laboratory.
DT is a scam operation... just look at the hack disclaimer.
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Well put. When common sense, logic and probability are applied, it's simply irrefutable.