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This is from another board. It’s an interesting read imho.
For those who bemoan Dr. M’s leadership, reading this article should make you grateful that he has chosen LPC thus far instead of secondaries at a discount to market.
That being said one should also probably realize just how influential LPC can be to daily price fluctuations.
“It is very likely that this short seller covered with the offering shares. It’s like an upside down pump and dump; almost guaranteed money if you know what you are doing, or even better, are privy to inside information concerning when the offering will be announced.
You artificially inflate the price with frivolous or even outright fake PR, pump it up by placing bids to attract speculators, then you artificially change the price by offering the shares in bulk 50% lower than the current price. How can you lose?
https://stocktrades.exchange/2019/09/27/hmny/
“My greatest hope and what I am excited about in her future are intricately linked. Trofinetide is my greatest hope. *disclaimer: her trial has not been unblinded, this is my personal opinion* I’ve seen it at work. My daughter has felt it at work. Katelin has only love and admiration for Trofinetide and the people who work on it; it’s obvious every single time we do something like this, meet people involved in the trials, when we met Margaret, when we meet James Shaw and Dr. Nancy Jones of Neuren. She KNOWS it works and she’s waiting very patiently for it. Sometimes when she’s very upset, I tell her…when Trofinetide comes, this will be alright… and she calms right down.”
“Well, of course, I said the Trofinetide Phase III excites me, lol. But, there are other developments as well. Anavex 2-73 is an exciting possibility. One area that is intriguing is the use of stem cells and one recent practice is feeding a fresh placenta to children, you can find out more about it here- Placenta Preservation. But, what excites me the most is the sheer number of trials in some stage of development or another.”
https://trailtoatexastrial.wordpress.com/
https://www.sec.gov/cgi-bin/browse-edgar?CIK=Avxl&owner=exclude&action=getcompany
I don’t see them. How about including your link?
Oh look, the low occurred around 200 k volume. Time for LPC to buyback those commitment shares?
Wanna give it a try? I would love to see what the conversation looks like. I don’t want to risk getting it wrong.
https://www.westernu.edu/mediafiles/research/iacuc/dose_conversion_between_animals_and_human_%20JBCP_2016.pdf
I believe, company submits, publication decides on worthiness of publishing the submission. It was revised around the same time as this...
https://rettsyndromenews.com/2019/09/19/preliminary-trial-data-anavex-2-73-rett-syndrome-suggest-safety-efficacy/
From April to September it apparently waited in the publishing que.
Actual Study Start Date :
February 28, 2019
21 participants: 6 PK open-label followed by 15 double-blind, randomized, placebo-controlled
This is a 7-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of patients with RTT 18 years
Received 23 May 2019
Received 23 May 2019, Revised 26 September 2019, Accepted 4 October 2019, Available online 5 November 2019.
https://www.sciencedirect.com/science/article/pii/S0091305719302515#!
Behind a paywall but if anyone has access, it would be very interesting to see the dosing used for comparison to doses administered in humans.
Probably not because I already gave an example of blinded trials revealing the doses.
But this is even more hilarious...
http://gomerpedia.org/wiki/Quadruple-Blind
“... blinding of participants, investigators, assessors, and data analysts. “
Which one does not revealing the dose fall under?
“Thus quadruple blinding must mean that the allocation schedule has been lost and nobody knows anything.”
Lol. That made me laugh!
https://www.slideshare.net/mobile/TarekTawfikAmin/blinding-in-clinical-trials
Thanks for the constructive reply.
No. You said you gave reasons it supported their MOA/efficacy thesis. I just wondered what those “reasons” were because I don’t read every post.
Very interesting! Thanks for sharing.
“By June, as Biogen analyzed the full data set, researchers started to realize that a different picture was emerging of aducanumab, Sandrock said. The reason was because of changes that Biogen had made to the study late in the game. Initially, the company worried about a potential side effect — brain swelling — and limited the dosage of the drug. But later patients were allowed to receive higher doses of the medicine.
“In retrospect, the results of the futility analysis was incorrect,” Sandrock said. “That’s because it was from a smaller dataset that looked at patients with less exposure to high dose aducanumab.”
In essence, Sandrock said, the futility analysis had happened too soon. It had looked at data based on last December. But the trials were actually stopped in March. Biogen had run two studies. One, was positive in its own right for the high dose. A second still failed, but shows signs of benefit in those patients who received the higher dose of aducanumab.”
https://www.statnews.com/2019/10/22/biogen-to-submit-aducanumab/
Well no. But the stock price would still be much higher.
Perhaps instead of completing the blinded trials and disclosing the results, Neurotrope should have delayed the results by expanding their trial to another country and offering an unblinded extension to all participants?
https://apple.news/AwCr-T48GRAqGgVb-Edyzsg
“GMP analyst Justin Keywood reiterated his buy rating on Aphria stock on the news and said it remains on GMP’s Best Ideas list”
Press Releases
Arch Therapeutics Announces $2.5 Million Registered Direct Offering
Download PDF
FRAMINGHAM, Mass., Oct. 17, 2019 (GLOBE NEWSWIRE) -- Arch Therapeutics, Inc. (OTCQB: ARTH) ("Arch" or the "Company"), developer of novel liquid, gel and solid hemostatic and wound care devices, today announced that it has entered into definitive agreements with several institutional and accredited investors for the purchase in a registered direct offering of 14,285,714 shares of its common stock and warrants to purchase up to 14,285,714 shares of its common stock, at a combined purchase price of $0.175 per share and related warrant. The offering is expected to close on or about October 18, 2019, subject to the satisfaction of customary closing conditions.
H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.
The warrants have an exercise price of $0.22 per share of common stock, will be exercisable immediately upon issuance and will expire five years from the issuance date.
The gross proceeds of the offering are expected to be approximately $2.5 million, before deducting the placement agent’s fees and other estimated offering expenses. Arch currently intends to use the net proceeds from the offering primarily for working capital and general corporate purposes.
The securities described above are being offered by Arch pursuant to a “shelf” registration on Form S-3 (File No. 333-213878) previously filed with the Securities and Exchange Commission (the “SEC”) on September 30, 2016, amended on October 17, 2016 and declared effective by the SEC on October 20, 2016. The offering of the securities will be made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and accompanying base prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the final prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at 646-975-6996 or e-mail at placements@hcwco.com.
https://apple.news/Avj7mAISgRcWVy22QtoVYxA
Haters gonna hate I guess.
“U.S.-listed shares of Canadian cannabis company Aphria Inc. (APHA) (APHA) rose 22% in premarket trade Tuesday, after the company posted a profit for its fiscal first quarter, and not the loss that analysts were expecting”
https://apple.news/A_zWJrvWjS6SBxR80NbRbTw
He did seem to say they licensed it which was something I’ve never heard before. I’ve seen other companies who licensed drugs include the licensing terms in their SEC filings but have not ever noticed it in any of the Anavex filings I’ve looked at.
Seems like something no one here was aware of either apparently.
At ~31 minutes DrM said Anavex licensed 2-73 from a university (couldn’t understand the name). I can’t recall ever seeing that mentioned in their SEC filings. Anyone know the back story. He also said Anavex owns the molecule. Does one really own something if the patent is expired?
http://wsw.com/webcast/cantor10/avxl/index.aspx
Obviously the newly issued crystalline form patent will be added but is there something which would prevent another company from selling 2-73 as long as they don’t manufacture it in the crystalline form? Is there something about the crystalline form that makes it superior to the non crystalline form.
I seem to recall that drug concentration stopped increasing at 60 mg in the phase1 study probably due to the following...
“Gastrointestinal effects were predominantly observed at the highest 60 mg dose. The complaints were abdominal pain (1), nausea (2), vomiting (3), and acute diarrhea (1). “
https://anavex.com/wp-content/uploads/A-Phase-1-Dose-Escalation-Study-to-Investigate-Safety.pdf
I could see that possibly Anavex pursued the Crystalline form as a way of addressing the concerns from the Phase 1 trial by increasing drug concentration at a lower dose that would avoid the intestinal issues.
“However, the major challenge with the design of oral dosage forms lies with their poor bioavailability. The oral bioavailability depends on several factors including aqueous solubility, drug permeability, dissolution rate, first-pass metabolism, presystemic metabolism, and susceptibility to efflux mechanisms. The most frequent causes of low oral bioavailability are attributed to poor solubility and low permeability.
3. Techniques for Solubility Enhancement
Solubility improvement techniques can be categorized in to physical modification, chemical modifications of the drug substance, and other techniques.
Physical Modifications —Particle size reduction like micronization and nanosuspension, modification of the crystal habit like polymorphs, amorphous form and cocrystallization, drug dispersion in carriers like eutectic mixtures, solid dispersions, solid solutions and cryogenic techniques.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3399483/#!po=0.649351
I’m just not sure that higher doses would make any difference though if the sign that patients are approaching their MTD is due to headache and dizziness though because that apparently occurred at <50 mgs which is already below the point where digestive issues became the limiting factor to drug concentration.
“We own one issued U.S. patent entitled “ANAVEX ® 2-73 and certain anticholinesterase inhibitors composition and method for neuroprotection” claims a composition of matter of ANAVEX®2-73 directed to a novel and synergistic neuroprotective compound combined with donepezil and other cholinesterase inhibitors. This patent is expected to expire in June 2034, absent any patent term extension for regulatory delays. A related continuation application is also pending in the U.S. In addition, we own one issued U.S. Patent with claims directed to methods of treating melanoma with a compound related to ANAVEX ® 2-73. This patent is expected to expire in February 2030, absent any patent term extension for regulatory delays.”
https://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=13578194-993-124908&type=sect&TabIndex=2&companyid=660924&ppu=%252fdefault.aspx%253fcik%253d1314052
If you want to understand how LPC operates you first need to read the agreement.
https://yahoo.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=13642818-979-151072&type=sect&TabIndex=2&companyid=660924&ppu=%252fdefault.aspx%253fcik%253d1314052
Purchase of Shares Under the Purchase Agreement
From the date hereof, we may, from time to time until July 1, 2022, in our sole discretion and subject to certain conditions outside of Lincoln Park’s control, direct Lincoln Park to purchase up to 200,000 shares (the “Regular Purchase Share Limit”) of our common stock on any business day ... The purchase price per share for each such Regular Purchase will be equal to the lower of:
? the lowest sale price for our common stock on the purchase date of such shares; or
? the arithmetic average of the three lowest closing sale prices for our common stock during the 10 consecutive business days ending on the business day immediately preceding the purchase date of such shares.
The LPC agreement is not an ATM agreement.
“Liquidity
Other than our rights related to the At-the-Market Offering and the Lincoln Park financing, there can be no assurance that additional financing will be available to us when needed or, if available,”
https://google.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=13578194-993-124908&type=sect&TabIndex=2&companyid=660924&ppu=%252fdefault.aspx%253fcompanyid%253d660924
The Cantor agreement is an ATM the LPC agreement is an ELOC. I’ve described the difference between the two types before.
Now re-read the following post and the likely methodology of LPC might be clear.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=151143968
Try this... Suppose that Monday I give you 200k shares of Anavex for free. Your cost basis is $0. Now suppose that Tuesday , shortly after the market closes you must buy 200k more shares from me. Lucky you though, because your purchase price is the lowest price of Anavex stock that occurs at anytime during Tuesday’s trading. You are not allowed to short. Would you do anything with your free shares to ensure you can sell the 200k you have to purchase Tuesday at a profit Wednesday?
Really?
Well, it could be that seasoned biotech investors are disappointed in the actual details from the presentation slides. Slide 13’s line seems significantly impacted by a single patient’s data to me.
https://www.anavex.com/wp-content/uploads/2019/09/ANAVEX2-73-RS-001-Finland-Conference-Sept-2019-Final.pdf
LPC?
You prefer a cabal of some sort?
“... provided that at least one business day has passed since the most recent purchase.”
Why do you suppose the purchases are required to be one day apart?
“The Company may direct Lincoln Park, at its sole discretion, and subject to certain conditions, to purchase up to 200,000 shares of common stock on any business day, provided that at least one business day has passed since the most recent purchase.”
https://google.brand.edgar-online.com/displayfilinginfo.aspx?FilingID=13578194-993-124908&type=sect&TabIndex=2&companyid=660924&ppu=%252fdefault.aspx%253fcompanyid%253d660924
Volume so far is ~ 230k shares isn’t it?