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I received this clarification email today:
Hello -
In response to your question below, on the assumption that we secure approval for our monkeypox virus test as an LDT from the New York State Department of Health (NYSDOH), our sales strategy is for our clinical lab subsidiary to serve as a reference lab to hospital systems and larger clinical labs in New York State, as well as clinical labs located in other States that allow sample processing by clinical labs permitted under the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP), currently approximately 46 states nationwide. Any samples collected from NYS or another state under CLEP-permittance can only be processed in our clinical lab in N.Y.
We have experience in this model this year as we served as a reference lab for COVID-19 testing, for which we utilize an internally-developed diagnostic test conditionally approved as an LDT by NYSDOH. If approved, our monkeypox test would follow the same path to market.
Given this, we have no current plans to seek FDA approval for this diagnostic. To be precise, we are not a diagnostics manufacturer. Rather, we are a testing services provider that has developed a PCR-based test that requires a workflow that is unique to our clinical lab and leverages the established workflow for our COVID-19 testing service. This then makes the LDT regulatory path the optimal one for us.
We offered a deeper discussion into this diagnostic's path to market on our quarterly investor call last week, which you can access here: https://investors.adnas.com/news-events/company-events/
What I’n thinking about is licensing the test out to a company like Labcorp, so anyone anywhere can walk in and get tested.
Is there any move underway, once approved, to get this test out beyond NYC to the rest of the country?
Probably just safety. Efficacy seems a long way off.
Curious why that news/ buzz would create an eod bump in ADNA when it cane out early in the day.
What happened eod?
Re my own question:
On-going Open-label Study with Simufilam in Alzheimer's Disease
In March 2020, we initiated a long-term, open-label study to evaluate simufilam in patients with mild-to-moderate Alzheimer’s disease. The study is intended to monitor the long-term safety and tolerability of simufilam 100 mg twice daily over 12 months or more. This study has reached its target enrollment of approximately 200 patients. We expect all patients for this study will complete drug treatment in Q4 2022. We expect to announce top-line clinical results for this study approximately year-end 2022.
When is SAVA due to report further study results?
A true Bodhisattva vow. Are you truly willing to hang around that many lifetimes?
LaJolla, I thought you had retired to the Cove to work on your tan. What made you reprise your missionary role?
3rd world vehicle, IMO.
Great interview.
I know. I like it.
Currently 12.9 million shares outstanding.
I think highly likely to spread to the general population. There are lots of bi’s out there who will spread it to both genders. Parents will inadvertently give it to their kids. Day care workers give it to care receivers. Couples to each other. No reliable quick test exists now. No where enough vaccine is available. As soon as a reliable test exists, the govt will start offering offering it for free. All the established test sites will need to offer it. Anyone with so much as a pimple on his/her butt will want to be tested. JMO.
Would you ever foresee Alkon’s private dx company being bought out by SNPX?
In your opinion does this also validate to a further extent the MOA of bryostatin?
Is there a December scientific meeting thar results might be announced at?
If the current AD trial produces excellent results is there any chance that an EUA for AD might be requested?
Sounds like a very expensive P3. Glad they have the coin to pull it off.
Thanks. Would love to see a sale with this low ss.
3K shares traded??? Someone is paying up for a few shares. What is the OS / float share count at this time?
Runn, have you seen this new method of AZ DX? Sounds like a fairly economical way to diagnose the disease.
https://scitechdaily.com/single-brain-scan-can-diagnose-alzheimers-disease-quickly-and-accurately/
How big is the market for treatment of UCD's?
I'm unclear re your purpose here. You have posted thousands of words, mostly negative. Are you short the stock? Are you trying to save uninformed investors from making a bad investment? Are you enjoying poking fun at people who have realized or unrealized losses here? Do you have a vendetta against the company? Are you showing off your skill reading of SEC docs? Please enlighten us who are not as far along on the Bodhisattva path, so that we too might join you under the bodhi tree.
Just wondering if there is a financial incentive somewhere.
What is behind Lame Simian's writing all the SA hit pieces on Cassava? Just curious.
Thanks. So more $$ into the coffers.
Thanks. I only have a toe in the water here.
Can someone explain this new Form 4?
Thanks. Sorry I asked.
What’s happening here??
This latest slaughter of children should convince somebody that non- radiation detectors are essential. Such a sad day.
Reservatrol has been proven to be worthless.
https://nutritionfacts.org/2022/01/18/the-best-source-of-resveratrol/
Coach, does the Harvard paper in your opinion support the SNPX MOA?
Coach, did I miss any comments by you re Lane Simonian's recent piece in SA?
Summary
Efforts to manipulate growth factors including those being undertaken by Athira and Synaptogenix are unlikely to be successful because the pathway through which growth factors work is inhibited by nitration.
Anti-amyloid treatments such as those being undertaken by Biogen and Eisai, Eli Lilly, and Alzheon appear to only modestly slow down the progression of the disease in APOE4 carriers.
Aricept and Cassava Sciences' simufilam may accelerate the decomposition of the nitro-oxidant peroxynitrite, which may partially explain why they lead to improvements in cognition that are maintained for a while.
Drugs and natural products that scavenge peroxynitrite, including Anavex's blarcamesine, Cyclo Therapeutics Trappsol Cyclo, and panax ginseng may lead to improvements in cognition that are sustained for a long time.
Have been in SoCal for past 2 weeks, San Clemente. The whole area is awash with $$$. You don't see kids on bicycles anymore; they all own E-bikes. I think the market for these $1200+ bikes would be huge in the rest of the country.
Was this posted?
Dallas, Texas, April 19, 2022 (GLOBE NEWSWIRE) -- Alternet Systems, Inc (OTC Pink: ALYI) will publish a detailed shareholder update highlighting the company’s latest developments. The update will come out tomorrow, Wednesday, April 20, 2022.
ALYI recently published its 2021 annual report which included a confirmation of ALYI receiving a $2 million purchase order for electric motorcycles for which a deposit was received, and a first shipment sent before the end of 2021.
From the published ALYI 2021 Annual Report:
“On September 1, 2021, the Company received a $2,000,000 purchase order/agreement for 2,000 electric motorcycles FOB Nairobi, Kenya. These motorcycles are to be delivered over the term of one year in allotments agreed to by both parties. This agreement called for the buyer to advance the first $200,000, which was done. The first allotment was shipped from China in December 2021.”
ALYI is building an EV Ecosystem that includes organic and partner solutions for all aspects of the growing EV transportation system.
The update tomorrow will detail how ALYI is building on the 2021 $2 million revenue contract to ramp up revenue in 2022.
We were the lead study center for Eliquis, although I was in clinical at the time, not research.
Lol! Likely true.