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Reasons why PD data is delayed
Someone on Stocktwits called Annovis's IR and learned that:
- the Data and Safety Monitring Board (DSMB) was the responsible of the delay
- the IR person said DSMB is pondering whether or not Annovis should continue enrolling more patients for its ph3 PD trial
Two possibilities:
A- Data was horrible and the DSMB thinks it is better to stop here and saving patients' time.
B- Data was so good that the DSMB thinks current patient population is enough to demonstrate statistical significant efficacy, which will expedite the approval process.
Arguments supporting outcome B include:
- Positive and correlated feedback from ph2 PD patients with their being in the treatment arm.
- Noticeable improvement in PD symptoms (Maria mentioned writing speed).
- Enthusiam from the patient community in enrolling into the trial (Maria mentioned some centers had to stop recruiting because they reached their quotas).
On the valuation side:
- Company like Cerevel (CERE) has an enterprise value (EV) of $3.1B.
- CERE essentially has one phase 3 asset in PD and a three others in phase 2.
- Their lead drug candidate is just a better version of levodopa.
A quick and dirty valuation math gives us around $800M of value for this asset (simple division but in reality more as it is more advanced than the rest of the pipeline). Annovis's EV is only around $150M. If (when?) market recognizes buntanetap's potential, share price may reach $100+... on PD alone. Because if improvement is shown in PD, it is a confirmation of Maria's hypothesis for AD as well.
Thank you for those who took the time to read this and good luck.
https://finance.yahoo.com/news/annovis-bio-submits-international-patent-123000706.html
This patent application would have passed as a benign piece of news but for those who have done their scientific research and understood Dr Maccecchini's hypothesis, this is potentially big.
This further confirms the hypothesis that neurons die in similar fashion in most of the neurodegenerative diseases and brain injuries: AD, PD, post-stroke, Niemann-Pick type C, ALS, SMA, Stargadt disease etc
Injured neurons present abnormally large endosomes and axonal transport and synaptic transmissions are impaired... all of which Buntanetap managed to reverse.
Please download my two research slide decks on Annovis's underlying science and how Buntanetap may be the Penicillin of neurodegenerative diseases (warning: scientific DD inside):
Report #1: https://drive.google.com/file/d/1Nt4BJURr0psZ6QkM7UX77TCZI1IJdNSJ/view
Report #2: https://drive.google.com/file/d/1ojb1BbftmDH6VKLRA8GM6gCeB4ulLoLp/view?usp=sharing
She needs to appear respectable in her line of work. Since she seems to have lasted quite long in that career, I believe she weighted the pros and cons carefully before writing her positive piece on NWBO.
You know, the usual "be wary of the old players in a game where people die young".
Annovis Bio's new entry on ClinicalTrials.gov for Phase 3 Parkinson's Disease: https://clinicaltrials.gov/ct2/show/NCT05357989?term=annovis&draw=2&rank=2
Study start: June 2022
Primary completion: January 2023
Study completion: March 2023
(all estimated dates)
Company is at less than $82M market cap with around $20M in cash and one proven phase 3 asset in PD with promising interim results... This is insanely undervalued!!!
DUE DILIGENCE on Annovis in the document below:
https://drive.google.com/file/u/1/d/1OIWmQENqhj0_ibWuHp7QOJN2lO1RjOW6/view
The Company now has TWO phase 3 assets for AD and PD with an MOA that is potentially best in class (not relying on artificially boosting neurotransmitters or stimulating/antagonizing neuronal receptors of dying neurons). Buntanetap actually HEALS neurons.
I made a slide summarizing everything I learn about Annovis and its drug-candidate. Please share the slide deck so more people know about the comapany.
https://drive.google.com/file/u/1/d/1OIWmQENqhj0_ibWuHp7QOJN2lO1RjOW6/view
No fund flow into the stock recently.
Market is waiting for additional data or confirmation of well-known players about Posiphen because on its own, it only understands p-values.
I just checked the still on-goind AD trial:
NCT02925650
24 patients
60mg/120mg/180mg/placebo
I remember in recent weeks, we have seen some PR operations which I don't know if they were initiated by BioCryst:
- They won a prize for R&D
- They won a prize for marketing
- Barron's did a favorable mention of the Company
Looks like the big boys are shifting the narrative.
I got a reply from Maria about what she thinks of the dosage response in terms of efficacy.
She pointed out this is what was seen in animal models for AD and PD.
For PD mouse model: positive response was seen at 3mg/kg, optimal dose was 10mg and the mice did worse at 25mg/kg.
For AD mouse model: positive response was seen at 10mg/kg, optimal dose was 25mg/kg and mice did worse at 50mg/kg.
On the biomarker and dosage, she said some of them was down to 50% at almost toxic dose of Posiphen (based on previous human trials, I assume the dosage is around 180mg/kg). So far, we are seeing 5% to 20% in optimal doses (Maria mentioned she is considering 10mg to 30mg for future trials), we are actually no that far off in terms of dose dependent response for biomarkers. Maria said that for PD, a 5% decrease in alpha-synucleins is "absolutely adequate". When you think about Posiphen's MOA, it is sensible as you don't want to inhibit APP 100% since this protein precursor is still needed.
My take on all the data we have so far:
- It is not incommon for drugs to demonstrate a non-linear relationship and that's why you have phase 2 trials.
- All the results on humans are consistent with animal models so far.
- Given the short duration of the trial, we have seen consistent improvement in anything related to short-term and working memory, which is what deteriorates first at the onset of the disease (We have seen improvement in WAIS coding test, ADAS-cog3, 6 &11).
- The design of the trial just did what Maria intended to do: determining the optimal dosage to demonstrate efficacy.
No, phase2b 40 PD patient trial.
I think it is a public show of the poison pill clause. There may have been a potential buyer who wanted to play hard ball but got cock-blocked by Jon "Biochad" Stonehouse.
These are not rumors as I asked GBOX's IR about it. Here is the email:
Thanks for reaching out and the support. All good questions about the token launch. We haven't announced securing seed capital yet. The company is exploring several ways to fund the revolver including debt, equity, SPAC and self-funding to start. Equity is not likely currently due to the share price valuation. In terms of commercial partners, we have not yet announced anything on that front.
Best,
Mark
A close source to GBOX management posted on Stocktwits that GBOX will pursue its token credit revolver platform with or without partner.
According to previous conferences, it was supposed to be a joint venture, so there is a possibility that JV is out of scope.
How do you guys think GBOX is going to raise the $100M seed capital?
Thanks to lone-wolf for the write-up on NEMS
Reminder that GreenBox reported a backlog of 2,000 merchants and given the type of merchants (retailers), we are talking about an average volume of $1M to $2M per merchant.
A point that still remains to clarify is the closing of the ChargeSavvy deal. IR told me it is still not closed and I wonder what may be the reason (they couldn't disclose it to me).
Thanks for the news.
Looks like a similar scenario as for ChargeSavvy: acquiring NE Merchents's portfolio of clients imo
Any thoughts?
It allows for a quicker approval process as the patients should be easier to recruit for phase 3 (inclusion criteria are more defined for Down Syndrom patients. Besides, they are a rather large population).
Annovis will also very probably get Orphan Drug designation.
Maybe it is the share buyback.
I think Ben wants to increase share price to close the ChargeSavvy deal favorably.