is...optimistic for the future of CNS conditions thanks to Anavex Life Sciences.
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Growth market for AMD, both wet and dry...
https://www.industryarc.com/Research/Age-Related-Macular-Degeneration-Market-Research-502356
https://www.globaldata.com/global-age-related-macular-degeneration-market-will-more-than-double-in-size-by-2028/
https://www.marketresearchfuture.com/reports/age-related-macular-degeneration-market-5736
https://www.medrxiv.org/content/10.1101/2021.05.13.21256639v1
"Conclusion: A two-dose regimen of NVX-CoV2373 conferred 89.7% protection against a blend of prototype and variant Covid-19, demonstrated high efficacy against the B.1.1.7 variant, and had a reassuring safety profile."
Despite the attention and focus on COVID, there is still the specter of MRSA...
https://www.pharmiweb.com/press-release/2021-03-25/methicillin-resistant-staphylococcus-aureus-market-size-is-estimated-to-reach-us-1-3279-million-by
And Brilacidin is one of the few candidates to be effective.
Further potential. I wonder how many other indications are being found through RBL testing?
“Tired of Pricks?”
https://finance.yahoo.com/news/mannkind-announces-partnership-type-1-130000665.html
Tired of the same old FUD and bash crowd, but there might be a receptive IndyCar audience willing to give Afrezza a try instead of continued injections.
https://isvcongress.org/default.php
Dear ISV Members, Colleagues and Friends,
We are pleased to announce that the ISV Virtual Congress - 6th COVID-19 Vaccine Update will be held on Tuesday, May 25th at 9:00am (Eastern Time).
The 6th Congress in the COVID-19 vaccines series will host Drs. Hanneke Schuitemaker (Janssen) and Greg Glenn (Novavax) who will be providing updates on the development of their COVID-19 vaccine candidates. The Congress includes an mRNA vaccine safety session with Dr. Mariana Castells (Brigham and Women’s Hospital) which will focus on local and systematic hypersensitivity. We are also planning a session on vaccine variants with more speakers to be announced. You may view the program below.
Pre-congress registration is required. You may register by clicking the “REGISTER HERE” link below and at https://isvcongress.org/.
As in the previous ISV Virtual Congresses, the Microsoft Teams platform will be used to host the Virtual Congress. For the best viewing experience we recommend you download the Desktop Application HERE prior to the meeting.
There is an inhaled powder delivery platform by MannKind.
https://pipeline.unither.com/wp-content/uploads/2020/04/6_SD2018_TECHNOSPHERE_Michael_Castagna_FINAL_0924.pdf
Seems ideal.
MC- "And we're looking forward to hopefully having an acceptance from the FDA with ILD later this quarter in approval by year end. On the pipeline side, we completed our first toxicology studies for clofazimine, which is MNKD-101."
Looks like leprosy and tuberculosis treatment potential?
"Clofazimine is a highly lipophilic antimicrobial riminophenazine dye used in combination with other agents, such as dapsone, for the treatment of leprosy. It was originally described in 1957 and was the prototypical riminophenazine dye - a bright-red dye that, in its clinical use, results in long-lasting discoloration of the skin and bodily fluids.2 Although it carries in vitro activity against other mycobacterium, such as Mycobacterium tuberculosis, it is generally considered an ineffective treatment in comparison to classic tuberculosis treatments such as rifampicin and isoniazid."
Seems that would involve digestive processes, enzymes, etc which could affect absorption rates, etc.
IV administration is direct to blood.
Can't help but wonder about either Technosphere delivery or nebulizing Brilacidin for a direct-through-lungs approach.
In this patient group I would expect some deaths in both groups. The question is whether or not there are more deaths in one group compared to the other.
Bingo.
Adverse Effects...
Consider colistin.
"Colistin, also known as polymyxin E, is an antibiotic medication used as a last-resort treatment for multidrug-resistant Gram negative infections including pneumonia."
https://www.rxlist.com/consumer_coly_mycin_m_colistin/drugs-condition.htm
Will/would there be similar effects at certain dosages with Brilacidin? Maybe, but we aren't privy to that yet.
There was not a stop placed on Brilacidin trials. We know of no patient deaths through press releases. We know that the treatments have been pushed to 5 days vs. 3. Enrollment continues.
Plenty of unknowns to we the shareholders, but there are actual patients receiving Brilacidin, and apparently they aren't dead unless that becomes disclosed information months from now.
It would seem there may be benefits occurring in patients now, experiencing the brunt of COVID in real time.
Here's an anecdote related to IVM...
https://olhardigital.com.br/en/2021/01/08/coronavirus/sem-eficacia-contra-covid-19-ivermectina-tem-boom-de-vendas-em-2020/
"Desperate to fight the pandemic of coronavirus, Brazilians were supported in an unbridled search for the vermifuge ivermectin last year. According to data from IQVA, the sale of the product on the market pharmaceutical exploded from January to November 2020, growing 466% over the same period in 2019.
The data show that around 42,3 million boxes of antiparasitic were sold last year. The peak in purchases was observed in July, when more than 12 million acquisitions of invermectin were added."
So yeah...Brilacidin stands a very good chance of being the go-to treatment when ivermectin isn't even a proven treatment.
SOLID.
"NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated 100% protection against severe disease, efficacy of 96.4% against the original virus strain, 86.3% against the B.1.1.7/501Y.V1 variant and 89.7% overall; and the PREVENT-19 trial in the U.S. and Mexico that began in December 2020. It is also being tested in two ongoing Phase 2 studies that began in August 2020: A Phase 2b trial in South Africa that demonstrated 100% protection against severe disease and 48.6% efficacy against a newly emerging escape variant first described in South Africa, and a Phase 1/2 continuation in the U.S. and Australia."
With limited tweaking of future batches, the variants could be accounted for too!
Think of THAT!
And not just as a post-exposure prophylaxis, but as a treatment/therapeutic.
And how many other possibilities?
Although it's been touched on before, Brilacidin SI = 426
For comparison's sake with Veklury, see slides 19 and 20...
https://www.sidp.org/resources/Documents/COVID19/Matt%20Davis%20Handouts%209.5.2020.pdf
Good things are nigh.
Why Novavax will be the best in class...
“The 60% reduced risk against COVID-19 illness in vaccinated individuals in South Africans underscores the value of this vaccine to prevent illness from the highly worrisome variant currently circulating in South Africa, and which is spreading globally. This is the first COVID-19 vaccine for which we now have objective evidence that it protects against the variant dominating in South Africa,” says Professor Shabir Maddi, Executive Director of the Vaccines and Infectious Diseases Analytics Research Unit (VIDA) at Wits, and principal investigator in the Novavax COVID-19 vaccine trial in South Africa.
“I am encouraged to see that Novavax plans to immediately begin clinical development on a vaccine specifically targeted to the variant, which together with the current vaccine is likely to form the cornerstone of the fight against COVID-19.”
Will this be The Week?
GSK collab. Nice.
Drug-resistant tuberculosis in Russia...
https://www.ncbi.nlm.nih.gov/books/NBK62453/
What if Brilacidin shows efficacy against drug-resistant strains of tuberculosis during trials in Russia?
(Especially considering findings in 2014 concerning MRSA)
http://outbreaknewstoday.com/novel-mrsa-antibiotic-brilacidin-receives-positive-review-in-phase-iib-safety-study-88944/
What if, 8 years after its acquisition, Brilacidin finally shows its potential?
"The acquisition includes PolyMedix' flagship drug candidate brilacidin (PMX-30063), a first-in-class defensin-mimetic antibiotic that has completed a Phase IIa clinical trial demonstrating safety, tolerability and efficacy in patients with acute bacterial skin and skin structure infections (ABSSSI) caused by Staphylococcus aureus. In the clinical trial, brilacidin hit its primary endpoints with high and low doses outperforming Cubist Pharmaceuticals' Cubicin (daptomycin) in the control arm of the study."
Here we are. 8 years later. Looking at a critical turning point in a global pandemic with many positive indications. Vaccines are not the final answer due to viral mutations creating life threatening variants. Remdesivir is not a silver bullet in the therapeutic section, but there are plenty of positive indications for Brilacidin's mechanisms of action.
Results await!
Looking forward to 500+% of $15.68.
When the trifecta hits, even that will be considered low ($78+).
Truth is that an effective therapeutic will be priceless.
If Brilacidin comes through as a broad spectrum therapeutic, it will not only be the new go-to for coronavirus variants, but many other infectious diseases as well.
Trifecta is coming.
Hold your horses.
This needs a Macho Man Randy Savage image.
OH YEEEAAAAAAHHHHHH!
Results await.
Buying time is here.
At least the timing is good.
"Our Technosphere platform we expect additional opportunities with partners as we're working on 10 different molecules here, some for Mannkind, some for partners, but we expect continued opportunities on Technosphere platform in the coming years."
Plus the FDA feedback. Type I & II pediatric approval would be a coup.
I don't mind sale prices...
...when the payoff will be pediatric approval and a host of other developments.
How Novavax uses moth cells to create its coronavirus vaccine https://t.co/w944hdH7C9
— K_Conner (@kvconner) March 8, 2021
Brilacidin...the semiconductor of therapeutics!
Thanks Lemoncat. I appreciate the lesson.
Is there a limit?
What’s the maximum # of significant digits to the right of the decimal for trading, or is there one? 6 places?
Would the quants push it to 7, 8, or 9 just to F with retail investors and manipulate the share price?
Saw these...
https://www.sec.gov/rules/concept/34-44568.htm
https://www.investopedia.com/terms/d/decimal-trading.asp
Let them be fitted with colostomy bags.
Brilacidin...first for COVID, then other viruses.
Spread of S. African variant in eastern France triggers calls to suspend AstraZeneca vaccine rollout to health workers
https://www.washingtonpost.com/world/spread-of-s-african-variant-in-eastern-france-triggers-calls-to-suspend-astrazeneca-vaccine-rollout-to-health-workers/2021/02/16/162f8932-7060-11eb-8651-6d3091eac63f_story.html
At least Novavax is already positioned for multivalent tweaking of its formula.
And which vaccine(s) did they receive?
Though, of course, it still shows how vital a therapeutic (Brilacidin) is in the grand scheme of things.
Antifungal. Antibacterial. Antiviral. Antinflammatory.
Good call.
Just a player out there with more dry powder than me.
GLTAL!!!
Wish it could have been named ‘Penetratesevir’ rather than Brilacidin.
Just spitballin’...
Like I said...that’s a substantial position taken at roughly $7-9 million depending on what lots were purchased at what time and the address in question being listed as a pizza/ TDAmeritrade building is odd. John Miller is a pretty generic name as well. You got some better ideas?
What if...
....”Kips Bay Select LP” is simply a shell corporation allowing a larger entity, e.g. BlackRock, to amass a position while the stock is under $5/share?
https://www.investopedia.com/terms/s/shellcorporation.asp
20,978,229 shares of Common Stock Class A is a substantial position.
Did Gilead create an alias to allow for a significant buy-in with IPIX (for Brilacidin) that could be used synergistically with remdesivir in the not-too-distant future?
Given the cost of remdesivir, I wonder what pricing of brilacidin would be?
https://www.ajmc.com/view/gilead-sciences-sets-us-price-for-covid19-drug-at-2340-to-3120-based-on-insurance
“ Gilead Sciences Monday set the price for remdesivir, its antiviral drug that can shorten hospitalization stays for individuals ill with coronavirus disease 2019 (COVID-19) from SARS-CoV-2 infection, at $520 a vial, or $3120 per patient for a typical treatment course, for those with private insurance.
The price those not covered by private insurance will be $390 per vial. A treatment course is 6 vials. The FDA approved the drug for emergency use in some patients and the company has applied for full approval.
The Institute for Clinical and Economic Review (ICER) last week said remdesivir would be cost-effective at a price range of $4580 to $5080 if it saved lives. However, news that an inexpensive steroid, dexamethasone, which does not have a patent, improves survival means remdesivir should be priced between $2520 and $2800, ICER said.”
Big Picture hypothesis...
When the RBL tested Brilacidin (in vitro and in vero) and had such outstanding results against one strain of novel coronavirus, what OTHER viral, bacterial, and fungal arrangements did they start thinking about for future testing?
Brilacidin is NOT a one trick pony. It has broad spectrum applications. So many people are zeroed in on COVID that they don’t realize Brilacidin is representative of an entire new class of drugs beyond just antibiotics.
Consider the findings thus far...
https://www.biorxiv.org/content/10.1101/2020.10.29.352450v1.full
Sounds like either Pfizer or Gilead could sure use a “win”...