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Yet another PR with major news...
This "asset light strategy" will reduce the time it takes to bring products to market, cut production & labor costs and answers a major question of how to reduce VLCN's quarterly burn rate.
VLCN's newest partner GLV Ventures is based in Michigan USA & has 25 years of design & manufacturing experience.
"To improve product margins, the Company has entered into a contract manufacturing agreement with GLV Ventures (GLV), an established automotive supplier and manufacturer. GLV Ventures and its partner companies have been providing sound automotive solutions, superior product development and advanced manufacturing in a timely, cost-effective manner for over 25 years. GLV will produce the Volcon Grunt in both current and future models, as well as the Volcon Stag, the class leading all electric UTV launched by Volcon in July 2022."
https://ir.volcon.com/news-events/press-releases/detail/54/volcon-implements-comprehensive-program-to-improve
Today's PR that "Ted Turner Reserves" is buying a fleet of VLCN Stags was perfect.....
And I'm thinking with pre-orders of $100,000,000 & all of 2023 production ALREADY SOLD OUT that VLCN has several more of these PRs ready to release at their choosing in the near future.
https://ir.volcon.com/news-events/press-releases/detail/53/ted-turner-reserves-places-stag-pre-orders-to-assess
VLCN now has about $32M in cash & with the $100,000,000 in pre-orders future cash raises may be limited if at all.
I really like that the Senior Convertible Notes don't mature until 2024 & "no interest shall accrue".
I don't like the 9.1M warrants but find them tolerable in this case because the exercise price is $2.85.
Considering the overall picture I think this is a definite win for VLCN shareholders.
Yes, he's 83.
GunBroker is recently acquired & only contributed 2 months to the last earnings report. From this point on it will have full quarterly impact.
Historically, GunBroker did ~87% gross margins. If POWW manages to generate two/thirds of its revenue from GunBroker, we could see a total gross margin between 50-70%.
Revenues increased 360% year-over-year to $44.5 million ($12.3 million from GunBroker).
Net Income increased from -$3.1 million to +$9.5 million.
Adjusted EBITDA increased from -$0.3 million to +$16.3 million.
Gross Margin increased from 11.1% to 42.7%.
Revenue backlog of $238 million.
Good analysis in this article:
https://talkmarkets.com/content/stocks--equities/ammo-inc-q1-2022-earnings-recap?post=324831
Excellent news for POWW !
Stellar earnings last week, increased guidance, backorders of $238,000,000 & POWW has a new factory already under construction to handle the rising demand...
And now Biden bans Russian ammo & gun imports. Perfect storm for POWW.
Ok, the April 1 EUA was for antigen test detecting COVID-19 Antigens, Flu A and Flu B.
The new FDA EUA is for COVID-19 antibody test.
https://www.healthline.com/health/infection/antigen-vs-antibody
What's the difference between this FDA EUA & the one that was granted on April 1, 2021? Is it for the same test?
Link to the 7/14/21 zoom call with mgmt.
I love hearing "RCAT does not plan on raising any money with the stock price down here" = no imminent dilution.
Also "RCAT is in great financial shape, we have many years of runway with what we have in the bank right now".
https://us06web.zoom.us/rec/play/DFkai_zXiGno3xSHCD0o7Na-XVazW0RFPkaI3SatdK-GyX1D5o4bjquIh45dvmb-BASsm6UsnuI0uaO-.sHsL54YPT56AmX_v?startTime=1626273016000&_x_zm_rtaid=5FtF1oVPQOmkMUSnvcFGpQ.1626290209744.24e406e8f6d76dfc1230b0693ce3e019&_x_zm_rhtaid=921
Huge endorsement & derisking event for NDRA & their TAEUS technology.
Hepion Pharma commits to using TAEUS in their critical Phase 2b NASH study even though TAEUS has not received FDA 510k Clearance yet??? Unprecedented IMO. This is strong evidence of just large the market for TAEUS will be...
Consider the opinion of someone who is not long NDRA but has done his due diligence. In fact, he is the CEO of another company. And he is bullish on TAEUS:
"Hepion Pharma is excited to incorporate ENDRA's technology into screening for our Phase 2b study of CRV431, which targets non-alcoholic steatohepatitis (NASH) and other liver diseases," said Hepion's CEO Dr. Robert Foster."
"... there is enormous potential value in capturing data on the degree of hepatic steatosis and other biomarkers to refine our understanding of systemic variables associated with NAFLD-NASH. We believe ENDRA's TAEUS system is uniquely designed to accomplish this task for us."
http://investors.endrainc.com/prviewer/release_only/id/4662746
CriTech Research designed the TAEUS software for NDRA.
From the CriTech website: " Our work has a 100% first-time acceptance rate from FDA."
CriTech was founded in 1994, specializes in medical software development, has completed over 450 projects and has 100% submissions approved by both FDA & EU over 27 years of experience.
NDRA submitted its FDA 510k application late June 2020. Likely approval is due anyday now.
Check out the CriTech website:
https://www.critech.com/compliance/
The design & manufacturing of the TAEUS platform is outsourced to Starfish Medical & CriTech Research. NDRA does not plan to bring the manufacturing in-house. NDRA is partnered with GE Healthcare who is helping with marketing & introducing TAEUS to their GE customer base. This is all consistent with NDRA's light asset model business strategy & will greatly reduce manufacturing & commercialization costs.
HUGE for NDRA's TAEUS diagnostic platform:
Rebecca Winderman, MD, Director of the Dept of Pediatric Gastroenterology, Hepatology & Nutrition at Jamaica Hospital Medical Center in Richmond Hill, N.Y. :
"Well this is a bombshell. Huge meta-analysis evaluating some 4,000 patients showed 25% of patients with Non-Alcoholic Fatty Liver Disease (NAFLD) had normal ALT. Numbers weren’t any better for patients who had advanced to Non-Alcoholic Steatohepatitis (NASH) 19% of whom also had normal ALT value."
"We DESPERATELY need non-invasive bio markers for NAFLD and NASH. For now, liver biopsy remains gold standard."
The alanine aminotransferase (ALT) test is a blood test that checks for liver damage... it is unreliable with NAFLD & NASH...
Bottom line, the medical community is desperate for the TAEUS technology which is approved for CE Mark in Europe & pending FDA 510k approval.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6961232/
Volume Precedes Price...
NDRA set a record for the highest volume day in its history last Tuesday 1/19/21 with 18 million shares traded only for the record to be broken the very next day with 33 million traded. That wasn't day traders, it was accumulation as witnessed by the share price not only holding but increasing in the following days. NDRA also had 4 Fidelity Funds buying shares for the first time recently. In addition, the NDRAW volume has surged this past week after being DOA in 2020. This is Very Bullish action.
The FDA 510k submission was June 2020 & everyone knows the likely approval is coming sooner than later, whether it is this week or next month. It will be a game changer for NDRA & sales will soon follow.
Tuesday will be the 10th consecutive day closing at $1.00 or above so NASDAQ compliance is in sight...
The funds & investors currently buying NDRA are not scared of the daily chart. Yea, the share price has doubled this past week. Some are waiting for the trap door to open with a major price drop but it hasn't happened. Instead, the share price is rising... Why? Look at NDRA's market capitalization of $88 million...that is tiny. NDRA has leading edge technology in its TAEUS platform that will be 50X cheaper than MRI. NDRA already has a Vietnam distribution agreement signed. NDRA is partnered with GE Healthcare. With FDA 510k approval NDRA will be worth a market cap of $200 million to $300 million.
The daily chart is important but the share volume & market capitalization is where the truth lies...
Wanna know how screwed the remaining short sellers are?
They have been waiting 2 weeks for a dilution PR. It finally came when BNGO was at its weakest momentum since this rally started. And those sorry F's could not even fill the last gap before BNGO ran up to $5.08 after hours to finish Green on a Dilution Day !
To make matters worse, BNGO was up +8% after hours so we are likely going to have another price gap up on Monday...
LMFAO...
Monday BNGO will have SSR & the Next-Generation Cytogenomics Symposium all week...
Tuesday we will have news of the offering closing & it will also be 10 days at $1.00+ so BNGO will be off of the NASDAQ compliance shit list.
BNGO ALREADY has an At The Market Equity Program for common shares & warrants in place. It was already filed & PRd on August 17. BNGO can use it as needed with no more SEC filings or PRs about "dilution".
https://www.globenewswire.com/news-release/2020/08/17/2079241/0/en/Bionano-Genomics-Announces-At-The-Market-Equity-Program.html
BNGO had $19M cash plus warrants last CC. No need for urgent cash raising. Let the stock run, regain compliance & sell some shares into the market when needed IMO.
BNGO has Superior Technology, it is the future of medicine.
Make a small time investment to learn a lot:
New, Detailed & Very Bullish BCRX SA Article by Thomas Cheatham. This article does a good job of explaining to retail investors why the institutions are suddenly marking up the BCRX share price so aggressively.
https://seekingalpha.com/article/4393550-biocryst-time-to-switch-hats-mid-cap-fits-now-maybe-large-cap
"Adding up the Orladeyo $5.635B plus the Galidesivir $500M plus the RAPIVAB $150M and rounding out with the current BCX9930 $1B valuation you get a current total valuation of $7.285B. That's deep in mid cap country my friends. Factor D, BCX9930, paves the road to large cap status. Large cap status is $10B or more and honestly, we see Factor D being able to pull all that weight by itself in the future and looking at a total of possibly $17.285B in market cap when all cylinders are finally running in tandem.
**Current BCRX valuation fully diluted: $36.43 PPS**
**BCRX valuation full throttle: $86.43**
Again, all this given ultra conservative numbers and backed by deep market research, a dire unmet need for an oral option, and massive potential from clinical studies."
Congrats BCRX Longs !!!
Remember the gap BCRX has at $7.20 from 5/20/19. Now that Berotralstat/Orladeyo is APPROVED that gap WILL be filled. Maybe not tomorrow but with the multiple catalysts & revenue on deck it will happen in the near future.
With Institutions holding about 90% of the float they can do as they please with the share price given the right catalyst & demand exceeding supply, plus fuel from the large short interest covering.
**CATALYSTS Q4 & Q1**
*Bero/Orladeyo FDA Approved!
*Orladeyo granted Early Access by UK's MHRA
*Bero/Orladeyo Japanese approval - Waiting on official decision from Japanese Ministry of Health in Dec 2020.
Japanese ADCOM already recommended approval.
*Galidesivir antiviral COVID-19 Brazilian clinical trial, Part 1 data Dec 2020
*BCX9250 Fibrodysplasia Ossificans Progressiva (FOP)P1 data Q4
*BCX9930 Factor D 200/400mg Cohort 2 data Q1
*Bero/Orladeyo EU approval decision 2021
*RAPIVAB possible flu stockpile orders.
What if there is No Dilution??? Stonehouse directly addressed the BCRX cash position for the 3rd+ CC in a row on today's Evercore ISI call:
https://wsw.com/webcast/evercore11/bcrx/2358195
Stonehouse emphasized the strong BCRX cash position into 2021.
$149,000,000 cash on hand, the coming $20,000,000 milestone payment from Torii Pharma, the existing $46,000,000 credit line & the Berotralstat/Orlaydeo sales force is ready to start generating sales pronto upon Dec 3 approval.
Stonehouse once again pointed out the multiple alternatives instead of issuing more shares & he discussed other funding options available to the company including bonds, debt, royalty financing and partnerships.
Shorts are screwed, they have been expecting a BCRX dilution event Q4 2020 to cover their short positions, approximately 20% of the outstanding shares. It ain't happening!
The best clue is CFO Doyle spending half his annual salary to buy BCRX shares on the open market. No CFO would do that if he felt share dilution is likely.
https://seekingalpha.com/news/3604911-biocryst-pharmaplus-5-cfo-buys-220000-worth
The shorts who are not hedged with a BCRX long position are now shorting more to keep a lid on the share price & praying that Orladeyo sales are soft. They are very vulnerable to good Orladeyo sales news but also surprise Galidesivir news, BCX9250 Fibrodysplasia Ossificans Progressiva (FOP) P1 data & the next BCX9930 Factor D inhibitor update.
IMO this is why the BCRX PDUFA is different from other smallcap biotech PDUFA's: BCRX already has a HAE experienced sales team hired, trained & contacting future customers.
Immediate sales following approval will quickly support the share price & The Sales Are "Pandemic Proof"...
BCRX will be printing $$$ in December with Orladeyo approval.
"We Are Ready To Launch The Day Orladeyo Is Approved"
"50% of patients in the Berotralstat/Orladeyo long term safety study are switching from Takhzyro & Haegarda to Orladeyo"
Estimate about 150-200 initial patients from Day 1 post approval.
Assuming likely Bero/Orladeyo approval with Dec 3 PDUFA (or sooner...) if we use the lower $500,000 price per patient per year estimate about $42,000 per month per patient. If 200 initial patients BCRX will start off with a minimum of $8,400,000 monthly revenue in December/January & build from there. Perhaps $100,000,000+ annual sales "guaranteed" from Day 1.
https://clinicaltrials.gov/ct2/show/NCT03472040?id=NCT03891420+OR+NCT04330534+OR+NCT03472040+OR+NCT03873116+OR+NCT04428632+OR+NCT03485911&draw=2&rank=6&load=cart
Also, CEO Stonehouse mentioned the feedback from the insurance companies has been very positive if the Orladeyo pricing stays in the same $500,000 to $600,000 per patient per year range that the competitors charge.
From 11/5/20 CC:
"We're also invested in understanding how payers will cover Orladeyo, and how we will help customers through the access process. A year ago, we did qualitative interviews with 16 payers representing over 100 million covered lives. And since then we completed additional quantitative work with 56 payers that represent over 200 million covered lives. Payer feedback has been consistent. They recognize the value of an oral therapy for HAE patients, but they don't want to pay a premium for it. They tell us, they will cover Orladeyo, if it costs them what they pay for injectable therapies like Haegarda and Takhzyro products that are priced at $500,000 to $600,000 per year."
This early FDA approval was posted at 7:42pm on the ST ALNY forum for the drug Oxlumo (lumasiran).
https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-rare-metabolic-disorder
FYI their PDUFA date is December 3, same as Berotralstat/Orladeyo.
FDA is ahead of schedule, be ready BCRXers...
https://www.biopharmcatalyst.com/calendars/pdufa-calendar
CCO Charlie Gayer 11/5/20 CC: "We Are Ready To Launch The Day Orladeyo Is Approved."
"Patients & physicians told us consistently that they see a targeted oral therapy as the next big thing and the natural evolution of HAE therapy. This explains why half the patients we surveyed, who say they are very satisfied on their injectable therapies, still want to switch to ORLADEYO.
"We've seen this movement already as 50% of the patients enrolling in APeX-S in the USA are switching from treating with Takhzyro, Haegarda or Cinryze."
"Insurance payer feedback has been consistent, they will cover Orladeyo, if it costs them what they pay for injectable therapies like Haegarda & Takhzyro products that are priced at $500,000 to $600,000 per year."
So, after Dec 3 Orladeyo approval BCRX already has 200+ patients signed up & insurance approval. The transformation to a revenue producing company will be immediate, plus $20M milestone payment from Torii Pharma.
https://clinicaltrials.gov/ct2/show/NCT03472040?id=NCT03891420+OR+NCT04330534+OR+NCT03472040+OR+NCT03873116+OR+NCT04428632+OR+NCT03485911&draw=2&rank=6&load=cart
IMO shorts have been expecting a BCRX dilution event Q4 2020 to be the best opportunity to cover their short positions, approximately 20% of the outstanding shares.
But what if there's No Dilution???
CEO Stonehouse directly addressed the BCRX cash position in the Wainwright CC 9/14/2020.
https://wsw.com/webcast/hcw7/register.aspx?conf=hcw7&page=bcrx&url=https://wsw.com/webcast/hcw7/bcrx/1607095
Stonehouse emphasized the strong BCRX cash position. When pointing out there are multiple alternatives instead of issuing more shares Stonehouse discussed other funding options available to the company including bonds, debt, royalty financing and partnerships.
Stonehouse mentioned $192,000,000 cash on hand, the coming $20,000,000 milestone payment from Torii Pharma, the existing $50,000,000 credit line & that the Berotralstat/Orlaydeo sales force is ready to start generating sales immediately upon approval.
BCRX also recently received a RAPIVAB order for $7,000,000 & another $47,000,000 from NIAID for Galidesivir COVID-19 development.
https://ir.biocryst.com/static-files/c88e6cab-358f-4187-bac7-6384d8a73cf0
BCRX accumulation = a tutorial on the Wyckoff Method
https://school.stockcharts.com/doku.php?id=market_analysis:the_wyckoff_method
Let's try this again with active links lol
*Recent Highlights*
*Investor Presentation
https://ir.biocryst.com/static-files/c88e6cab-358f-4187-bac7-6384d8a73cf0
*Sept 8 - UFla researchers confirm Galidesivir promise vs COVID-19
https://ufhealth.org/news/2020/trio-medications-showing-early-promise-against-coronavirus-uf-health-researchers-find
*Sept 3 - US Govt buys RAPIVAB for strategic stockpile
https://ir.biocryst.com/node/21631/pdf
*Aug 31 - NIAID grants another $47 million for Galidesivir antiviral development
https://ir.biocryst.com/node/21596/pdf
*Aug 31 - FDA grants Orphan Drug status for oral Factor D inhibitor BCX9930
https://ir.biocryst.com/node/21581/pdf
*Aug 3- FDA grants Fast Track status for oral Factor D inhibitor BCX9930
https://ir.biocryst.com/node/21516/pdf
The non human primate trials for Galidesivir COVID-19 are confirmed by BCRX but the company offers no timeline info. Any comments, including mine, on data release is speculation based on the NIAID purchases of Galidesivir, the timing of the additional $47 million NIAID Gali funding & the email/Twitter clues from the O'Connor/Whitney primate labs. I also believe the monkey data will be released prior to the Brazilian Part 1 data.
BCRX has stated the Brazilian Galidesivir COVID-19 Part 1 data is now due Q4 2020, October is the first month of Q4 & IMO the most likely release date since it is prior to the election.
**Recent Highlights**:
*Investor Presentation:
ir.biocryst.com/static-file...
*Sept 8 - UFla researchers confirm Galidesivir promise vs COVID-19
ufhealth.org/news/2020/trio...
*Sept 3 - US Govt buys RAPIVAB for strategic stockpile
ir.biocryst.com/node/21631/pdf
*Aug 31 - NIAID grants another $47 million for Galidesivir antiviral development
ir.biocryst.com/node/21596/pdf
*Aug 31 - FDA grants Orphan Drug status for oral Factor D inhibitor BCX9930
ir.biocryst.com/node/21581/pdf
*Aug 3- FDA grants Fast Track status for oral Factor D inhibitor BCX9930
ir.biocryst.com/node/21516/pdf
**MINIMUM 6 CATALYSTS SEPT thru DEC 2020**
*Galidesivir COVID-19 non human primate trials data due anyday
*Galidesivir COVID-19 human trial Part 1 Data due Oct
*Berotralstat Japanese approval Q4
*Berotralstat FDA PDUFA Dec 3
*BCX9930 Factor D 200/400mg Cohort 2 data Sept
*BCX9930 Factor D 200/400mg poor responder PNH data Q4
*BCX9250 Fibrodysplasia Ossificans Progressiva (FOP) P1 data Q4
*RAPIVAB more possible flu stockpile orders
*More Institutional buying: Two Sigma added 23k shares in Sept
There are now 51 Institutional filings for ATNM purchases since July & only 8 filings since July for sales.
Why are BlackRock, Vanguard, Citadel, etc buying now?
https://fintel.io/sob/us/atnm
*ATNM Investor Presentation:
https://d1io3yog0oux5.cloudfront.net/_a97b700c6679b4e86cb751a3855e3a5e/actiniumpharma/db/206/944/pdf/Actinium_Investor+Presentation_September2020.pdf
*The Iomab-B SIERRA clinical trial Ad Hoc Analysis option was exercised during Q2 2020, results due 2H 2020
*CEO Seth: "We look forward to updates from all three trials by year end"
*Timing is critical & the ATNM bullish thesis is now compelling with its small $140 million market capitalization
*ATNM has some $60+ analyst price targets for a very good pipeline
https://www.tipranks.com/stocks/atnm/forecast
*Actimab-A CLAG-M Combo Phase 1 trial successful
https://ir.actiniumpharma.com/press-releases/detail/365/actinium-pharmaceuticals-announces-successful-completion-of
*Actimab A has multiple pending catalysts 2H 2020
*ATNM raised $25 million in June to support cash position
*ATNM recently executed 1 for 30 reverse stock split
*Outstanding shares now only 13.6 million
*Insiders filed 8 SEC Form 4 for stock option purchases August 14
AstraZeneca Covid-19 vaccine study put on hold due to suspected adverse reaction in participant in the U.K.
https://www.statnews.com/2020/09/08/astrazeneca-covid-19-vaccine-study-put-on-hold-due-to-suspected-adverse-reaction-in-participant-in-the-u-k/
U of Fla health researchers: "So far, two of the drugs — Remdesivir and Galidesivir — have shown noteworthy activity in suppressing the virus, Brown said. Favipirivir has been less effective than the other two compounds."
https://ufhealth.org/news/2020/trio-medications-showing-early-promise-against-coronavirus-uf-health-researchers-find
Read the 8/31/20 BCRX Galidesivir PR: "Conducting a Phase 2 Clinical Trial (NOT the Brazilian trial, IN ADDITION TO...) of Galidesivir in non-hospitalized COVID-19 patients at high risk for developing severe disease and complications of COVID-19."
https://ir.biocryst.com/node/21596/pdf
The PR does not say "will conduct". It specifically states "conducting a Phase 2 clinical trial of Galidesivir in non-hospitalized COVID-19 patients" as in another Galidesivir trial is already happening in the USA as part of Operation Warp Speed...
That statement fits perfectly with the ACTIV-2 COVID-19 therapeutic clinical trials sponsored by NIAID, the same agency that just gave BCRX another $47,000,000 for Galidesivir development...
https://www.newswise.com/coronavirus/actg-announces-launch-of-novel-clinical-trial-testing-multiple-therapeutics-to-treat-covid-19/?article_id=735820
BCRX potentially now has 3 "shots on goal" with antiviral Galidesivir for COVID-19:
1) Non human primate trials & Emergency Use Authorization thru FDA Animal Rule
2) Brazilian human clinical trial
3) NIAID sponsored ACTIV-2 phase 2 COVID-19 trial that is part of NIH Operation Warp Speed initiative.
We should definitely get some more Galidesivir news late September/early October.
I still think the FDA Animal Rule will be used for Galidesivir Emergency Use Authorization.
When using the Animal Rule a drug's safety must be confirmed with human trials. Notice that SAFETY, not efficacy, is the primary endpoint for the Galidesivir Brazilian COVID-19 trial? The safety primary endpoint was emphasized in the 8/31/20 Galidesivir NIAID funding PR. Primate studies were also mentioned.
Efficacy (the effectiveness of Galidesivir) verses COVID-19 must be proven with the primate trials. Then BCRX can combine the safety & efficacy results of Galidesivir verses COVID-19 to satisfy the FDA Animal Rule. It is easily the fastest path to EUA & approval.
*Many FDA Approved Drugs & Biologics have been approved under the Animal Rule*:
Raxibacumab (Approved on 2012-12-14)
LEVAQUIN (Approved on 1996-12-20)
Pyridostigmine Bromide (Approved on 2015-02-05)
Cyanokit (Approved on 2006-12-15)
*SIGA's Tpoxx is FDA approved thru the Animal Rule*
https://pink.pharmaintelligence.informa.com/PS123004/Animals-Rule-SIGAs-Smallpox-Drug-Tecovirimat-Sails-Through-US-FDA-Panel
Timing is critical...
*The Iomab-B SIERRA clinical trial Ad Hoc Analysis option was exercised during Q2 2020, data & results due 2H 2020.
*Actimab A has multiple pending catalysts 2H 2020
*ATNM raised $25 million in June to support cash position.
*40 Institutions suddenly decide to buy ATNM since July including BlackRock, Vanguard, Citadel, Consonance, Renaissance, etc.
*ATNM announces 1 for 30 reverse stock split
*Outstanding shares now only 13.6 million
*Insiders filed 8 SEC Form 4 for stock option purchases on August 14
*It has been 130 days since a pipeline PR was released........
I believe not having any Galidesivir news by now is very bullish. The negative news delivered today on blood plasma is a good example why. Blood plasma is a poor COVID-19 therapeutic so the negative news was delivered fast. If Gali was a bust verses COVID-19 we would have heard the negative news by now. Instead, it is BCRX Crickets & the Gali COVID-19 primate & human clinical trials continue because the drug works, IMO.
Remember that Galidesivir is a broad spectrum antiviral & has done well verses multiple viruses including Ebola & Zika. COVID-19 will soon be added to the Gali list:
https://ir.biocryst.com/node/21441/pdf
Check this out, even Regeneron & Eli Lilly COVID-19 clinical trials are being delayed a few months.
The Regeneron & Eli Lilly researchers sound like the reports we have heard from Brazil.
Delays getting COVID-19 test results, overwhelmed hospitals with staffing shortages, patient space constraints and reluctant patients who either fear getting a placebo or fear getting an experimental drug.
“That doesn’t happen when you’re setting up diabetes trials or cancer trials,” he said. “We’ve had investigators say, ‘Look, I’d love to do research, but I don’t have time to set up a new trial. I’ve got an ICU full of patients.”
https://news.yahoo.com/clinical-trials-coronavirus-drugs-taking-185924249.html
Stonehouse is a Merck alum.
Yes, GR8 Factor D inhibitor FDA Fast Track news. Stonehouse is going to soften up the short sellers with Factor D & Berotralstat news first then knock them out with Galidesivir FDA Emergency Use Authorization...
CEO says Galidesivir & Berotralstat news "this summer"
Galidesivir+Berotralstat+Factor D+Rapivab = $20+
1) Berotralstat Japanese Sakigake approval expected 3Q 2020, BCRX will receive $20M milestone from partner Torii
2) Berotralstat HAE Expanded Access Program initiated, PDUFA Dec 2020
https://ir.biocryst.com/node/21431/pdf
3) BCRX hires 16 HAE managers/sales reps from
competitor Takeda for Berotralstat commercialization
4) Rapivab approved for Flu
https://www.biocryst.com/our-program/rapivab/
5) Galidesivir COVID-19 clinical trial news due this summer, Gali beats Ebola & Zika viruses
https://www.researchgate.net/publication/320203179_Efficacy_of_Galidesivir_against_Ebola_Virus_Disease_in_Rhesus_Monkeys
https://ir.biocryst.com/news-releases/news-release-details/galidesivir-stops-zika-viral-replication-primate-model
7) Galidesivir COVID-19 animal study news overdue, FDA Animal Rule another path for Gali Emergency Use
Authorization.
8) Oral Factor D inhibitor "pipeline in a molecule" for complement-mediated diseases granted FDA Fast Track
https://ir.biocryst.com/node/21516/pdf
9)FOP Connective Tissue Disease Phase 1 results 2H
2020
https://www.webmd.com/children/what-is-fop#1
10) $220M Cash On Hand last update
11) Insider Trading Report
https://fintel.io/n/us/bcrx
Dr Fauci July 16 when asked about therapeutics:
"Some of the promising ones are other direct Antiviral drugs which we are screening & targeting."
These are the top Antiviral contenders that I know of:
1) Galidesivir - Non toxic, superior safety profile including children, broad spectrum antiviral, can be given as pill, IM, IV or nasal.
https://ir.biocryst.com/news-releases/news-release-details/galidesivir-stops-zika-viral-replication-primate-model
https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-020-02439-0
2) EIDD 2801 - is a ribonucleotide, drugs in the same class have caused serious reproductive problems in animals, with animals exposed in the womb born without teeth and with partially formed skulls.
https://theintercept.com/2020/05/12/richard-bright-barda-coronavirus-whistleblower/?ref=hvper.com
3) Baricitinib - has Boxed Warnings
https://www.drugs.com/cdi/baricitinib.html
4) Favipiravir - Birth defects, Liver damage
https://theprint.in/health/favipiravir-japanese-drug-thats-the-new-covid-treatment-hope-your-chemist-will-soon-stock/447987/
5) Avigan - Birth defects, Liver damage
https://www.thejakartapost.com/news/2020/05/26/japan-gives-up-approving-fujifilms-avigan-drug-for-covid-19-by-may-end-kyodo.html
This government contract is listed as a new PR on TD Ameritrade, not sure what you are referring to.