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Let's see 2.00+ next Monday !
Solid upside moves this week !
How much does it cost to power charge a Tesla? That is down about 85% on it power availability.
This is may be an additional revenue source for Tesla.
Tesla expands Supercharger access to non-Tesla EVs in Italy, now covers most of Europe:
https://electrek.co/2022/11/18/tesla-supercharger-expand-access-non-tesla-evs-italy-covers-most-europe/
Well that was me on biz from NY. Damn good food!
Not sure...I'm a Paganos man. South Street is darn good, but really for more of the "tourist" crowd.
is Jim's Philly Steak on South St. open? One of the best in my opinion.
Tutes will be accumulating around 2:00 pm est. each afternoon . Instutions jumping on board.
Probably sold , & bought a philly cheese steak! lol
WLAN is a nice upside mover!
CMTX is a nice multi day mover. Up 10% @ 1.76
CTMX—(+25%)—inks REGN drug-discovery collaboration—$30M up-front cash:
https://www.globenewswire.com/news-release/2022/11/17/2558024/37704/en/CytomX-and-Regeneron-Announce-Strategic-Research-Collaboration-in-the-Field-of-Conditional-Bispecific-Therapeutics-for-the-Treatment-of-Cancer.html
Potential for up to $2 billion in research, development, regulatory and sales-based milestones .
Cryptocurrency brokerages Gemini and Genesis are reassuring people that their operations are still solvent after the massive collapse of exchange FTX.
The insolvency of FTX could result in more companies in the industry facing severe liquidity issues, including crypto exchanges and lenders.
Gemini, the exchange founded by the Winklevoss twins, is attempting to calm crypto investors. The exchange said on Wednesday that it would halt withdrawals on its Earn accounts that provide interest. The lending partner for the Earn accounts is Genesis.
Let's go CTMX !!!!!
Agree! Going to stellar heights in upcoming sessions.
CTMX
That's the trump card that will ignite share price big time!
Crude - at a billion MC what happens when Merck and ketruda take a 20% interest?
Ivy League endowment funds, pension plans, and mutual funds all over CMTX.
Tutes will continue to accumulate shares.
CTMX is a great multi-dollars opportunity.
Wow, huge catalysts !!!!!
CTMX
Did a bit of due diligence and reviewed the
quarterly filing and I am still stunned this is
still only 1.60… PRIOR to that unbelievable PR
yesterday …
- only 66 million outstanding shares
- 90 million in cash !!!!?
- zero dilution
- already has a contract with BRISTOL MEYERS
($70 stock, over hundred billion MC)
-already has a contract with ABBVIE
($170 stock, over hundred billion MC)
-revenue generating, 16 m per qtr
and on top of that yesterday’s news with
Regeneron ($700 stock) and CTMX is getting
30 million from Regeneron!!!!!!?
I am not in. Too many potential roadblocks.
A kidney disease drug that seemed to have little likelihood of receiving Food and Drug Administration approval received an unexpected boost late Thursday, when a committee of the agency's outside advisors voted in favor of the proposition that the drug's benefits outweigh its risks.
The drug, Ardelyx's (ARDX) tenapanor, is under consideration for FDA approval as a treatment for elevated levels of serum phosphorus in the blood of chronic kidney disease patients receiving dialysis. The drug is already approved as a treatment for constipation in patients with irritable bowel syndrome, and marketed under the name Ibsrela.
The FDA's advisors voted nine to four in favor of the risk-benefit profile of tenapanor administered alone to treat high serum phosphorus levels, and 10 to two in favor of its risk-benefit profile in combination with a drug known as a phosphate binder.
Investors had attributed low odds to the drug receiving FDA approval, and the agency isn't required to follow the advisory committee's guidance. What's more, given the lengthy and unusual path the drug has taken so far through the FDA's approval process, the path ahead for the drug is complicated, and somewhat hazy.
Still, shares of Ardelyx surged 45% to $1.77 in recent Thursday morning trading, after spiking more than 50% before the market open. The stock saw at least one upgrade Thursday morning.
That upgrade came from Piper Sandler analyst Christopher Raymond, who raised his rating on Ardelyx to Overweight from Neutral. Raymond set a target price of $8, up from his previous target of $3.
"While we found the vote itself remarkable, more meaningful was the fact that the vote was not split along 'party lines,'" Raymond wrote. "Three nephrologists, three cardiologists and both biostatisticians on the panel voted in favor of the monotherapy benefit/risk."
Ardelyx shares were trading at $1.94 before the market opened on Thursday, up from its previous closing price of $1.22. Trading was suspended much, if not all, of the day on Wednesday.
Shares had traded in the $7 to $8 range until July of last year, when the FDA unexpectedly rejected Ardelyx's application for tenapanor's approval, sending the stock down 74% in a single day. At the time, the agency told Ardelyx that while the drug did reduce serum phosphorus levels in the chronic kidney disease patients, the actual effect was "small and of unclear clinical significance."
The rejection took investors by surprise, and analysts suggested that the agency's position was unfair. Piper Sandler's Raymond wrote at the time that the FDA seemed to have "moved the goal posts" by raising questions about the clinical significance at the last minute, after the agency guided the design of Ardelyx's trial.
Ardelyx appealed the decision once and was rejected, but in April of this year, the company said a second appeal had resulted in the FDA agreeing to schedule an advisory committee meeting. The FDA's briefing documents, released on Monday, reiterated the FDA reviewers' questions about the drug's clinical benefit.
"The clinical significance of the magnitude of the treatment effect is unclear," the reviewers wrote in the briefing document. "While there is well established precedent for accepting serum phosphorus as a surrogate endpoint and basis for approval in this therapeutic area, there is no precedent for accepting treatment effects of the magnitude seen in this development program."
Expectations for a new outcome were low going into Thursday's meeting, and the advisors' overwhelming support for the drug's risk-benefit profile, in the face of the agency's skepticism, took analysts by surprise. A positive vote by the advisors, however, doesn't necessarily guarantee FDA approval.
"This is somewhat uncharted territory as it's rare for an appeal to be granted an [advisory committee hearing]; even more rare for the [advisory committee] to resoundingly reject FDA's rationale," Piper Sandler's Raymond wrote.
Now, the FDA's Office of New Drugs, the entity to which Ardelyx had submitted its second appeal, will make a decision within 30 days on that appeal. If the office finds in Ardelyx's favor, the company would then need to resubmit its application for approval of tenapanor. Raymond wrote that he expected approval of the drug in the new indication at the end of next year.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
(END) Dow Jones Newswires
$weet RUN !!!!!
Institutions hold less than 1% shares. Along with dilution, why even buy now? Company needs to uplist to Nasdaq . The dilution will drive share price lower.
It doesn't matter! Diluting $250, 000, 000.
SEC S-1 > Ongoing shelf placement > $250M > " This prospectus is part of a registration statement that we filed with the Securities and Exchange Commission (the “SEC”), using a “shelf” registration process. Under this shelf registration process, we may sell any combination of the securities described in this prospectus in one or more offerings up to a total dollar amount of $250,000,000. This prospectus provides you with a general description of the securities we may offer. Each time we sell securities, we will provide a prospectus supplement that will contain specific information about the securities being offered and the terms of that offering. The prospectus supplement may also add to, update or change information contained in this prospectus.
Aaron Judge will pay 55% tax > NY city, state, & Fed. taxes. Steinbrener will need more than NWBO shares.
SEC S-1 > Ongoing shelf placement > $250M > " This prospectus is part of a registration statement that we filed with the Securities and Exchange Commission (the “SEC”), using a “shelf” registration process. Under this shelf registration process, we may sell any combination of the securities described in this prospectus in one or more offerings up to a total dollar amount of $250,000,000. This prospectus provides you with a general description of the securities we may offer. Each time we sell securities, we will provide a prospectus supplement that will contain specific information about the securities being offered and the terms of that offering. The prospectus supplement may also add to, update or change information contained in this prospectus.
"The Company believes this is the first time in nearly 20 years that a Phase III trial of a systemic treatment has shown such survival extension in newly diagnosed glioblastoma, and the first time in nearly 30 years that a Phase III trial of any type of treatment has shown such survival extension in recurrent glioblastoma."
BOOM > $$$$$
Yup, all good catalysts!
The racking up of ongoing corporate revenues taking TPTW to the Nasdaq Exchange next year.
Our acquisition of IST is huge > Revenues + >>>>> "has been awarded its third 3-year contract renewal valued at $2,862,435.00 with the U.S. Army Contracting Command, Stryker Division. Information Systems Technology (IST) will support the Initial Fielding of Stryker vehicles, Army Training and Education. The company will also create, maintain and track all logistical programmatic-related issues about the fielding, deployment, retrofitting, and prep for reset/reissue of Stryker vehicles."
"TPT Global Tech has been planning to enter the government contracting space for some time now as part of our overall strategic plan. This is the first of a planned series of federal contracts the company is expecting."
Agree!
News> PARSIPPANY, N.J.--(BUSINESS WIRE)--IVERIC bio, Inc. (Nasdaq: ISEE) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for avacincaptad pegol (ACP, also known as Zimura®), a novel investigational complement C5 inhibitor for the treatment of geographic atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). To date, ACP is the first and only investigational therapy to receive Breakthrough Therapy designation status for this indication, which was granted based on the 12-month pre-specified primary endpoint data in the GATHER1 and GATHER2 pivotal clinical trials.
“In both GATHER1 and GATHER2, avacincaptad pegol consistently showed a treatment effect with the first measurement at month 6 that was persistent and continued to increase over time, with observed efficacy rates of up to 35%”
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Breakthrough Therapy designation is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to show preliminary clinical evidence that the drug may demonstrate substantial improvement in effectiveness or safety over available therapies on a clinically significant endpoint and in general, should show a clear advantage.1
“We believe this Breakthrough designation reflects the fact that both GATHER1 and GATHER2 met their primary endpoint with a safety profile that meets the stringent criteria required,” said Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. “We are now focused on the execution of our full NDA submission and launch preparation, with the possibility of being first to market. We look forward to working collaboratively with the FDA to expedite the review timeline for avacincaptad pegol and to potentially bringing a new therapy to AMD patients impacted by GA.”
Recently, Iveric Bio announced the submission of the first part of its New Drug Application (NDA) for rolling review, which included the full clinical data package from the GATHER1 and GATHER2 pivotal trials. The company is on track to complete the final part of the NDA submission by the end of this year.
“In both GATHER1 and GATHER2, avacincaptad pegol consistently showed a treatment effect with the first measurement at month 6 that was persistent and continued to increase over time, with observed efficacy rates of up to 35%,” said Pravin U. Dugel, MD, President of Iveric Bio. “We believe ACP has the potential to safely and effectively preserve central vision by saving photoreceptor cells for patients living with this life-changing disease that leads to irreversible blindness.”
The FDA’s Breakthrough Therapy designation decision was based on the 12-month primary efficacy endpoint data from the GATHER1 and GATHER2 pivotal studies which evaluated the safety and efficacy of ACP in patients with GA located inside and/or outside of the clinical fovea. Per the special protocol assessment (SPA) agreement for GATHER2, the FDA required the mean rate of growth (slope) in GA area from baseline to month 12. These results showed a significant treatment difference of 35% (p=0.0050; GATHER1) and 18% (p= 0.0039, GATHER2) compared to sham using observed (non-transformed) data; and 28% (p=0.0063; GATHER1) and 14% (p= 0.0064; GATHER2) using square root transformation. In both GATHER1 and GATHER2 there were no events of serious intraocular inflammation, vasculitis, or endophthalmitis.
About Geographic Atrophy
Age-related macular degeneration (AMD) is the major cause of moderate and severe loss of central vision in aging adults, affecting both eyes in the majority of patients. The macula is a small area in the central portion of the retina responsible for central vision. As AMD progresses, the loss of retinal cells and the underlying blood vessels in the macula results in marked thinning and/or atrophy of retinal tissue. Geographic atrophy, the advanced stage of AMD, leads to further irreversible loss of vision in these patients. There are currently no U.S. FDA or European Medicines Agency (EMA) approved treatment options available for patients with geographic atrophy secondary to AMD.
Yup, definitely a great $$$$$ opportunity.
Let's go TPTW !!!!!
We're getting new long haul investors each day. > $$$$$
Also, the quality and quanity of government revenues generated from recent Multi-million $$$$$ contracts is sending TPTW shares much higher.
Soon we hit $1.00 > MICT is a great $$$$$ opportunity.
Another $tellar close. Patience pays off, especially with exponential revenue generation. Keep those nice Multi-million $$$$$ contracts coming!
TPTW
Let's go TPTW !!!!! > Another 80% + day today!
A book is baring all on Joe Biden’s love for stripping down in the pool.
In “The First Family Detail: Secret Service Agents Reveal Hidden Lives of the Presidents,” written by former Wall Street Journal reporter Ronald Kessler, readers get a look inside the private lives of politicians, told by the Secret Service agents assigned to protect them.
“Agents say that, whether at the vice president’s residence or at his home in Delaware, Biden has a habit of swimming in his pool nude,” Kessler wrote, according to the New York Daily News.
Female Secret Service agents found his skinny dipping to be “offensive.”
This is Kessler’s 20th non-fiction book. For “The First Family Detail” Kessler interviewed unnamed Secret Service agents about their experiences with some of the nation’s most powerful people.
“The First Family Detail” describes the vice president’s desire to be seen as a “regular Joe,” but says that agents find that “being assigned to his detail is considered the second worst assignment in the Secret Service.”
FILED UNDER: JOE BIDEN, JOE BIDEN 2020, BOOKS, JOURNALISM, SECRET SERVICE
POLITICO.