GBA Presents: RADIO SAVANT-!

vanzandt said:
Iveric Bio Announces FDA Has Granted Breakthrough Therapy Designation for Avacincaptad Pegol for Geographic Atrophy


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.

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.”
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New all-time high
Nice run from $18
$29.31

Stoney... what do Millenials do in times of turmoil?
They stay home and eat cheap pizza that at least tastes better than DPZ's cheap pizza, they buy it with their AXP cards... and they use their SnapChat app.

PZZA $77,29
AXP $161.40
SNAP $11<----:wtf:

SPX 4123.... waiting for Jamie Dimon's latest weather forecast to take out VZ's (expired yesterday) upper level 4144 Fib.

4200 tomorrow?
Maybe. I told Jamie I needed a good round number as a base for my new Fib charts.

>>>What shall we call the new thread Stoney? :sneaky:

Edit:
I predict China is gonna take a chill-pill over the whole Taiwan issue.
They wouldn't have aired that little CGI invasion plan on state tv if they weren't.
Perfect bs bluff to scare everyone.
Xi may be smart... but he can't fool VZ.
He'll back off for now.

Up we go Stoney.
Lighten up on tech and buy the Russell.
RUT--> $1790
 
4200 tomorrow?
Maybe. I told Jamie I needed a good round number as a base for my new Fib charts.

>>>What shall we call the new thread Stoney? :sneaky:

THIS IS THE BIG QUESTION I'VE BEEN WRACKING MY BRAIN...

IN THE MEANTIME I HAVE TAKEN THE WHIP OF INTELLIGENCE OUT OF DRYDOCK.

I HAVE PURCHASED A LARGE & POWERFUL GENERATOR THAT WILL BEAM STOCK PIRATE RADIO FAR AND WIDE
 
I AGREE. BACK N FORTH HERE. SELLING FND.

THIS NAME VUZI I AM REALLY DISAPPOINTED WITH. THERE WAS A NEWS STORY THAT APPLE'S SMART GLASSES ARE STILL A FEW YEARS AWAY. BACK IN THE DAY ( 2 YEARS AGO) THAT WOULD OF SHOT VUZI UP 17% AT THE VERY LEAST!!!!! NO REACTION...

LETS GIVE THIS 1 MORE DAY-- IT SHOULD BE RUNNING.

VUZI Vuzix Corporation

$4.23 +0.19 (+4.70%)<----------o_O
 
Vuzix
· In stock
Vuzix M4000 | Smart Glasses with See ...
Vuzix
Vuzix Blade | Smart Glasses with ...
upload_2023-4-13_12-55-17.jpeg

upload_2023-4-13_12-55-17.jpeg
 
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