I think this one is in Phase3
But they have to submit the package first.
That's where we are. I don't know what is left in their phase 3 trials.
Can you imagine the pure hell it must be to compile all that crap in a format the FDA wants?
It makes my head hurt thinking about it. There are Companies that do that. I'd love to know if these egg heads are doing that in-house or have outsourced to a third party?
That would be a good question for the Company. It would give a little more confidence.
The FDA will allow that kind of PR. Even all that shit is regulated and can give a new drug review a bump in the road. They have to be very careful what they put out.
But it's definitely getting exciting.
For the first drug yes. They posted positive phase 3 results. The anxiety or depression spray?
The stock will get a sweet run on the PR that they have submitted the entire package to the FDA for review.
That is close. It could come any week.,
It's why the stock has not pulled back more. All shareholders are holding. The float is being held tight.
And with Fuji coming in funding the Menopause thingy? Wow! That gives great confidence thst they will never need toxic funding from dilution.
You'd expect if it did tank, they would buy back shares too
I really wanted to see this crush below $4
I don't think that is possible now.
I wish I had a spare $12k to put in this.
I'm lucky to muster $1,200
I got too much mo ey tied up dead in other shells. Thanks Brandon for killing American confidence in going public. Killed my gravy train
So we are in the beginning of the end of the process I guess ?
It can be 5+ years from the start of the process from phase 1 to the end of phase 3 where they submitt their info. Once the FDA gets it....90 says or so. Every drug is different. Some get fast tracked. The FDA has a page where they publish the PDUFA date. That's their gestimation on their review findings. Once it gets close to that date and it hasn't been kicked back. It gets exciting. The FDA can be picky. I've seen drugs kicked back on wording. Stupid shit. Like they didn't use blue ink? Minor stuff like that happens fast in the review. We get over the first 45 days! Hello!
I'm not sure how the FDA is today after all the heat they are getting over the COVID vaxxx scam.
Rubber stamp what the shadow government wants destroyed their street cred fast.
It's one reason a New Drug patent should get a good 35years of Global protection. The shit they have to go through
Is it Usually a long wait for a 501?
Didn't VGTN get FDA fast track designation for one of its drugs in the pipeline several months ago?
I forget what they call it but a FDA 501 new drug approval to market and sell.
That's the king shit. Then MMs will kill the run and short the hell out of it. That will continue till a marketing or buy out PR happens.
We already have Fuji throwing money at them on todays product in phase 2
Wait till the FDA stamps it.
300-800% run is my prediction. It's not just one drug but a pipeline. They won't sell out. They are going to milk these 3 drugs with positive Q reports for the next 25+ years.
It would take one hell of a buy out to get these guys to give it up.
Positive news like this will keep the stock from falling. This could very well be the new bottom.
I'd buy this for my wife today. She keeps both A/Cs at 65degrees. All the dogs and me are on the front porch having coffee in the BAMA heat.
And getting out of the shower is fridgid hell
What would you say the big news in the pipe line is ?
Looking good for the second drug in the pipeline.
I guess no one died in phase 2. People tolerated it and they see positive outcomes.
News means they are having positive results or there would be no news.
As good as this news is, it's not the big one that will move the Market cap. Not yet. It's still in accumulation mode.
Vista Gen knows it's git a powerful pipeline.
This is what I look for as an excellent sign, this is going to be big.
Sales and marketing deals is cherry. Buts outs aren't bad, but why sell out when you know your sitting on 3 mega $B drugs.
Not sure, this has powerful potential. Like viagra type potential. But where Viagra is more psychological and you know if it works. Psychosomatic treatment are more determined by people's mental needs and state of mind. If you believe it helps, then it helps. You score a customer for life. A lot like wearing clothes that make you feel good. Its all mental. It's funny, my dad was a doctor fresh out of Tulane m/ Charity hospital. He saw his fair share of the crazies in the 50s. He was then sent to be a doctor for an entire county up North. He did everything, and saw everything. He was the only pharmacy too. The county loved him. He had these 3 different colored sugar pills he sold for anxiety and stress. Everyone started out with the yellow. If things got tense he'd upped the strength to the Blue. The green was left for real world stress. If it wasn't for those sugar piles he would have starved while working 150 hours a week aging in dog years. So we have that aspect going for us.
Take a look at TR&RI. Alzheimer's drug that can focus treatment meds to one particular spot instead of going all over the body. South Korea Bio, Low under 450K float. Explosively low float. .25-.45 cent stock. BID sitting is dead money. I think there are a few of us that like to paint it up for kicks and giggles. Spread is close to 100% most weeks. I've set a few ghost Bids and paint. It gets knocked back down where you really score your lotto tickets.I got my $5k in it, so I'm good. Waiting on news.
Set your limit BID buys and pray you get a load before they PR they have all paperwork submitted to the FDA.
Have your limit sells set for that. Don't get greedy.
After that run and pull back, get set up for the FDA approval PR. The FDA will publish a PDUFA date to give some sense of how much time we have to load.
Same thing will happen on FDA approval. A great run to be killed by shorts. Cash in.
It has to show it's going to sell or get a buy out.
That's when it turns into a long term hold.
Agreed. Early Aug. was sweet, late Aug. bitter.
Gotta go after the low-hanging fruit, then book.
Yea I exited here a long time ago. You had to be so fast to catch the little rally
It's how these do after good news.
My first low alert is $3.99
I'll follow it down too.
Anyone know the PDUFA dates for the first spray? Best be in thick before.
I expect not to hear anything more till the FDA 501.
I got my Pharma perps looking at it too.
Pharma plays are always the target of MM short attack after good news. Even an FDA 501 approval.
You have to be fast on your feet till the drug is sold, bought out or shows it's going to be a block buster $ maker.
Even after a 501 it still needs to show it has market potential.
I'd imagine this will get bought out by a Big Pharma before its gets too high. Depression is a $ maker.
No chance. HKD float was something like 300k. This is 11 million.
Yep. Turned into a flaming POS.
Hope it starts soon. Bleeding slowly into the 6’s today.
“Since June 30, 2023 and through August 10, 2023, the Company sold and settled an aggregate of 1,487,293 shares of common stock under its Sales Agreement with Jefferies and received gross cash proceeds of $16,893,700. Additional sales of 1,965,940 shares under the Sales Agreement are expected to settle on or before August 14, 2023, subject to customary settlement procedures, for expected gross cash proceeds of $15,172,023.”
They’ve increased the float by about 4 million in the last couple of weeks. Closer to 10 million now.
Looks like this will hang in this region or slowly bleed back to 5’s unless more stellar news is released.
Maxim Group Upgrades Vistagen Therapeutics to Buy, Announces $30 Price Target
7:09 pm ET August 7, 2023 (Benzinga) Print
Maxim Group analyst Jason McCarthy upgrades Vistagen Therapeutics (NASDAQ:VTGN) from Hold to Buy and announces $30 price target.
Latest Ratings for VTGN DateFirmActionFromTo
May 2021BairdInitiates Coverage OnOutperform Feb 2021JefferiesInitiates Coverage OnBuy Jan 2021William BlairUpgradesMarket PerformOutperform
View More Analyst Ratings for VTGN
View the Latest Analyst Ratings
Vistagen Announces Positive Top-Line Results from Phase 3
PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray in Social
First positive U.S. Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years
Statistically significant rapid-onset reduction in patient-reported Subjective Units of Distress Scale (SUDS) score compared to placebo in a public speaking challenge (primary endpoint, p=0.015)
Trial also met the secondary endpoint, demonstrating a statistically significant reduction in proportion of responders compared to placebo as measured by the Clinical Global Impressions Improvement (CGI-I) scale (secondary endpoint, p=0.033)
Fasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials of fasedienol in social anxiety disorder
Over 25 million Americans are living with social anxiety disorder1