timberwolf7
7 hours ago
Took an all day charting course many years ago put on by Investors Business Daily.
Learned a lot, but the one thing that bothered me about their approach was, while they
selected 'quality' companies based on what they had to see to consider trading a companys stock.
Their approach was to wait until the stock had come up off its lows and clear the price point that was,
when the consolidation phase commenced. The interesting part was, some pullbacks are good for 10-20%
from this price. And as I watched/studied, I was left to ask, why would you 'wait' if you could capture some of this
pullback. And if the breakout failed to clear that price point, you could sell out with something vs nothing at all..
So I did something to see if I could capture some of this 'lift off'..
So do I wait for a peak to confirm? And a perfect 'low' to buy off of? Naw, Burt Baruch said it best, 'made my fortune by
not buying at the lows, nor selling at the peak'.. and it works.. question is, does your charting approach get ya 'close' to
at least the lows.. agree, the peaks are much harder to see coming..
timberwolf7
22 hours ago
HomerRomer
there is always the issue of, was the TRIAL and its design
robust enough to be accepted by the FDA.
I had ATNM that I had followed for several years, traded it
along the way as it gave. They passed their PH 3 with flying
colors and their development REALLY HELPED people dealing
with a type of cancer. REALLY HELPED.
They went to the fda, who obviously was consulted in the design
of the trial, the endpoints, with an NDA.
The only good thing was, I had not loaded up on shares because
there was a delay in the fdas acceptance of their submission (I had a
couple of thousand shares, but not as many as I planned to have for the
PDUFA date).
Turns out, the fda rejected the submission because the fda decided the
acceptance criteria the PH 3 met, wasn't good enough. Told ATNM
they had to rerun the trial and use new acceptance criteria.
My first reaction was, who in the hell wanted people to die, that instead of
saying, we will approve you cause you aren't hurting people, you are actually
helping people, but we want you to run a PH 4 with this as acceptance criteria.
So I am at the point, no matter how good things 'appear to be', don't rule out
a gov''t body surprising you at the last minute (for reasons)
HomerRomer
1 day ago
THIS IS WHAT IT IS ALL GOING TO COME DOWN TO:
You said:
Did Tonix Pharmaceuticals TNX-102 SL for Fibromyalgia meet primary endpoints?
ChatGPT said:
Yes, Tonix Pharmaceuticals' TNX-102 SL for fibromyalgia met its primary endpoints in two Phase 3 clinical trials:
Phase 3 RELIEF Study (Completed December 2020):
Primary Endpoint: Significant reduction in daily pain compared to placebo (p=0.010).
Key Secondary Endpoints: Improved sleep quality, reduced fatigue, and enhanced global symptomatic and functional recovery.
Safety Profile: Generally well-tolerated with adverse events comparable to prior studies.
SEC.GOV
Phase 3 RESILIENT Study (Completed December 2023):
Primary Endpoint: Significant reduction in daily pain compared to placebo (p=0.00005).
Key Secondary Endpoints: Statistically significant improvements in sleep quality, reduced fatigue, and better overall fibromyalgia symptoms and function.
Safety Profile: Well-tolerated with no new safety signals observed.
IR.TONIXPHARMA.COM
These results support the efficacy and safety of TNX-102 SL for fibromyalgia management.
If a drug in the Fast Track program has no safety concerns and has successfully met both primary endpoints in its clinical trials, the likelihood of FDA approval increases significantly. Here's why:
Meeting Primary Endpoints:
Achieving both primary endpoints is a crucial factor. Primary endpoints are the main goals set out in the clinical trial (e.g., efficacy, specific measures of health improvements). If both of these are met, it suggests the drug is effective for its intended use, which is a key requirement for approval.
No Safety Concerns:
The absence of safety issues is another major factor that plays in favor of approval. The FDA places a high emphasis on the safety profile of a drug, and if no serious adverse effects are observed, the likelihood of approval is much higher.
Fast Track Advantages:
Since the drug has already met its endpoints and has no safety concerns, it’s possible that the Fast Track program could lead to an expedited review process and an earlier approval decision. The FDA's additional guidance and quicker responses during Fast Track may help the drug maker address any remaining issues efficiently, allowing for a smoother approval process.
Probability of Approval:
While there’s still a final evaluation of the overall risk/benefit profile of the drug, having demonstrated efficacy and a solid safety profile puts the drug in a very favorable position.
Historically, drugs that have met both primary endpoints and shown no major safety concerns have a very high chance of approval. Approval odds can rise to 80-90% or higher in such cases, as long as there are no other issues (like manufacturing concerns or inadequate post-market surveillance plans).
In summary, if the drug in question has met both primary endpoints and has no safety concerns, it's in a strong position to receive FDA approval, especially when fast-tracked. While approval isn’t guaranteed, the probability is much higher compared to drugs that haven’t reached these milestones.
In October 2024, Tonix submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for TNX-102 SL. The FDA accepted the NDA in December 2024, with a decision on approval expected in 2025.
GLOBENEWSWIRE.COM
If approved, TNX-102 SL would be the first new drug treatment option for fibromyalgia patients in 15 years.
90%+ chance of approval within the next 6 months will result in MASSIVE stock appreciation! Huge market for the drug also. That all makes this stock very undervalued at a $65 million market cap!!
Dumb&dumber4long
1 day ago
1 billion shares prior to the split were authorized.
They spent/used 500 million of the 1 billion, that’s how the outstanding shares rose to 559 shares in Jan 25, right before the RS (which explains the action on tnxp).
This part is clear as daylight.
Then think about what you’re implying of the remaining number of shares. It implies 100,000,000,000 (100 billion on pre-split basis, since you’re keeping the same 1 billion basis.
The wording you highlighted in Red from the filing, it’s a fact, but subject to the RV.
Ask you broker, assuming the person you get is knowledgeable!
Ask your AI, like MSFT CoPilot
Dumb&dumber4long
2 days ago
No, far from it.
1st, about 500 million shares out of the 1 billion shares were already exercised, I mean they were part of the outstanding shares when the RS took effect.
2nd, as far as the remaining 500 million shares, the same RS apply to them, since the 1 billion shares were authorized prior to the split, meaning at most another 5 million share can be released, added to outstanding shares.
You’re right, what was authorized can’t be changed, unless another filing is issued to do so.
The 1 billion shares wording can’t be changed, but the remaining shares are subject to the RS.
How did you come up with 994 million shares, when 500 million shares were subject to the RS, they were outstanding prior to the RS.
timberwolf7
2 days ago
Effect of the R/split on authorized shares:
Pretty sure what this is saying is, the number of AUTHORIZED will remain
at 1 Billion, while the outstanding gets the 1-100 reduction. No?
Meaning they can now sell up to 994 Million shares at the ATM or offer
them as pension, or....
To close, I agree with you, with regard to the 1-100 should have been applied to the
authorized, but thats not what I am reading and why I made the comment in the
first place..
From page 3 of the filing on 2/3/2025:
Capitalization. The number of authorized shares of Common Stock was and will remain
at 1,000,000,000 following the Reverse Stock Split.
As of January 31, 2025 there were 559,044,486 shares of Common Stock outstanding.
As a result of the Reverse Stock Split, there will be approximately 5,590,445 shares of Common Stock
outstanding (subject to adjustment due to the effect of rounding fractional shares into whole shares).
The Reverse Stock Split will not have any effect on number of authorized
shares of Common Stock or the stated par value of the Common Stock.
timberwolf7
2 days ago
My take on the 'authorized' shares vs share count:
=its an ATM to be used as they determine 'necessary'
=it allows for usage of shares as needed for 'compensation' purposes
Agree, 5.6 Million shares at the moment, that heavy sale to get to this number
is why I cut my target price to a 1/3rd of what I originally had (now around $80/sh vs $300)
And I suspect if they had their act together, they unleashed some more with the share price at $20.
They would have been foolish not to.
So no idea where the share count is at now, but wouldn't be surprised if my target price is now down to $70
and I don't know it.
The 'good news' is, given my cost basis, I will do quite well if it reaches $70. But yeah, have made my last ad
till I see the share price starting to roll up.
Note: TNXP and another one is the first time I have seen a r/split NOT reduce the shares authorized number as well.
That is a bit disconcerting.. And not used to seeing numbers like 400,000,000 million AUTHORIZED shares either.
Tho do understand, the companys interest is in their own survival, and ours is to hope to ride their efforts to some success.
So anyone believing a company is putting shareholder interests into consideration, needs to understand, its the BIG
shareholders they are careful not antagonize, not us retailers..
Dumb&dumber4long
3 days ago
Shorts & everyone else,
Not looking for speculative answers/opinions,
Looking for fact supported response.
My Plan to buy more shares is on hold for now, why?
Last year Tonix filed notice to issue up to 1 billion more shares.
It had about 24 million shares outstanding in 2024.
Increased to 186.6 million shares in 2024.
In January 2025 the number of outstanding shares increased to 559 million shares.
Then came the 1 - to - 100 RS, (559/100=5.59 million shares outstanding)
The Q is why didn’t Tonix issue the authorized 1 billion shares?
Does this mean that Tonix has the ability to issue the remaining number of shares at Will, to raise cash!
Or was most of the remaining shares kept for top employees (executive level) options Plan!
If the former proven to be true, Tonix can flood the market with about 500 million shares!
Looking for factual input.
timberwolf7
4 days ago
Yep, TNXPs chart 'trends' were wrecked with the r/split news, the
driving down of the share price.
Now the chart is going thru a hard reset as shareholders make their
choices on what they do next. And its going to take 'some' (undefined
cause shakeouts can be quick or long) time to put in a bottom and
the company to reaffirm why folks should want their shares going
forward.
But like the chart this morn. The sentiment indicator I use is showing
bigger 'buy' orders are dominating big sell side orders. IE, whats that saying,
when a stocks price crashes, its the smaller retailers that do the selling at the lows
while the smart money does the scooping up of the cheap offerings.
And again, this is with the biosector under pressure (IBB, XBI, LABU)
timberwolf7
4 days ago
BIO SECTOR has been under pressure since the election.
No surprise why either cause it could use a good 'housecleaning'.
Unfortunately, while a few of the big boys like pfe deserve to be
nailed to the proverbial barn wall for what they have done?
Its going to cause some collateral damage to many others.
Check out IBB, XBI, LABU charts. Yep, until a company is
strong enough to stand on its own merits? Expect to see
them get jerked around.
That said, investing for me is similar to the fable about
the TORTISE and the HARE. Just have to hope ya
bought into a good turtle that has staying power no
matter what happens along the way to at least give you
some degree of a 'win'..
timberwolf7
5 days ago
Frankenstin: was just coming on to mention
that the VOLUME last FRIDAY was significant.
And was wondering over the weekend IF that big
volume spike meant a 'turning' point took place last Friday.
Aka, you look at charts long enough, and at the peak highs
and lows, its not uncommon to see a 'surge' in volume indicating
a change in sentiment/the trend just took place.
at the peak highs, they call it a 'climax' topping where the 'excitement'
just ended. Sellers dumped shares to those the masses that are showing up
hoping the party is just getting started.
And on the opposite end? Sort of the same thing. Those late to the 'shorting'
cutting my losses gang give it one last go at shorting and dumping their shares,
while those sitting on gains from shorting, and those that see the shares as cheap,
decide its time to call it a day and buy cheap what the late to arrive are 'offering'..
Don't know, but looking at Fridays volume, looking at how far they have taken the
share price/market cap down? Was watching this morn to see how much 'fire power'
was going to be thrown at trying to drop it some more.. How many were going to
be willing to commit to trying to get some more??
So far?? Like that I am seeing bigger vol minutes on the chart corresponding to blips
higher in the share price. Not saying it can't be walked down a bit more, but the ones
thinking about it, have to be wondering, when are the buyers going to step up because its gotten
pretty cheap... PS: a sentiment indicator I use, that turned slight positive Friday, is a bit stronger
to the positive side today..
But too early to call anything, see where they are come Friday.. need a few days for a 'trend' to
have some viability...
timberwolf7
1 week ago
Figured they would try to hit it and at 1325, the effort 'commenced'..
22,000+ followed a minute later by 56000 and they were able to drop it around
50 cents ($12.5 range) And they are trying to push it lower as i type, with small
volumes, like they are probing enemy lines to see how much 'resistance' they
are facing (got to love this stuff) But they have gotten it down 85 cents now to $12.14..
Ran flat since 1030, volume anemic as both sides appear to be waiting to
see if the shorts are done and the shorts likely wondering if they dare to
push it lower again..
Would really be nice if management had a surprise for the market wouldn't
it.. (smile)