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Phase 2b was 16 weeks of duration..
400 patients..
By time frames of start to full enrollment it didn’t appear to take long to find
Clinical Participants..
as disease affects 2-4% of population
and isn’t completely debilitating, clinical participation appears to be robust..
When Phase 3 replicates results for treatment Naieve sufferers ..
should be a blockbuster
Yes but they contribute to the UNO Party of destruction and thuggery
So it’s OK
How long did phase 2 last?
What was the treatment cycle?
Well ..
For treatment Naieve patients
They saw results!
That is why we headed for Phase 3
Herpes isn’t
Heroes isn’t
Spell check sucks
Curios attacking two monster human health issues..
Godspeed
Fibromyalgia is estimated to affect 2–4% of the population.[20] Women are affected about twice as often as men.[4][20] Rates appear similar in different areas of the world and among different cultures
So ..
Now that I understand timing of stock offering..
$4 is pre release target..
Funny
Repackaging with market exclusivity..
In disease where our drug will be first treatment ..
And the ten years of drug development
are already done..
“who represent the vast majority of the FM patient community. “
The fda agrees.. and supporting development of phase 3 program..
IF this had been the announcement
EARLIeR!!!!!
Very exciting
Guess you missed this..
The Company believes the safety and efficacy results from its FORTRESS Phase 2b FM study support progression of IMC-1 to Phase 3 development for “new” patients, who represent the vast majority of the FM patient community.
Analysis of the Company’s recent FORTRESS Phase 2b FM study data revealed:
“New” FM patients treated with its novel FM development candidate, IMC-1 , who were recruited into FORTRESS via advertising, demonstrated statistically significant reductions in FM related pain, fatigue, anxiety and depressive symptoms and showed an overall improvement in their global health status.
treated patients demonstrated a statistically significant improvement on the primary pain reduction endpoint (p=0.03) at Week 14, as well as a statistically significant improvement in the key secondary PROMIS Fatigue assessment (p=0.006) and the Fibromyalgia Impact Questionnaire-Revised (FIQR) symptoms domain score (p=0.015).
IMC-1 was well-tolerated overall, with only 4.6% of IMC-1 treated patients dropping out due to adverse events, as compared with 8.1% of placebo treated patients. No adverse event category in the IMC-1 group exceeded a 4% rate with the exception of COVID-19 infection
Blah blah blah..
Biopharma gets data back and has to release it before they have chance to analyze it thoroughly..
The FDA has said the phase 2 was a success by granting direction for a Phase 3..
To go through blinded data and see a tremendous pattern of efficacy..
The. To realize the pattern is specific to Naieve Treatment sufferers is
Insanely Exciting!!!!!
Because.. it means our drug will be the
FIRST Treatment when our Phase 3 does well..
Very exciting..
Yes.. if can’t get mc higher to avoid dilution a partner would make sense
But it didn’t fail
It succeeded
Hence the phase 3..
But you know that
They have their phase 1 for 2nd drug
and phase 2 for 1st paid for.. they don’t incur major additional costs until they
start next clinical round..
they have time to promote their success and let the market greater evaluate the opportunity before raising capital again..
So wasn’t sure about the timing of $.50 raise..I didn’t look at date..
They were obviously looking at some responders thinking phase 3 and higher valuation was slam dunk..
Sadly although they were correct about success..they missed the lack of efficacy for those already being treated.
Do we go back to the $8 valuation with new fda support? With new drug perhaps rocking out phase 1 for long term covid?
Do they roll the bones again and wait for higher valuations?
BioPharm should always have two years of operational expaens in the bank..
They would have raised money last week when they traded 111,000 000…
At $1.40..
why didn’t they?
Because..
Because why?
Because we don’t understand the phase 2 data and how successfully it effecs treatment Naieve patients..
And what that means for market potential..
And how well their phase 1 open label safety and efficacy trial is going ..
Otherwise they absolutely would have pulled the trigger on equity raise..
They pretty much have green light..
10,000,000 share are the float..
A fair and decent number of trading shares.
Doesn’t explain 111,000,000 trading in one day…?
So.. how is this possible?
People have sold shares that don’t exist..
And people have bought shares that don’t exist..
They still own them
They still have sold them..
So what happens next?
Thurs we have shareholder meeting with finance update( usually company update as well)..
June we have phase 1 toxicology and efficacy update on drug 2..
Company came out at $.50 share..
So most shareholders Probabaly bought
Held and bought more once fda agreed to phase 3..
Short sellers probably saw % gain and thought easy money..
So here we are..
What is the value of phase 3 drug in humans? $200,000,000..is first stop..
$10 per share..what is the cost of 2 phase 3 Clinicals in humans? $20,000,000?
The company has to make a better case of the success they expect in treatment Naieve patients in phase 3 because of phase 2 outlier data! Otherwise the cost of capital while not outrageous will still be disappointingly dilutive at this price level.
It would be nice if one of the longer term shareholders explained in layman terms what the positive signal the company is focused upon…
There is no immediate fda risk..
Basically they have approved our phase 3.
They would have had to raise money at $160,000,000 million market cap .. so that was priced in to $160,000,000 valuation
Plus we have another drug about to report phase 1 safety / early efficacy signal in June..
And a good short run puts us in place to raise clinical capital cheap..
111,000,000 share trade In one day up to $1.40..
Shareholder meeting Thursday going to be sweet
Just back to MC from a little while ago it s a n
9 X
Look at Minerva .. it fell from $12 to $2
now back up to $5 on fda reversal..
so it may double from here ..
should double.. but the fda wasn’t definitive about reversal…
So still hard regulatory rug pull risk..
FDA has basically ok our phase 3 design..
Go Bach to $3 is triple the current share price..
the reality is.. company in better shape
By far than before phase 2 results announced.. yet we still below MC..
By A Aoth CDs
I keep trying to find a better multiple opp..
But at $20,000,000 market cap.. when it was just &160,000,000 market cap AND they were succesful..AND they have other Drug about to drop Phase 1 data..
Just can’t do it..
Last post today..
I think last weeks buyers at 1.40 are going to make a lot of money..
The trading pattern
does not show where stockholders
sold a ton of stock at $1.40 on the way down.. it is possible that shareholders averaged down at .50 ..
making average cost..
$6000 = 1000 shares
$6000 = 12,000 shares
13,000 shares at $12,000 equals
Around $.90 cost..
So it is possible that millions of shareholders cashed out above $1..
out of valuation disappointment..
But .. I think if they took a moment to think about what the FDA is saying by granting a phase 3 for only treatment Naieve Patients..
They would come to the conclusion that proper valuation RIGHT NOW should be north of $10 per share…They will join us before June..
I don’t understand the value of
VIRI Pharma line as I delve into CNS area .
AVXL , anvs ..Bivi ..Rvph..
But .. the market place valued Viri at $160,000,000 BEfORE Phase 3 ..
success of phase 2 presumably would have pushed the valuation well past $200,000,000 or why would you value Viri at $160,000,000 BEFORE ?
So to my logic the Value of VIRI should be well past $10 per share since the FDA agrees that VIRI had a successful Phase 2!
Also seems to me ..and I am
Not a medical background kind of guy..
BUT if you do a Phase 3 focused as a First Response for Treatment..
the other drugs really don’t work( why would they let you be first) and if succesful YOU will own the market…
So seems to me.. not only was Phase 2 succesful but a homerun..
And they have another drug with data expected in June( next month) which is in an open label study..
Open Label.. Open Information..
Should be an exciting 30 days..
I don’t think $1,40 was right level for market makers to create their short level with 111,000,000 share volume..
they went by percentage gain ..but I think
they misread the room on Valuation..
We shall see
One Post
Once a Day
Effn Right
Let’s Go
Let’s Roll
Let’s save some lives!
Thank God for God
This thing came straight down from 8..
There was no support / resistance on the way down.. straight into the cents..
Which means.. there is no broken / resistance level between here and 8
.. it’s just whatever trading dictates..
Wonder if insiders telling stories about
open trial? What do you think?
Prestigious… haha..
Precarious is my auto correct function..
Only 99,000,000 more to cover before June!
About 5,000,000 per each trading day..
That’s if no one else wants any.
FYI I have no idea how many share are short out there.. stock traded 111,000,000 shares one day last week I think..
June we see phase 1 and other data for long covid..
Should be a good romp..
Open label at precarious health clinic..
Open Label means some of the data has to already be in hand..
Run to the Son
This is not the chart 100,000,000 shares sold short want to see
Good..no reverse split..
They shouldn’t have to..
June Flowers about to bloom
Extension of??
Phase 3 was the goal at $8 per share..
Goal achieved at $.50…
Think we have some upside
They threw the kitchen sink at $.70 and the buyers didn’t flinch..
Maybe we see something before june
After lawsuits insider buying has been very minimal..
Think co policy is options..
B you funny..
What is going to happen is.. in early June prior to shareholder meeting
they will announce Phase 1 of longhaulers..
Based upon reaction of Naieve FM
To Viri other drug think we in good shape.
Think IF there is a signal( which I think there will be based upon Stock Volume)
Than Market Valuation will sky rocket through 100mm.. or more than $5 share..
If it doesn’t and market maker shorts are able to keep price down..
than you do the reverse split..
But not before June..
Because I think they already know the answer