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I read it. This was the same thing when the signed the last Aspire deal and the one before...its all the norm. Gives estimates "IF" and when the decide they need cash.
Bottom line ----- it was an update on total OS and total share structure. We are looking at 185 million fully diluted as of today.
So if we sell IPIX for 1 billion that would equal $5.40 about.
So every billion is about 5.40
11 billion buyout = 59.45. I think when all is said and done we are well above that. I'm here for the next decade or two though.
Okay. Do you realize that the last 30 million deal we did with Aspire over 2 years ago...we only used like 15 million of it. Or was it 3 years. I'm not around my stats but I know we did not use the full 30 over the years.
Too much can happen imo. To put that 30-39 million into the numbers. I'd suspect that we have a partner well before we use 5 million imo.
Where do you get new shares of 30 million? All I see is that total share fully diluted is 185.
Otezla:
RESULTS: More subjects receiving apremilast 20 mg BID achieved ≥ 75% reduction in Psoriasis Area and Severity Index (PASI-75) vs. placebo (24.4% vs. 10.3%; P = 0.023).
How much did Otezla make this year? Is it one of the only Oral Psoriasis drugs? Those numbers are pretty low....I think the data in Prurisol phase 2a warrant a move to phase 2b with a bar set like that......I'll bet: we can lift that bar bro
"Potentially Best In Class" - I have done the research on current OM drugs. I can confirm that even if we stick with interim data sets...and we have room to drop those numbers we will be BEST IN CLASS!
Some posters here feel that the 70% will only go higher though. If we see 80-90% prevention rates. I'd expect a deal to happen very quickly. Jimo
I'll be happy in the 65-75% prevention rate. With a 20_25% placebo. That 40-50% spread is very very promising.
If we get 80% prevention. GameOver for the majority of the folks here. PERIOD. 80% prevention with a clear PK report. We may see this on the market much sooner than some think. IMO.
I'm hoping prior to Thanksgiving. Could be Monday for all we know.
4 dollar run coming times 3 or 4 buddy. You can't stop the power of dominant drugs
BOOM! Thanks. I approve this message
By 30% :). Imo
Awesome- Thanks! I have discussed the weakness of Valvide in the past and the data. But after looking into where AGO13 is, I think we are a could lap ahead too.
Oragenics believes they can complete their phase 2 trial by the end of 2018.
Here is phase 1b:
In a phase 1B clinical trial in 25 cancer patients with OM, AG013 was safe and well tolerated. Data published in the journal Cancer showed a 35% reduction of the duration of ulcerative OM in the AG013-treated patients versus the placebo-treated patients. Furthermore, close to 30% of the patients treated with AG013 were full responders while all placebo-treated patients developed ulcerative OM.
https://www.oragenics.com/technology-pipeline/lbp/ag013
Here is the current criteria on CLINICALTRIALS.gov
https://clinicaltrials.gov/ct2/show/NCT03234465?term=AG013&recrs=ab&rank=1
It is different than B-OM. Our primary was much more defined as preventative. IMO
I think you are right about taking a HUGE backend royalty and lesson the load of upfront for B-OM.
Awesome stuff and it appears from all of my DD - that B-OM could take the market first!
Got a hedge interested in CT. Very interested. When this thing hits the big boards....Watch out.
Imo
I mean.....I hate to brag :). But I read these Qs like I'm back in college trying to pass for the 5th time on my parents dime....
The lingo to me is about alleviating doubt on past performance.
They believe they can
Let's roll. Data is needed first IMO. In the grand scheme!!! We have very little time to get ready for the ball! IMO.
This is interesting! IMO. Under note 2 going concern and liquidity. I think it was around page 7 or 8. This is much much different than previous Qs. Each Q seems to be different. One Q back Leo was taking about possibly having to take an upfront license fee for possibly much less than wanted because of current stage of dev. Now this one:
-----
Accordingly, the Company’s planned operations, including total budgeted expenditures of approximately $15 million for the next twelve months, raise doubt about its ability to continue as a going concern. The Company’s plans to alleviate the doubt of its ability to continue as a going concern primarily include controlling the timing and spending on its research and development programs and raising additional funds through equity financings from its common stock purchase agreement with Aspire Capital Fund, LLC, an Illinois limited liability company (“Aspire Capital”). The Company may consider other plans to fund operations including: (1) raising additional capital through debt financings or from other sources; (2) additional funding through new relationships to help fund future clinical trial costs (i.e. licensing and partnerships); (3) reducing spending on one or more research and development programs by discontinuing development; and/or (4) restructuring operations to change its overhead structure. The Company may issue securities, including shares of common stock, shares of preferred stock and stock purchase contracts through private placement transactions or registered public offerings, pursuant to its registration statement on Form S-3 filed with the SEC on September 11, 2017. The Company’s future liquidity needs, and ability to address those needs, will largely be determined by the success of its product candidates and key development and regulatory events and its decisions in the future.
The Company believes that the actions discussed above are probable of occurring and alleviating the substantial doubt raised by our historical operating results and satisfying our estimated liquidity needs twelve months from the issuance of the accompanying financial statements.
------
This last paragraph has a much better tone IMO. Obviously I'm a bull here....but if you go back and read the same section on the previous Q's I think you will agree.
Go look at the previous 5 years of trials and their data. I think BOM -----Will be the # 1 preventative drug to market. And the data can actually be much worse than our interim and we still will be the first to market PREVENTATIVE IMO.
A company just paid 108 million and gave up double digit royalties for an OM drug that only prevents SOM 55% of the time. That deal was done in September.
Uplist soon brother!!!!! No one can hold this down
B-OM. Huge market potential for a first in class prevention drug.
HUGE phase 2 results anytime now.
The party will begin and run for months as we then have K results, Breakthrough designation announcement and then P results!
Most likely a deal in between or an uplist.
Boom time boys
So we will prove it. I am pretty sure they have not failed a trial to date. Proof is there. And the longer BP waits the higher the price. I'm fine with that. Based on all the new faces here and all bring so negative and Leo haters...I'd say something is about to happen and big!
Data for OM is being crunched as we speak.
Boom time.....soooooon
Kevetrin blind side news soon imo.
Mark this post we get something that no one expects. In regards to Kevetrin. Aimo.
Great data will lead to BREAKTHROUGH designation. That will be yet another catalyst. I could foresee a deal prior to the new year for OM too. A lot of cash out there that needs a home prior to year end bookkeeping.
OM brother. No psoriasis. I'm leaning towards just talking about OM for the next weeks until the reveal. And then I'll move on to Kevetrin.
Here we go. The weeks about to start. Get ready...you're b-OM data should be out soon.
IMO -
Prevention of 84%
Placebo 30%
Big.
Changing the requirement for IGA 3,4,5 patients instead of 2,3 would make a difference. So again changing the patient population from mild/moderate TO moderate/severe could have an enormous change in results.
In phase 2a - Asking to take an IGA 2 patient to IGA 0 to meet criteria is extremely stringent. Your basically saying; come on Prurisol.....cure Psoriasis and lay a PASI 100.
Aimo
Edit: from the biotech showcase:
"Among patients with the severest form of psoriasis in study, those having a baseline IGA score of 3 (moderate), the primary endpoint was met in 46% of patients who received 200mg per day. These data were derived from analyses of all patients"
Again that is very promising. To go from 3 to 1 or even 0 is like PASI 90. I think Otezla was like 8% PASI 90
Have a great weekend all!!!
I'm looking at the data AGAIN. I think yours and others confusion comes with the fact this was for MILD to MODERATE using the IGA scale.
0-clear
1-almost clear
2-mild
3-moderate
Placebo rates for this population are much higher. MUCH MUCH MUCH higher.
When you start comparing other drugs, they tend to MODERATE to SEVERE and also use the PASI scale
For IGA that is
4-severe
5-very severe.
So one can conclude that the trial design IPIX chose for the phase 2a was extremely stringent. I think Dr B even made mention in a presentation just how difficult the criteria was. But they had full confidence they could leave that 2a trial with something to show to move to a POWERED phase 2b trial using the same and much weaker criteria that others have used.
We can agree that the data want overwhelming in any way for the phase 2a. However, the interesting part is the response in a dose dependent fashion and the fact that the more moderate the psoriasis the better the response.
So that leads me to HOPE, that bumping the dose from 200 to 300 and 400 in this next trial and testing a population that starts as a 3 and 4 and 5 could have exceptional results.
I think the data in phase 2a for ALL patients with IGA 3 TAKING THE 200 dose achieved the 2 pt or more reduction like 55%
Now to me...that is significant.
I was under the impression this phase 2b was to show an Apples to Apples comparison in the moderate to severe population.
Data in EARLY 2018 will clarify
How is this bad:
(200 mg group)
At Week 12: 42.8% subjects (ITT) [and 55.0% subjects (PP)] achieved “clear” (0) or “almost clear” (1) in IGA
I'm actually confused. People on this board say this is uninspiring? I'm open for discussion. Can we post Otezlas phase 2 data? Did they ever use the IGA scale for mild to moderate trials?
Can you explain again why the 200 arm data is not good from the phase 2a for Prurisol? Or maybe you can explain why the commentary noted from the patients is not good?
I won't hold my breathe
I hope you do. IMO the P trial was not a bad bet for being the riskiest drug in the arsenal.
And I know Dr. M really believes in this drug. And thankfully IPIX owns 100% of the drug unlike B where the UofPenn will receive royalties.
Good luck
Here is my faith! Pre clinical work:
http://slideplayer.com/slide/219787/1/images/14/Prurisol+for+Psoriasis.jpg
And then the fact the phase 2a produced results in the 200mg arm of achieving the primary endpoint of showing a GREATER THAN OR EQUAL TO a 2 point reduction using the IGA scale in 35% of patients.
And the percentage was greater if you filtered only MODERATE (IGA 3) patients. I think it was 46% or something. Moving from 3 to 1 or 0 is considered higher than a PASI 75. And the trial proved a dose dependency. So I'm expecting 300 and 400 to show even better data.
But again. Let's see the data early next year.
Marked this post. I'll respond in January. One of the trials was held down the block from me. I have 100% faith that Prurisol will trump 30% PASI 75. Not a doubt. I also have zero doubt that Prurisol will act faster than Otezla and also have less side effects. But again, I'll respond to this post with the data released in January.
Good luck, you'll need it.
Here is KarinCA's post last night! Phenomenal and 100% true. If people want facts....here you go. Great post by a wonderful shareholder.
Huh? The price is the same for every reason KarinCA pointed out to already.
If you want to stick with your guns...then fine. Increasing the share structure 48% over 5 years is not diluting. We have initiated 8 HUMAN CLINICAL TRIALS in those 5 years. The company sold shares for cash to pay for those trials. 5 have been completed and successful while we are now waiting on 3 to provide topline data anytime now.
Without increasing the shares by receiving cash....how could this company have done such a remarkable job moving the science forward and most likely having 3 indications ready for phase 3 trials. Remember the company has stated publicly they plan on partnering after phase 2. We now will have 3 chances of that in the next couple months.
There is no debt here. This is not polymedix.
So again... how would IPIX be where they are today without carefully selling shares for cash?
Please explain
The price tag would be in the 10's of BILLIONS IMO. For outright buy of B.
We need a partner not an outright sale. Shareholders would receive gains for years upon years with a partnership.
All this noise only means one thing!!! Some one or entity is scared....real scared! I suggest to all: do your own DD and read KarinCAs post from last night. That post was very informative and factual. Great post
Go do some DD on nutlins. Look up how long it took for research and how much money was spent.
Kevetrin will knock the rust off by the end of this quarter. IMO.
Everyone has been put to sleep by the trial speed and are not focused on the 3Xs a week high dosing. Just remember. Phase one we dosed some at 10mg m2 once a week. And tumors disappeared.
I'm fully behind the company
They are pulling out all stops this week Hound. We are getting really close buddy.
40 million to achieve all of this is very very very good. I'm not sure what planet you live on where this is not progress: also we went from like 8 or 9 drugs to 17ish in that time.
I mean come on man. You say you were in from 12 -15 and you question the progress. 5 successful clinical trials and 3 mid stage trials about to release data. I know companies that went over 200 million on one drug and reverse split and in the end the drug failed. Leo has played this brilliantly.
IPIX Clinical Trial Timelines
2012
1. Kevetrin (Phase 1)
2013
1. Kevetrin (Phase 1)
2014
1. Kevetrin (Phase 1)
2. Brilacidin-ABSSSI (Phase 2b)
3. Prurisol (Phase 1)
2015
1. Kevetrin (Phase 1)
2. Brilacidin-ABSSSI (Phase 2b, Successful)
3. Prurisol (Phase 1, Successful)
4. Brilacidin-OM (Phase 2)
5. Prurisol (Phase 2a)
2016
1. Kevetrin (Phase 1, Successful)
2. Brilacidin-ABSSSI (Phase 2b, Successful)
3. Prurisol (Phase 1, Successful)
4. Brilacidin-OM (Phase 2)
5. Prurisol (Phase 2a, Successful)
6. Brilacidin-UP (Phase 2 POC)
7. Prurisol (Phase 2b)
Plus we are sponsoring this weekends HS conference. There are only 4 sponsors including Abbvie
Maybe our name gets out there and we get a some buying on nonday
I'm very interested to see which way IPIX plays these upcoming results.
We know a year ago they were in discussions with BP. We know Leo said the meetings have escalated and we know they have a virtual data room. We also know several CDAs are signed.
Who will be our PARTNER?