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I'm pretty sure that is off. Wais cancelled I think 1.7 billion of those shares. I'd subtract that but add the 262 million given to JSJ for a final settlement.
Kevetrin Phase 2 Trial for OC:
Question to all doctors and knowledgeable folks about this trial.
This trial started sometime in February I believe. Atleast a PR went out on Feb 10th stating initiation of "main" clinical site.
I am at an understanding that the biopsy and testing with extremely expensive lab equipment are going to be used to help BP understand the MOA. My question comes in regards to the patient population. There are only about 5 patients per Cohort. And the dosing is only 3 weeks, 3 times per week with a 3 week follow-up. Are these patients very hard to come by? For example, at Dana Farber the phase 1 wanted all different kinds of cancer patients and they had to be stage 4 I believe. In this phase 2, there is no mention of what stage the patient is in. I am not familiar with cancer types or stages but I do know per the Clinicaltrials.gov site it says:
The patient population recruited into this study includes those ovarian cancer patients that have platinum resistant/refractory disease, defined as disease progression/relapse within 6 months following the last administered dose of platinum therapy (resistant), or lack of response or disease progression while receiving the most recent platinum based therapy (refractory), respectively. Patients may or may not have had additional treatment (e.g., Doxil) prior to entry in this study
Great DD. All new investors! Start here
There is a closing ceremony ish to the conference. There will also be an award for best poster at that time it appears. So maybe many peeps come back towards the end to see who won? Lol
Either way who cares. We have CDAs already in place. This conference gives mgmt time to network and have closed door meetings.
Listen to the last corp call. It was an amazing story about the conference they attended last minute in Florida. They didn't even present or have a poster if I'm correct. They simply went to have meetings and quickly gathered some of the worlds best IBD doctors, paid them a lot of money for a short meeting and here we are!!!! We would have never been here about to present UP data if it was not for that meeting.
However, I don't remember a peep about that show prior to that CC.
Long story short - there is a TON of things going on behind the scenes daily that none of us know.
Let's just hope for 50% remission stats next week.
Image of preclinical Prurisol results
AMAZING
http://slideplayer.com/slide/219787/1/images/14/Prurisol+for+Psoriasis.jpg
That is pretty high. And would set the market on fire. I'm hoping for 40% or even 30% with a much quicker uptick on efficacy. Safer and acts quicker and equals Otezla efficacy. That is a winner. The BAR IS SET: 16 weeks PASI 75 - 30%. What will P do?
HUGE! And helps support an idea of straight buyout/sale of P. No strings attached. Let's get your 10 Billion Georgey. 10*6.25= 62.50 for starters.
;) plus b and K = triple digit share price if we get your value. IMO.
Could this happen by early 2018? I have seen crazier
I'll ride this wave!
SPenbenz: Dream scenario to become reality!
For this example lets assume a couple things. 1) MGMT decide to play this out and become a powerhouse bio tech company like REGENERON. So no full buyout, all partnerships/collaborations Also, 2) all trials are successful.
Currently we sit at about 130+ million OS with a share price of .92
Each Billion added to the market cap can equal about 6.25 in share price fully diluted.
Lets start with Prurisol for psoriasis. We know the numbers Otezla makes, approx 2billion a year. Now lets assume Prurisol blows Otezla out of the water and takes the number 1 spot in market for Moderate to Severe Psoriasis for ORAL: Lets then assume Prurisol at higher doses actually does wonders for Mild - Moderate as well!@ WOW now we see major cash. SO lets say we get a deal upfront for several hundred million, and milestones to approval for just Moderate to Severe for a couple billion and then double digit royalties. We would be looking at a share price above 20 at that point. Add RA and other AutoImmune diseases and the price goes up. More partnering and milestones on additional indications and the price goes up and up and up!
We would be currently sitting on the Nasdaq at this point with major institutional buying. Price would go up and up and up based on the big boys adding 10-20% per year on holding.
With this cash in hand we may even see Leo do some nice buy backs and possibly even start a dividend once we have market approval and sales are flowing.
Now move to B. Lets assume that B-OM uses the Fast Track designation and applies for BREAKTHROUGH and the numbers for "prevention" of server OM is like that of the first 19 patients. This could be on the market first??? But maybe not because of the type of patients needed for OM and Prurisol is using the 505 b(2) which would mean a smaller phase 3 so it's a coin toss IMO.
Either way - a deal for B-OM could be quick and sales in the 100's of millions per year would be my guess. Just for B-OM
The IBD program for B is the money maker IMO. We could see some major deals come through and as the formulation gets stronger there could be major milestones from this aspect on new formulations. We currently reside on the Nasdaq and have big institutions holding now about 50% of IPIX shares and many milestones to look forward to and what seems to be endless news, pumping the share price and value of IPIX. I think Crohns and pill formulation could be in the mix at this point in late phases, and will just add to the hysteria!!!
ABSSSI could be done by this point and approved and would also now be taking in a GOOD chunk of change for resistant forms of MRSA etc...
B for dermatology is now in full spin and mid to late phases giving the stock major bumps in value as this is a blockbuster role it could play. UP and UP and UP we go..............
J&J may put in a huge investment for topical treatment of devices for the antibiotic use at this point since B was already approved for ABSSSI by now. Big money.
The lab continues to turn here and eye and ear infections are on tap, Diabetic ulcers etc... All creating positive PR and adding to the potential value. The billions and billions are adding to the market cap at this point.
Now we get to Kevetrin. I firmly believe this will be the most valuable drug in our pipeline. It will be combo'd in ORAL form with EVERY single cancer that has p53 mutations. That is over 50% of all cancers. That is almost not fathomable. It really is. Especially with combo therapies. I can't even think of a price tag. But either way trials are needed on every combo and this in turn with CHURN out PR after PR showing better results with K and this in turn with add to the BILLIONS and BILLIONS on the market cap.
I wish I was younger and had more money to throw in this if they decided to go this route. Because I believe we would see 300-400 + + + shareprices over the next 5-10-15 years. Maybe sooner, but if they go about this in partner mode there will always be trials and always be approvals for these 3 simple drugs for years and years to come.
And then we have I think 15 more compounds in the chest to explore?>???? Lol
Love it !!! Great weeks/months/years ahead!
That's a real interesting perspective. I actually agree. When the first collaboration or sale of a compound takes place and IPIX is awarded 100's of millions if not billions, I think the rubber band effect will take place. It's just getting that monkey off the back first! IMO. And then it's go time. Especially after we uplist and start getting coverage and estimates by the big boys.
It's a curse IPIX has so many blockbuster drugs I tell you ;). Lol. Jk
Agree. A real "healthy" percentage owned by the big boys is what keeps the share price steady and sucks up much of the float. Imagine if only 30% is sucked up by big pharm and major funds/capital groups? That would be about 39-40million shares locked down for many years of future growth.
I would assume with our pipeline it will be much higher though. Like REGN, they have almost 70% of 104 million held by the big boys. That's why you see a 500 share price.
I believe an uplist is HUGE!!! And will be HUGE for IPIX.
Great day so far. 200K plus in first 2 hours.
I see increased Revs. Most pinks have zero but a pipe dream. Much much different here boss.
I came onboard here because of David. He has much to lose. So he won't go down without a fight. IMO. That is always important...find someone trustworthy in an executive role.
Why would he move to California to roll up his sleeves with Txhd if it was a scam? He could have just stayed in DC Virginia area?
All in my opinion. This will bounce to new highs over the next year.
Not to mention adding Rajeev Varshneya as a Technical Advisor. That just doesn't happen to pos companies.
I do not agree. Those 200k plus Revs will turn into 300k plus Revs this quarter. We will see tremendous growth imo. I overheard of a 40 million per month client on board. No details tho.
Excellent. Let's take a 50 billion industry in 2018 (SMS) and soon to be 70 billion in 2020 and combine with Mary Jane industry of (legal in US) 6.7 billion in 2016 and projected to hit 24 billion by 2025
Ummmmm... huge POTential here.
Pictures are with a 1000 words:
http://slideplayer.com/slide/219787/1/images/14/Prurisol+for+Psoriasis.jpg
From pre-clinical work. IPIX's mgmt has been very confident that Prurisol could be a game changer, but they will not sound the horn until proof. I believe this phase 2b trial will be the proof and they will sound the horn.
I wonder if I was already signed up...do I need to again?
Great. Thank you for adding that.
Prurisol's Importance: data
We are nearing the very important and highly anticipated release of interim data for Prurisol for Moderate-Severe psoriasis. I wanted to put out an email with some very encouraging data and facts that I have been researching over the past several weeks. So hopefully this dribble is worth your time and can hopefully give you an appreciation for what is about to be released.
First, please understand that with regards to market; Psoriasis is currently about an 8 billion market and should be around 9 billion in the next year or two. (2019)
Chart.
Biologics (Injections) are the most effective, but also hold the most severe side effects and the largest chance to become resistant. I think it's like a 33% chance they will no longer work after a certain amount of time.
For IPIX - The current phase 2b POWERED study is using criteria that will give an APPLES to APPLES readout to Otezla. They are using the PASI scale in which Otezla (Celgene's Blockbuster) used. Otezla is the leading ORAL psoriasis drug expecting to do about 2 billion in revenues this year. I will compare mostly with this drug.
The Prurisol phase 2a used the IGA scale. This scale is basically 0 - 5 (0 = Clear, 1 = Almost Clear, 2 = Mild, 3 = Moderate, 4 = Severe, 5 = Very Severe)
The criteria was brutal, it was for MILD to MODERATE patients and the end result needed to show a GREATER THAN or EQUAL TO 2 point improvement. So for example, patients would need to have a 2 or 3 score and to end in a positive result the patient would need to go from 3 to 1 or 2 to 0. That is extreme. In PASI language that is basically saying they had a PASI 90 to PASI 100 score. The 50mg and 100mg arms in the Phase 2a did not show too much promise. But when the 200mg arm data was released this started to show some really good data.
To summarize:
Prurisol met the primary endpoint (2 pt reduction) in 35% of ALL patients who received a 200mg dose per day.
Even better, those patients that had a starting score of IGA 3 (MODERATE) who took 200mg met the 2pt reduction in 46% of patients. (VERY POSITIVE SINCE THE PHASE 2b IS FOR ALL MODERATE TO SEVERE AND AT MUCH HIGHER DOSES - 300mg and 400mg.)
NOTES - So we see that Moderate patients at 200mg had the best results. We don't know if it was a 2 or 3pt reduction, we just know they had ATLEAST 2pt reduction. Going from an IGA 3 to IGA 1 is in comparison to a PASI 90. So 46% had a PASI 90 in the moderate group. (Maybe not quite, but maybe)
In comparison: Otezla reaches PASI 75 around 30% and PASI 90 at 8%. And Otezla works around week 12-16. Prurisol starts showing improvements around week 4 and much larger psoriasis reduction around week 12.
OTEZLA DATA:
PRIMARY EFFICACY at 16weeks
1. PASI 75
- 33.1% Otezla vs 5.3% placebo
- 28.8% Otezla vs 5.8% placebo
MAJOR SECONDARY EFFICACY
2. sPGA (0 or 1 w/at least 2-pt drop from baseline)
- 21.7% Otezla vs 3.7% placebo
- 20.4% Otezla vs 4.4% placebo
OTHER EFFICACY
1. PASI 50
- Otezla 58.7% vs 17% placebo
- Otezla 55.5% vs 19.7% placebo
2. Achieved PASI 75 and sPGA 2-pt drop
- 20.3% Otezla vs 3.5% placebo
- 18.6% Otezla vs 4.4% placebo
Other factors: Otezla took 16 weeks to get to these numbers and only around 8% achieved PASI 90
I'm probably losing some of you, so basically Prurisol works faster and is more efficacious. Not to mention MUCH MUCH safer. Prurisol is part of an existing drug called Ziagen (HIV drug) so the safety profile is already proven and up to 600 mg. Due to this relation to Ziagen the FDA granted Prurisol a 505 2(b) meaning a much smaller phase 3 when the time comes and possibly only 1 phase 3 trial is needed and Prurisol could get 5 additional years of exclusivity (that equals BILLIONS more in revenues) We know that Prurisol is "dose dependent" meaning the more a patient receives the more efficacious it should be. Hence why 200mg worked way better than 50 and 100mg.
This powered phase 2b interim results will be data at week 6 for approximately 189 patients. We are now dosing at 300 and 400mg!!! So essentially we should see an even better read out of data. If this data shows a good % of PASI 75 at this 6 week juncture we could see a huge deal hit the wires. But I would assume Big Pharma wants the top line data which is set for late 2017. The 'primary' endpoint in this phase 2b is a PASI 75 readout. Like I said Otezla is ~30% PASI 75 - THAT IS THE BAR! If we top that we know we own the ORAL market. The kicker will be if we start to overlap into the Biologic's arena.
Here are some great charts for BIOLOGIC's
Chart
Chart
Here is an opinion on where the bidding price action could start for Prurisol if data is comparable with the phase 2A data and matches or betters Otezla:
As to valuation: (from IHub)
> If Prurisol matches (betters) Otezla (~30% PASI 75, 20% sPGA 0/1) and faster on the uptake // ~$3billion starting bid
> If we approach Biologics numbers (50% PASI 75 and ideally higher, with PASI 90s+; ~40-50% sPGA 0/1) // ~$5 billion starting bid
Just remember for every billion that IPIX can get if they decide to sell Prurisol outright, it equals to about $6.25 per share FULLY diluted. (this means options etc)
So lets put a scenario together if they sell Prurisol (the dark horse drug) outright.
5 Billion sale = $31.25 per share with just cash in the bank, but then on top of that IPIX still has Brilacidin and Kevetrin which are the most valuable compounds in the pipeline and are worth much more than Prurisol when the dust settles. Add that the buyout of Prurisol will put IPIX on the Nasdaq where we get new/more investors and institutional buying in which we have zero currently. Sky could be the limit in a very short period if things all play out well with data.
Have a great day and hopefully this helps you all understand how important this interim and top line data could mean to all of us.
Disclaimer: I am long IPIX. An OTCBB biotech company can often have an enormous disconnect in regards to share price and market potential. This normally will reset once a third party verification or collaboration is made.
Cheers,
FOR THE MOST RECENT CONFERENCE CALL (6/8/17) - http://www.investorcalendar.com/event/15776
It is. Here's my honest opinion. The way in which Leo was trying so hard to keep the share price up over the years drastically changed. I truly believe he knows what's coming. He is without a doubt keeping all shareholders in the know as much as he can, but the little PRs here and there have stopped. Especially with 4 trials ongoing...I'm sure he could reach in the bag and get more PR out, however......I truly believe a deal has been set. With ATLEAST a knowing that there is a set price and possible bidding if data is real good.
IPIX mgmt know what's coming. And they will let the data drive the bidding.
Aimo. Been here for 5 years and I can feel the confidence right now. I promise im just not saying that either....I can really feel it when I speak to them....it's almost like, "we know there is a huge disconnect between science and share price...but have a drink and relax, you'll be fine". They have done amazing things to get us here. Now we let the data take us home. IMO.
A 76K buy on the ask he meant
Probably a good idea. Lol. However Mr.W...Mr. Market has been severely disconnected in the past before on little biotechs and sometimes the re-evaluation wake-up calls bring true value and sometimes inflated values much much quicker than one can dream of. Hoping that will be the case here. I'm so excited for this P data. It could be our wake-up call
So say CTIX bags a 5 billion deal on P and still has K and B? I would assume the share price should be in the 40-60 area after uplist and institutional buying. Just my opinion. Maybe much higher? Who knows
1 billion equals about 6.25 give or take fully diluted. It was 6.37ish a while back. So I'm just guesstimating at this point.
Buying will commence heavily once we get data. I'm calling an uplift in 2017. And institutional buying will take this to new highs. I think we see some PASI 90 at a much higher percent than 8%
Otherwise keep buying. Get up to 500K shares if possible
Thank you! I'm marking this post to look back on. I think we can match and hopefully surpass Otezla. The market will wake up if so. Im
Patience Max. Day by day is not the way to look at biotech. We are waiting for data in the 3rd quarter.
These 4 data reveals will blow your mind
Ouch. Sorry to hear
Pharma companies we are in discussions with currently under CDA have only reinforced us that even a moderately effective psoriasis drug that is oral will have a very large market. Now if Prurisol can approach the efficacy of biologics, that would put Prurisol's valuation much higher. We'll have to wait and see what those results actually are.
Much higher valuations. I like that
Interesting view. It's hard for me as an investor to swallow 3 billion outright if we match Otezla. I must be greedy. But my 2 cents: the 505 could give an additional 3-5 years exclusivity. That in my mind at the end of already 10 plus years on patent equals billions. In addition there are other huge possibilities P can work on.
If Otezla is doing 2 billion and P MATCHES but also carries a better safety profile. Hmmmm. It's hard for me to say 3 billion.
Either way, good post and insight
Brilacidin franchise could be a Humira one day:
B-absssi : 1-2 billion
B-up/UC: ? BillionS
Crohn's: ?Bilions
Acne: ?
B-OM: 500 mil - 1 Billion
HP: ?
Eye:
Ear:
diabetic infection
Etc.......
Prurisol could step into biologic realm for psoriasis as an oral with safe history with ziagen
4 + billion a year
That includes other AI diseases.
Kevetrin: could have a part in 50% of all cancers. If they can achieve this as an oral formulation and THIS CURRENT trial shows promise in exactly what BP asked! Lights out price tag. So many billions I don't even know. 10? 20? 30? Billion a year? A pill that affects p53 wow.
I'm now seeing a 55-75 billion company. 300-450 pps
KarinCA: Anyway, three drugs in four trials for different indications will give us results this year. Some within a month and others in the last quarter.
Great quote. It's so simple when you read that. $$$$$$
Yes. The CC. I was hoping for something like "dosing" or "recruiting" but he just said "open". It was in the beginning intro to pipeline updates by Dr B
Thx for your opinion.
Here's a question: when Dr. B spoke briefly about K phase 2 Ovarian: he said the trial is "Open". Why not recruiting? Is there a difference in terms? My own personal timeline was for an update in July on cohort A so I'll wait until mid July before I reach out to the company for an update if we receive nothing!
I also believe that an investigation is ongoing. Every post is being documented, in a couple years there will be a 10,000 page report and most likely lock up everyone involved. Justice takes time. We know that Aschcroft is onboard, we know the FBI and SEC are onboard... So now they just sit back and watch and document and create a case.
All of that will not matter to us in the short term though. it will take time. We just watch the science move forward. No one can take that away.
In regards to a most likely dumb theory. I believe BP is behind this. From day one and their meetings with CTIX (now IPIX) they knew they wanted these drugs and they knew they were going to be extremely valuable. So I believe over the past two-three years since IPIX has not begged for a deal and has played the cool cat role, BP has wanted to make them as uncomfortable as possible. Cool and collective IPIX is moving forward with science and stats. Soon the "duel" will have to be resolved. Someone will have to make a move and I am betting it will have to be on BP's side...due to competition. That is what I believe. BP has billions upon billions to lose. I would not put it by them for hiring people under the table to make little biotechs squirm.
Leo and Dr. M don't squirm.
BOOM!
JMO
I agree - I am finding that everywhere I look. 600MG it is. :)
Abacavir (1592U89) {(-)-(1S, 4R)-4-[2-amino-6-(cyclopropylamino)-9H-purin-9-yl]-2-cyclopentene-1-methanol} is a 2'-deoxyguanosine analogue with potent activity against human immunodeficiency virus (HIV) type 1. To determine the metabolic profile, routes of elimination, and total recovery of abacavir and metabolites in humans, we undertook a phase I mass balance study in which six HIV-infected male volunteers ingested a single 600-mg oral dose of abacavir including 100 µCi of [14C]abacavir. The metabolic disposition of the drug was determined through analyses of whole-blood, plasma, urine, and stool samples, collected for a period of up to 10 days postdosing, and of cerebrospinal fluid (CSF), collected up to 6 h postdosing. The radioactivity from abacavir and its two major metabolites, a 5'-carboxylate (2269W93) and a 5'-glucuronide (361W94), accounted for the majority (92%) of radioactivity detected in plasma. Virtually all of the administered dose of radioactivity (99%) was recovered, with 83% eliminated in urine and 16% eliminated in feces. Of the 83% radioactivity dose eliminated in the urine, 36% was identified as 361W94, 30% was identified as 2269W93, and 1.2% was identified as abacavir; the remaining 15.8% was attributed to numerous trace metabolites, of which <1% of the administered radioactivity was 1144U88, a minor metabolite. The peak concentration of abacavir in CSF ranged from 0.6 to 1.4 µg/ml, which is 8 to 20 times the mean 50% inhibitory concentration for HIV clinical isolates in vitro (0.07 µg/ml). In conclusion, the main route of elimination for oral abacavir in humans is metabolism, with <2% of a dose recovered in urine as unchanged drug. The main route of metabolite excretion is renal, with 83% of a dose recovered in urine. Two major metabolites, the 5'-carboxylate and the 5'-glucuronide, were identified in urine and, combined, accounted for 66% of the dose. Abacavir showed significant penetration into CSF.
That 850mg safety was based on what I read here a while back. I'd like to confirm that Ziagen was dosed that high in their phase 1 trial. I'll look into that today and provide a link so we have accurate facts. Also, I'd like to find where it states Prurisol is dose dependent meaning more or more often the better. Just so we have the facts. Science will prevail!!!!!
Mine were deleted on SA as well. Lol
All of this will not matter soon. Stick to the science and drown out the noise.