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Mongersen, GED 0301, already had unanswered safety questions that appeared in earlier trials. For example, in the Phase 2 trial there were 7 serious adverse events that included a hospitalization and two cases of worsening Crohn's Disease. One reason for moving to Phase 3 was to see if the benefits outweighed safety concerns. The safety committee ruled that the risks outweighed its benefit. The bottom line, Mongersen had serious safety issues before Phase 3 even began. They did not suddenly appear in an expanded trial. http://www.nejm.org/doi/full/10.1056/NEJMoa1407250#t=article
Do you know of any safety issues that we should be aware of with any of the current drugs under review? I mean, other than the safety issues that were remediated through lower dosages or easily treated?
“Celgene's Crohn's disease drug just failed Phase 3 so they might be looking for a replacement in B-UP”
But they maybe more cautious to avoid same mistake of overpaying for drugs with success in P2.
The P3 failure is a cautionary note to all who tout no failures for IPIX - it can come anytime specially when they move to larger trials.
Calling 3 Phase 2 trials, across 3 separate drug platforms that are now finished, no failures, and waiting for top line data before considering a partnership offer, calling that a “Hail Mary” pass is about as misleading a post as possible without the post being an outright lie. As of the release of data showing efficacy, for each drug there is a 58% chance to succeed to completion of its progress to approval. That includes the risks of Phase 3. Taken together there will be a 98% chance of approval for just one.
Since you are using a football metaphor, if there was a 98% of completing a pass for touchdown every time Tom Brady threw a “Hail Mary”, he would have won every season’s playoff berth and every Super Bowl of his career, except for those seasons where he was out due to injury, of course.
DF used a grant to fund an earmarked Cellceutix (for profit) Phase 1 trial. That’s how it most commonly works.
Mayo is a nonprofit. Government grants for clinical studies mostly go to nonprofit clinical sites. Those grants going to for profits are mostly for preclinical discovery and development. IPIX has received earmarked grants that went to clinical sites, and one went to DF, which was why Leo could not claim it. The grant clearly stated it was for use in the Phase 1 Kevetrin trial. I posted the NCI document about 2 years ago when it was published.
Dang those don't even add up to 1mm in grants for ipix.
Then there's this grant for a phase 2 oncology trial.
https://tapimmune.com/2015/09/tapimmune-vaccine-to-be-studied-in-a-13-3-million-u-s-department-of-defense-grant-to-mayo-clinic-for-phase-ii-clinical-trial-in-triple-negative-breast-cancer/
Would be nice if ipix could get that $$.
For the record, I picked up a few thousand more shares yesterday. I recommend picking up what you can afford this week. Those looking for lower than .60 are flat wrong. I doubt it breaches .65. Any PR this week takes the price back to >.70.
But then my posts aren’t “rated pro.”
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=135455373
To repost from earlier today: "As of Sept 29, there were >1,214,000 shares short. At the current dollar volume that would be a month to cover, if it were possible to add 50,000 shares in buying pressure over 20 trading days.
At some point, short interest will be forced to cover. That could be in as few as 3 days if there is a gap up. The increases in misinformation, (attacks), and lies about IPIX speak volumes about that impending short crisis."
What nonsense. This PR reports the close of the trial and close of final data collection. This is clearly a PR announcing a milestone for a trial, as any other company with only one trial trial would do.
So, the CEO confirmed final data collection and the close of the trial? Can you point to where he said that in the previous PR? If I recall, he reported only the last patient.
The PR official stated the close of final data collection and announced that the top line data will be this quarter. That's news, not fluff.
As of Sept 29, there were >1,214,000 shares short. At the current dollar volume that would be a month to cover, if it were possible to add 50,000 shares in buying pressure over 20 trading days.
At some point, short interest will be forced to cover. That could be in as few as 3 days if there is a gap up. The increases in misinformation and lies about IPIX speak volumes about that impending short crisis.
For the record, I picked up a few thousand more shares yesterday. I recommend picking up what you can afford this week. Those looking for lower than .60 are flat wrong. I doubt it breaches .65. Any PR this week takes the price back to >.70.
But then my posts aren’t “rated pro.”
OK, I’m trying to figure out how anyone is clipping $1 million a week when that has been about the monthly dollar volume since August. Ah, I get it, all the volume has been a steady drip for months. No, wait, ...
*extreme sarcasm*
Drip Drip Drip IPIX lower. This has been an orchastrated walk down for months. The MM's, Aspire and Leo are basically plucking around a $1million /week from shareholders without them even knowing. They are doing it so without a panic collapse just an unrelenting chinese torture. hello low 60's by weeks end and 50's within 2 weeks
I want capitulation on Monday so I can buy more with cleared funds. Of course, capitulation might have been yesterday or come today. Story of my life, a day late and a dollar short. Would love to get some again in the .60s before this next huge run.
What nonsense. I’ve been here since before Leo took over. The price started its series of parabolic steps with a move up in July 2012 when it peaked at 1.90 range from a .60 start. It then entered a volatile but range bound trading pattern for the next 18 months. It then entered another parabolic stair-step beginning July-August 2014. Through all of that a pump group claiming to be looking for over $50 before selling kept adding participants. The group began liquidating CTIX at $4 and moving that money into CLSN which was supposed to be a lock on a FDA drug approval. Nearly the entire group took the money from their CTIX success put it into CLSN only to lose ninety cents on the dollar when CLSN failed its FDA approval. Yes, positive PRs of progression (announcing the Aspire deal started the run in 2012) were catalysts, but the pumping came from the $50 group. A rabbit participated only to lose huge. All those shareholders had planned to take their CLSN sure thing profits and reenter CTIX above $2, which of course never happened.
The main reason for the spike was that pump team. If one wasn’t here, one wouldn’t know that.
I don’t believe that for a second.
I have already donated to Leo's salary in the form of purchased shares from Aspire. I have more than done my part considering its impossible to sell the shares I already have
I agree. But I prefer to go with evidence based numbers to refute the 10% success myth that keeps getting posted. It’s 10% probability for approval only if one begins at Phase 1. Safety is the biggest barrier to successful trials and phase 1 focuses on safety. All IPIX drugs are now proven safe.
I really think that those 58% odds are an objective number...
But for IPIX, we have to be a bit more subjective...
B-OM already has interim analysis out....PLUS...Leo has stated if OM works, they are nearly certain UP would work...UP worked, so the logic implies OM will work. Safety has been established in the ABSSSI trials...this adds up to > 58% odds for B-OM
K was a 1b, and has had an observable effect on OV cancer cells, which have the highest percentage of P53 damage... and they are targeting OV cancer in the phase 2 trial. K was safe enough that MAD was declared as MTD.
P has already completed a phase 2a and is a pro-drug of an existing approved drug.
We have 4 shots at a 58% chance of success for Phase 2 trails. Of those that meet outcomes, there are then 85% chance of success for each in phase 3 trials, including ABSSSI once that trial starts. The odds are truly ever inour favor.
Didn’t they use the shelf once already for a private placement? Half at that time would have meant under .50. Didn’t happen. Complete nonsense.
When a person uses another’s numbers, those numbers become that person’s numbers.
What a complete fabrication. Kevetrin met all its outcomes, primary and secondary, including efficacy. Efficacy for Kevetrin is modulating and possibly repairing p53.
Absolutely incorrect numbers. Phase 2 drugs have a 17% chance of success through approval. After successful completion of Phase 2, the odds jump to 58%. Both B-UP and B-OM are considered topical drugs that only have to demonstrate very low or no absorption to remain in the topical category. Topical drugs fall under less stringent requirements than internal medicines, which changes those odds to a much higher likelihood of approval due to lowered FDA requirements for that category.
According to a study published in Nature, the success rate overall is less than 10%. But the success rate for each following stage significantly increases from 1 to 2, 2 to 3, and 3 to approval.
“They found that the probability of success was 63% in Phase I trials, 31% in Phase II trials, 58% in Phase III trials and 85% during the regulatory review process, for an overall success rate of 9.6% (63% × 31% × 58% × 85% = 9.6%).” —Jun 30, 2016, Parsing clinical success rates: Nature Reviews Drug Discovery
So there is a 17% chance of success from the current phase 2 for each of OM, UP and P. Then each of these that successfully passes phase 2, plus ABSSSI, all individually have a 58% chance for approval.
If the call option is .70, you still lose 100% of the option purchase price, .70. If the option is for 2.50, then you need 3.20 plus fees to make any money. Anything lower is a loss. Anything below 2.50 plus fees is a 100% loss.
Well stated. I was reacting to the more general “option” statement.
As risky as an option. Options are a sweetener for large share purchases, taking on senior positions, among other things. Options often expire becoming worthless, among other things.
I don’t think Phase 3 can be skipped, though I hope the same. But, I do think B-OM will be licensed independently of the B platform since it is an oral rinse. That can easily come in the next quarter or two and for a very large upfront payment.
Huh? Its not 10s of millions of short and naked short shares. It’s a few million short and only 1 million FTDs. A 1/10 reverse split would take the SP to $7 with a peak of $10. Short traders would hit that as hard as they could and drive it back under $5, which would kick in investment restrictions on institutional buyers. And that would lead to a sellingcascade to $2, and further institutional holding restrictions. I’ve seen it too many times.
That’s because this is an investment stock and not a trading stock. You can’t expect an Egyptian mau kitten to act like that old tabby stray you found 12 years ago. Or, more to the point, you can’t expect a biopharma startup with 8 trials—6 in phase 2–to act like that piece of shit, high volume, trading stock that’s actually going to zero someday because they actually got nothing.
Of course you can’t sell a low volume stock at the ask, at least not without a lot of patience. Every experienced trader knows that. The ask is now getting hit. So, sell away.
I can't even sell 2000 shares at the ask.
The twice monthly FINRA report says There are uncovered shares (naked) which are listed as fail to deliver. It’s not conspiracy theory. It’s a fact that there are over 1 million uncovered IPIX shares
A reverse split is the best friend of covered short interest. Naked short interest is the one affected by the cusip change. If there is a temporary rally as naked short interest covers going into an uplisting, once on the new exchange short interest waits out the rally and has a much higher SP to work with as well as availability of shares to borrow at lower interest rates. It’s those two conditions that make a R/S the best friend of shorting hedge funds and strategists. That peak rally point is also the reentry point for uncovered shorting that can include off-shore naked interest, the group represented by those twice monthly FINRA reports.
Yes, Leo did this right. IMO, had he left open the possibility of a r/s to uplist, short interest would have hit IPIX a lot harder to ensure the need for a reverse. Short interest in hold have sold short in even greater volume with the assurance that they could cover after >10/1 split.
i follow many biotechs and trust me when i say a r/s has not been the answer for IPIX. Leo has gotten this right. there's endless examples from many of the most very promising bio's. many of which are on major exchanges.
start up bio r/s on a major exchange is how wall street makes easy $$.
we're not alone in our fight - we just took a different path.
my money is on this company succeeding. we know who we are.
There seems to be some rather important misperceptions on this board regarding cancer trials. About placebos and according to the NCI (bolded text mine):
“Placebos are rarely used in cancer treatment clinical trials. They are used when there is no standard treatment. Or, they may be used in a clinical trial that compares standard treatment plus a placebo, with standard treatment plus a new treatment. ... You always will be told if the study uses a placebo.”
Standard treatment plus placebo and standard treatment plus new treatment means all patients are still receiving the standard treatment. Yes, the NCI and the FDA both consider treating cancer trial patients with only a placebo to be unethical and smething to be avoided.
No one should be in a "what the heck" over Kevetrin. The company has made it clear it is in a phase 2 trial to better understand its MoA.
There are no pros involved with ipix -- except aspire. The idea that pros are "working" ipix share price is fanciful.
Sometimes, but mostly they box the price to create predictable points to transition from long to short. Keep in mind, cash from a short sale is not taxed until covered and that cash immediately becomes available for trading and margin requirements. Boxing the price below .80 protects cash from short sales above .80. That cash above .80 adds to the buying/shorting power for the portfolio.
I’m just trying to figure out what part of “focused on partnerships and current trials” is hard to understand.
yes
many moons ago
not heard from since
The only way your comments are pro rated is if the targeted pros are seeking to box the price, as they have done so far in spite of tremendous trial progression.
All my comments are rated as pro so what you say is impossible
Because those aren’t duplicates,
That’s not at all, in any way whatsoever, what I said.
Glad to hear that you think Leo will close a UP deal any week.