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But those small trials were with guidance from those interested in the IT. So, it’s a little misleading to say the company is too reliant on trial designs requested from interested parties.
Bullshit. It’s the dime traders who are doing the destruction. .48 bottom to .62 top, the dime flippers can’t help themselves and overwhelm any building volume.
How do I remove that irritating scroller? I subscribe to WSJ, NYT and Wash Post. I don’t need the POS telling me the headlines for what I just read.
6 months to a year? Not if the deal is already worked out and they are only looking for data from trials. If so, it’s more than likely they will be finalizing before the end of the fiscal year, or shortly after.
Did you read yesterday’s PR and 8K carefully?
Pre-Commencement Communications in Tender Offers: Rules 13e-4(c), 14d-2(b), and 14d-9(a) each allow written communications with respect to a tender offer prior to the formal commencement of the tender offer.In corporate finance, a tender offer is a type of public takeover bid.
The tender offer is a public, open offer or invitation (usually announced in a newspaper advertisement) by a prospective acquirer to all stockholders of a publicly traded corporation (the target corporation) to tender their stock for sale at a specified price during a specified time, subject to the tendering of a minimum and maximum number of shares. In a tender offer, the bidder contacts shareholders directly; the directors of the company may or may not have endorsed the tender offer proposal.
Thanks for answering my question, whether that was your intention or not. This is what I understood, but did want it to come from LR. The simmering pot is beginning to come to a boil.
The regulations listed by Leo each come under the general items I listed. Some items are required, those categories under which each falls may be omitted:
“F. .....
If the registrant makes available to its stockholders or otherwise publishes, within the period prescribed for filing the report, a press release or other document or statement containing information meeting some or all of the requirements of this form, the information called for may be incorporated by reference to such published document or statement, in answer or partial answer to any item or items of this form, provided copies thereof are filed as an exhibit to the report on this form.
G. Use of this Form by Asset-Backed Issuers.
1. Reportable Events That May Be Omitted....”
That was one of my points, the PR only contained information that may be filed under an 8K, but is not required. Nothing fictional or creative about my statements. One purpose of filing an 8K is that unlike a PR, an 8K misstatement can’t be walked back later without a correction filing. A PR can be corrected with a simple, at the time we believed it to be true. It’s a bit like presidential misstatements to the press as opposed to the same misstatements under oath.
However, your unwarranted criticism did send me back to the filing one more time where I reread this:
“o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))”
Any idea of what ‘pre-commencement communication’ refers? I mean before the commencement of what? I realize that this is macro-level and not micro-level minutiae, but feel free to be creative in your interpretation, if an interpretation is needed.
An 8K filing basically is Leo making himself and the company responsible for its content, which would be the content of the PR. In a sense it legally codifies what was in the PR, and it also may imply that the added data may be a material event affecting company value and share price.
This 8K May come under either or both of the following items:
Item 2.02 Results of Operations and Financial Condition
Item 8.01 Other Events (The registrant can use this Item to report events that are not specifically called for by Form 8-K, that the registrant considers to be of importance to security holders.)
https://www.sec.gov/files/form8-k.pdf
Innovation Pharmaceuticals Phase 2 Oral Mucositis Trial Additional Data Show Brilacidin-OM Demonstrated A Significant Reduction in the Incidence of Severe Oral Mucositis in Patients with Head and Neck Cancer (HNC) Receiving Aggressive Chemotherapy Regimen
BEVERLY, MA – April 9, 2018 (GLOBE NEWSWIRE) Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report further data analysis from its successfully completed Phase 2 clinical trial of Brilacidin-OM (see NCT02324335) for the indication of decreasing the incidence of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation.
Brilacidin-OM Subgroup Analysis (by Chemotherapy Regimen)
Brilacidin-OM was more effective in decreasing the incidence of SOM in HNC patients receiving the more aggressive chemotherapy regimen—cisplatin administered in a higher concentration (80-100 mg/m2), every 21 days—as compared to lower concentrations of cisplatin (30-40 mg/m2) administered weekly.
For the Modified Intent-to-Treat (mITT) population, Brilacidin-OM in the aggressive chemotherapy regimen reduced the incidence of SOM by 65.0% ([incidence control- incidence active]/incidence control) as compared with placebo (Brilacidin: 25.0%; placebo: 71.4%; p=0.0480). For the Per Protocol (PP) population, Brilacidin-OM in the aggressive chemotherapy regimen similarly reduced the incidence of SOM by 80.3% as compared with placebo (Brilacidin: 14.3%; placebo: 72.7%; p=0.0249). Treatments appeared well-tolerated with good safety.
These data, with additional analysis forthcoming based on the Clinical Study Report, further support Brilacidin’s potential as a promising, and clearly differentiated, late-stage OM drug candidate and will help inform the planning and design of future trials. Brilacidin-OM is being developed under FDA Fast Track Designation.
“We are delighted to see Brilacidin-OM demonstrate such high, statistically significant efficacy in patients receiving aggressive treatment for HNC,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals.“Reducing incidence of SOM sets the gold standard and is key to capturing the large HNC market currently lacking any approved drugs. With this new expanded information on the effectiveness of Brilacidin-OM, coupled with our previously reported successful primary results, we think our novel compound continues to raise the bar as the leading SOM drug in development.”
The post is specious and maybe a bit disingenuous with a rhetorical device about how many BPs showed interest the past 5 years. Well, 5 years ago the company was still a Phase 1 biopharma. At the time the CEO stated the best deals come after Phase 2 trials, and the very best deals occur at Phase 3.The company is now Phase 2/3 with one more trial report on the way. The company has only just entered what he said would be his strongest negotiating position with a 3rd drug on the cusp of the same. Anyone who has been here for 5 years should know all this, and in a fair argument and criticism would acknowledge that the CEO has been clear about his intentions to court BP only at this juncture. Just this past February he announced ~20 CDAs, which is in keeping with what he said 5 years ago about what would be the conditions for eventual licensing agreements.
It’s not a manipulation story; it’s what market makers can do when filling bids. It’s part of “making an orderly market.” If a stock rises too quickly, they can (and do) fill further buying without covering shares, then fill the “open position” later. They absorb excess buying, just as they are supposed absorb excess selling (though that they rarely do). Effectively, they force a correction.
It’s a short target at 60 cents, >20% above the lows 2 weeks back. I expect MMs to fill opening buys on Monday with air shares, until volume picks up later in the morning. Aspire won’t be helping with selling, just like last week.
The design for the Phase 2a used input from an interested party, did it not? That would put it under a CDA. Who is to say the 2 patient OC study and its conclusion was not in a collaboration with and advising from PFE, among a number of other likely suspects? What I’m posting here is much more than speculation, or am I wrong about the design of that Phase 2a?
Advancement of nearly all pharmaceutical development halted from 2009 to 2010. That is not bullshit. The vast majority of pharmaceutical, including big pharmas, went into survival mode, just as did nearly every business dependent on funding and financing.
Not if the country and its economy are in crisis. In the US, almost all preclinical and clinical testing, especially the start of trials, came to halt from 2009 to 2010. This was especially true for university labs which were nearly all forced into survival mode. Only those projects fully prepaid continued to their conclusion. Italy’s universities did the same for its testing.
Yes it’s like that. All data is blind until all data is collected.
Those are bottoms and support. They are not floors. One must know the difference among the three if one is trading.
“meaning you personally will invest a couple hundred thousand bucks to keep price at/above 50 cents?“
I didn’t say that. But, the floor is in and many of us have enough shares. But, we will take more if need be. Moreover, we are tired of all the bullshit to drive down the price at the expense of future patients due to funding delays.
If you hold out for the forties, you will be holding out a long time. The floor is in. I didn’t say “support”, I said floor.
I didn’t call it support. I said it’s a floor. It’s been there for 2 weeks. I know it’s there because I’m part of it. Intraday has breached it three times, but closed each time above .5. Like I said, it’s a fact.
Agree. The floor is 50 cents, which isn’t filling. Anyone who wants shares over the next few weeks will need to hit the ask or at least bid above the 50 cent floor. If your L2 isn’t showing >25K shares on bid, your broker or other L2 provider is hiding bids. That’s a fact.
Very light buying, and no one selling except the little bit trickling into the bid between .5 and .51.
Prurisol results might also hold up a license if the plan is to use good P results to leverage upfront and milestone payments for funding advancement of the Brilacidin franchise into Phase 3 before striking a deal later for that much more lucrative platform.
Did you look at Aveo’s balance sheet? -586,969,000 accumulated deficit, with a net operating loss of over 65 million for 2017. No income from collaborations, partnerships or licenses. No income from approved drugs. They raised more than 586 million yet the share structure remains at just north of 100 million shares. How many reverse splits to raise 586 million and qualify for NASDAQ listing? Do you think they will spend another $65 million in 2018 to get approval in the US?
IPIX is actively seeking a license or partner that will raise as much capital over time as AVEO’s accumulated deficit. Maybe more if they license the B platform. Big difference between the two companies and business plans.
I think you over estimated earnings:
P/E ratio
325.61
325 times earnings yields 3.5 billion cap ($112 million earnings)? Are you sure this is a model multiple partnership? I don’t know, but with some sales approaching a billion dollars, what is it? Less than 1% royalty and fees? Please explain.
That depends upon the back end including any benchmark payments and royalties. For example, a partnership for the entire anti-inflammatory and antibiotic platform might include milestone payments for each indication from ABX to the entire GI track plus OM, and dermatitis, etc. It’s a huge expanse of separate indications. In fact, each general application can be considered a separate platform. Again for example, a partner might simply want the IBD platform. On top of a large upfront payment and milestones for UP, there would additional milestones for development of each of the formulations that reach other IBD disease areas. The license and structure of the agreement might take the SP to $20, but there would still be 3 other known platforms for development on the table. Plus, full monetization for IBD would still be in it’s early stages due to significant royalties.
As I said, those of us experienced with biopharma know how long it can take, beginning with waiting 12 weeks for the last patient to complete follow up and ending with final collection of data from all 30 plus sites. So, has it been 16 weeks yet? Well, it’s still the first quarter of 2018 until Sunday, so I would expect some announcement in the next 2 weeks.
Unblinding follows collection of all data and data lock. That’s why your post is not only wrong but... it’s just plain impossible for only some of the data to remain blinded. Those of us who know something about trials know this.
Complete nonsense. Why would Leo open up his blog to every troll on the internet? Why would he waste time and resources wading through “investor” posts? Anyone who has read SA knows what happens to blogs and what types of “investors” open forum blogs attract. What an incredibly stupid idea.
So, that’s why it’s back to .54, brick wall? Now I get it. The brick wall is plexiglass. I didn’t know that.
That's not my point. You said the antibiotic was shelved. That's not true. ABSSSI was shelved until after UP and OM.
So, I'm wrong that OM and UP include the need for antibiotic activity? I had no idea OM, caused in part by compromised immune system, was only anti-inflammatory. Interesting.
Testing of B against OM and UP deepened IPIX's understanding of its antibiotic activity as well as confirmed it as an effective anti-inflammatory. Or, am I wrong?
OM and UP are both antibiotic and anti-inflammatory. B as an antibiotic is not, was not, shelved. The 2 additional trials since ABSSSI have further added to B characterization, not changed it.
You currently can’t buy IPIX on margin. But, short interest can, if one uses several brokers who allow shorting OTC under $3.
You’ve been calling for a crash since the last one 10 years ago. Maybe this time you are right, but I doubt it. There is a nasty correction coming, but that plunge is still months off and won’t be 2008 all over again.
If IPIX has the goods and delivers a partnership in the coming month or two, it will be a bright green in an ocean of red. Even in the crash of 29, there were some winners. Same in 87 and 08.
Phase 2b is not just bigger, it was hosted by more sites and is more complicated. Why would it not take more than 1/3 more time than 2a, which took 9 weeks? It’s like increasing the diameter of a balloon by 1/3 and expecting the volume to do the same. 1/3 more volume, right?
I’m sorry, but that’s not “conspiracy BS.” It’s just how the market reacts pretty much every time. A reverse split is nearly always viewed negatively because it implies the need for more dilution after already heavy dilution. There are those who encourage such corporate actions because it can be so lucrative. So many startups reverse after the startup 50 or 100 million seed exceeds a billion shares.
IPIX is nowhere near the dilution requiring a reverse to survive, no matter what some may think about ~75% increase in shares over 10 years.
Absolutely true, except for the part where the market first punishes a company for the R/S, liquidates, then reloads at the new, lower valuation. Always happens whether the market punishment proceeds or follows the actual reverse event. I have never seen it not happen. Sometimes the punishment is twice, at the announcement then again after the R/S. For this reason dark forces love the R/S.
You left out cost. Effective drugs are expensive. Very expensive.
The Aruda share sales went into the Aruda bank account and added a swimming pool, a west wing, 2 summer houses on different continents and an island in Greece. What business is it of shareholders where the money went on the sale of personal shares other than filings until he had less than a reportable ownership in the company?
That’s bullshit. 5% VWAP is very favorable. Most other sources receive a discount from 10% to 30% up to as much as 50%. Pros know this. Now that is toxic financing. 5% is nothing.
That $6 million is nothing is especially true when any one of the Brilacidin indications, UP or OM, will fetch $25 million to $100 million upfront—at their current stage of development. Those are the facts.