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I’ve lost so much weight the past 5 years and have retired as a professor; I no longer qualify as “big kahuna” in any sense of the phrase.
George, that assumes other mechanisms do not appear that may be antagonistic to desired outcomes. Safety to 600 mg daily may be safe, but we don’t know what downstream interactions he will appear after 200 mg daily.
I agree about dose dependency, but let’s just wait for data before declaring anything.
The bar is pretty low. We only need ~35% PASI 75 to be a blockbuster.
Edit: Wrong discussion.
The proof that the interim analysis and unblinding did not take place is the reasoning, unblinding the trial might jeopardize impartiality and insert bias. The trial was not unblinded at the scheduled interim because unblinding would have had the effect they wanted to avoid. How hard is that to understand?
In looking for accelerated approval under a 5052b, the FDA would pounce on an interim unblinding and likely require a statistically reliable Phase 3, maybe even 2 of them. They would even cite possible investigator bias if the results were too good.
I’m not buying the poor results/failure argument at all. It makes more sense that raw, blinded data showed stronger results than expected. Then Leo and officers would want to protect the study integrity from criticism by canceling the interim.
Or corrupt.
A question that will not be answered until the data is unblinded.
As many pointed out, the long collection period is most likely due the surveys. Answers on those surveys will make an impact on the FDA’s BTD decision and especially accelerated approval.
What part of “still blinded” is ambivalent or hard to understand?
The point I was getting at in the linked post is what you state.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=140254283
“Yes, it has to be approved for commercial use. That’s what the CMC is for. The production can be used for both trials and commercial use, if approved.
For example, if B-OM accelerated approval is under Phase 4 guidelines then that would be commercial use.”
I didn’t think it was necessary to provide the link to someone who was the first to report the PR after its release.
http://www.ipharminc.com/press-release/2018/4/23/innovation-pharmaceuticals-signs-drug-supply-contract-with-evonik-to-bulk-produce-commercial-grade-brilacidin
Happy to. Surprised you missed it: first line of the text, “As we await the unblinding of the Prurisol clinical trial,...”
You’re right, it’s not a complex molecule. But, it is for multiple modes of delivery: oral rinse, retention enema (likely a foam), IV. Upcoming, oral delivery. Manufacturing and packaging for those commercial uses are more complex than a small molecule would suggest. This is getting out ahead of the curve for a potential partner saving both future time and money. One less worry for a partner.
The PR didn’t “dismiss P2b.” It stated P2b was still blinded.
There is nothing to add until unblinded.
Yes, it has to be approved for commercial use. That’s what the CMC is for. The production can be used for both trials and commercial use, if approved.
For example, if B-OM accelerated approval is under Phase 4 guidelines then that would be commercial use.
The data is still blinded. What is he supposed to say? There is nothing to say until the data is locked and unblinded. Get over it.
You misread the PR. It is about a global manufacturer and a contract for commercial CMC. This is another step toward a license, and that license can still easily be any BP. It further mentioned that the Prurisol trial data is still blinded.
IPIX is between trials. That doesn’t mean there are no trials. There are 3 indications advancing to Phase 3 and one with data blinded having completed Phase 2. Today’s PR confirmed that all B variations are moving forward and Phase 3 trial proposals to the FDA are in process. At this point progress is seeking approval for the next trial designs that will include all elements for accelerated approval. This is how biopharma works. The easier and clearer the pathway to approval the greater the value of each drug version to BP. That is also drug progression.
The cart isn’t before the horse if the commercially produced product is used in trials. It shortcuts the process for market approval when done at the current stage. It also applies to accelerated approval and BTD as a step not needed ahead of marketing.
Having a commercial manufacturer in place is an advancement in the approval process. There is no other way to see it. Commercial capacity and CMC documentation are all part of the process in drug development toward market.
Having a commercial B producer in place sweetens the pot for a BP; it doesn’t diminish in any way. It’s one more thing they don’t have to do. It’s one more delay to approval and market they need to worry about.
It’s not fluff. Contracting a manufacturer for the final CMC for commercial production is a milestone. Having the CMC paperwork in hand going into Phase 3 will expedite and smooth over pathways. This is especially true for B-OM which looks like a lock for BTD. A commercial manufacturer now means not needing to develop one later, after Phase 3.
Data lock means nothing more can be added to the database. In trials data unlock does not mean result release, rather exactly the opposite. In a blinded trial, unblinding can’t take place until all data is locked at which point the results are analyzed.
What was described was not “ I thought it up.” It’s actually in the 505b regulations and guidance which the Prurisol 2b is under. I’m trying to figure out what part of that is so hard to understand.
Brilacidin for oral mucositis, the drug referred here as B-OM, is an unmet need against a debilitating and deadly side effect of radiation and other immune compromising therapies. The bar for approval is very low. B-OM treatment resulted in up to 80% prevention in some subgroups and an overall prevention of more than 20% overall when compared to the study placebo group. B-OM is nearly a lock for approval and IPIX is in the process of applying for FDA breakthrough therapy designation.
Some big pharma will want this drug; it’s only a matter of which BP, how many other Brilacidin indications BP might want in addition to B-OM, and final valuation and license/partner structure.
Let me get this right: there is a regulatory explanation for the long period between the end of trial and the locking of data followed by analysis and then release. IPIX’s Prurisol trial squarely falls under those rules and regulations, but you reject it because Leo didn’t say so? What contemptible bullshit.
Best bid is also fractional and the judgment of the market maker. When a fractional cent bid all or none appears with a specific number of shares then a matching share count ask fractional, that bid becomes best bid. I know this, and I’m surprised that you don’t.
Same quote to you, “Are you going to believe your own eyes or believe me?”
“Are you going to believe your eyes or me?”
I know what I watched in real time on Wednesday and then yesterday. It doesn’t take a genious to figure out something is fishy when you have bids in at .5 and .51 only to watch a half cent to a cent fill below them. One does not need 20/20 insight to watch those same bids fill at .49 when the ask lowers thus taking out the .50s.
Because 2 days ago 50 cent bids were skipped to fill under 50 cent bids including fractional bids, those 50 cent bids were then filled at 48-495 just before the price was walked down to .45. That’s why we scream “manipulation.” My mistake was calling a 50 cent floor not realizing corrupt market makers would just take that as a challenge.
BPs got all the contact numbers they needed at those conferences that so many here complained about being worthless. CDA holders have all the emails and direct numbers they want and need.
Bullshit, bunny. It’s been a disaster primarily because of attacks and shenanigans from the likes of Mako and other such liars about the IP and management. There are even those like Mako who have claimed to wish success for IPIX all the while posting constant attacks.
I talked to Leo about that and he said many emails and calls easily trace to hedge funds and market makers, as well as origins already red-flagged by his investigators.
Respectful inquiries, my ass.
There were no floor calls for those levels. Those were bottoms within trading cycles of highs and lows. Knowing the difference can save one from losing houses as one should not be over-investing in high risk ventures at cycle tops. Yes, I also recently bought shares above .7 up to 1.05. If I were less certain, I would have flipped profit instead of accumulated.
Admittedly, this is a bit hypocritical as I am now overweighted (>5% in portfolio) in IPIX. But, I’m prepared to go above 10% if need be, from this floor. There are others with even more ready to buy to support the 50 cents. One can let 48 to 50 trickle in with patience and MM help, but if you want to load, hit the ask.
“...get on the phone and chew some ass...”
This is waiting patiently? Patiently on the phone chewing ass, I think not. I agree with others, 12-16 weeks, we are now at the any day stage.
Someone said Leo should have 85% of the data in hand, maybe true, maybe not, but what the hell can Leo release until the data is locked and then unblinded?
Watch and learn.
The floor is 50 cents. The intraday bid is locked at .49. Anyone who wants shares needs to hit the ask at .5. No one is going to get anything but a trickle at .49. Just like yesterday.
Innovation Pharmaceuticals Data from Phase 2 Brilacidin Oral Mucositis (OM) Trial in Head and Neck Cancer Show Notable Reductions in Median Duration of Severe OM and in Number of Unplanned Visits/Hospital Admissions Due to OM
Innovation Pharmaceuticals Data from Phase 2 Brilacidin Oral Mucositis (OM) Trial in Head and Neck Cancer Show Notable Reductions in Median Duration of Severe OM and in Number of Unplanned Visits/Hospital Admissions Due to OM
Median Duration of Severe Oral Mucositis (SOM) Reduced to Less Than One Day
No Unplanned Office Visits, Emergency Department Visits, and/or Hospital Admissions Due to OM in Brilacidin-OM Arm vs. Four in Placebo Arm
Data Align with Previously Reported 80.3% Risk Reduction in Incidence of Severe OM in Per Protocol Population Receiving Aggressive Chemotherapy Regimen Compared to Placebo
BEVERLY, MA – April 16, 2018 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report additional information from the Company’s successfully completed Phase 2 clinical trial of Brilacidin-OM (see NCT02324335) for the indication of decreasing the incidence of Severe Oral Mucositis (SOM) (WHO Grade ≥3) in Head and Neck Cancer (HNC) patients receiving chemoradiation.
These additional data align with previously released Brilacidin-OM results showing a risk reduction in the incidence of SOM, including up to an 80.3% risk reduction in the incidence of SOM among patients receiving more aggressive chemotherapy. Other previously released results indicate Brilacidin-OM also delayed onset of SOM. The Company is developing Brilacidin-OM under FDA Fast Track designation as a convenient, and clearly differentiated, therapy aimed to decrease incidence of SOM.
Secondary Endpoint: Duration of SOM
Brilacidin outperformed placebo in both the Initial Instance Duration of SOM and the Overall Duration of SOM, as shown below.
Placebo Brilacidin
mITT PP mITT PP
(N=25) (N=20) (N=21) (N=19)
Initial Instance Duration (Days)
Median (50th Percentile) 3 3.5 0 0
Overall Duration (Days)
Median (50th Percentile) 3 5.5 0 0
Initial Instance Duration of SOM was defined as the number of days from initial WHO Grade ≥3 during radiation therapy to the first WHO Grade 2 or lower OM Grade. Overall Duration of SOM was defined as the number of days from initial WHO Grade ≥3 during radiation therapy to the day prior to the next OM assessment after the last WHO Grade ≥3 during/after radiation therapy. Note: 50th percentiles are from Kaplan-Meier analysis. Patients who did not experience SOM have duration set to 0.
Previously, the Company reported statistically significant results showing Brilacidin-OM reduced the incidence of SOM in HNC patients receiving cisplatin administered in a high-dose regimen (80-100 mg/m2), approximately every 21 days. For the Modified Intent-to-Treat (mITT) population, Brilacidin-OM in the high-dose 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 high-dose chemotherapy regimen similarly reduced the incidence of SOM by 80.3% as compared with placebo (Brilacidin: 14.3%; placebo: 72.7%; p=0.0249).
Exploratory Endpoint: Unplanned Office Visits, Emergency Department Visits, and/or Hospital Admissions Due to OM
Positive OM assessment endpoints are additionally supported by zero (0) of the patients in the Brilacidin-OM group having unplanned office visits, ED visits, or hospital admissions due to OM, compared to four (4) patients in the placebo group.
Other Study Observations
Regardless of the oral sites irradiated (at least two sites from: buccal mucosa, floor of mouth, ventral/lateral tongue, and soft palate), the incidence by patient of Severe OM on Brilacidin-OM relative to placebo was consistently reduced.
Across cumulative radiation dose intervals, patients in the Brilacidin-OM group consistently reported less often feeling the sensation “swollen” (approximately half of that reported for the placebo group). “Burning” sensation also was reported consistently less frequently in the Brilacidin treatment group.
Patients in the Brilacidin-OM group appeared to trend more favorably over the course of chemoradiation treatment according to Eastern Cooperative Oncology Group (ECOG) Performance Status—a common set of criteria used in oncology trials to assess debility.
Management Comments
“Drug makers, the world-over, have spent decades and enormous sums in both money and resources trying to develop an effective OM drug in a bid to address dire patient needs as well as capture a tremendous market opportunity,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Yet, there is currently no drug approved to treat, let alone prevent, severe OM in patients with Head and Neck Cancer. Most Pharmas currently conducting OM trials target shortening the duration of severe OM as their primary endpoint, not reduction of incidence, like we did. The Brilacidin-OM Phase 2 trial met its primary objective and its key secondary objectives. As we continue to analyze subset data, we are extremely enthusiastic about observed trends. Hundreds of thousands of patients would benefit from a preventative OM treatment and we’re excited that Brilacidin-OM may one day provide these patients a much-needed breakthrough treatment option.”
Skin Structure Infections. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations, and has successfully completed a Phase 2 trial in ovarian cancer. Prurisol, an oral psoriasis drug candidate acting through immune modulation and PRINS reduction, completed a Phase 2b trial with topline results expected in 2Q2018.
More information is available on the Company website at www.IPharmInc.com.
There are a lot of us at the floor. 50 cents is not a mirage. Yes, bids did fill at .49, but if you’re a buyer, you need to step up and hit the ask, period. Very few shares will continue to be available under 50 cents.
Fifty cent floor is not a mirage. It closed above .5. Never went lower than .49. Picked up a few more today.