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And Alfa Sigma has only first right to refusal on Bril-UC and Bril-Crohns. No first right to negotiate for Alfa Sigma.
There could be some bigger players coming in early on Bril-UC as the reason to not give Alfa Sigma first right to negotiate.
I agree with you.
A possible way to close the BOM deal:
co-license agreement
1st BP gets USA license 5 mill upfront and their portion of trial cost shared is 6-7 million
2nd BP gets European license 5 mill upfront and their portion of trial cost shared is 6-7 million
And save the Asia License for financiers, see what you can squeeze out of them
I have emailed CEO about BOM negotiations - hoping they are considering at least a regional USA license (say part of East Coast) if they finalize a BOM deal to begin a Phase 3. A license to Inventory, Distributing and Marketing sugar like sachet packets should be quite cost effective and profitable in consideration for some equity financing. BOM if approved, can become an at home treatment, quite less the expense and hassle of IVs. Insurance companies would love it.
I agree about the doubling in size being too much.
Hope they are just considering
Building up the financing in the Irish subsidiary for some future operation(s). With that funding related to
1. Advancing oral Kevetrin thru an external formulator.
2. Finalizing a BOM deal with minimal equity financing.
Maybe BOM, and any successful UC and Kevetrin trials will require equity financing to achieve better deal terms.
Did you write to him in form of a letter as certified mail (signature upon receipt)?
or
Are You using read receipts in your email?
If you own # shares that you say, I'd certainly want some possibility answers on this one.
There were probably not going to be any deals for BUP or BOM before the Prurisol Phase 2B results were known in Nov/Dec 2018, to see if they could leverage good Prurisol results in deal making for B.
Thank you twice :)
Enrollment for B-ABSSI was completed on August 20 and Sept 9 they made comments on blinded data well before top line was released on October 23.
Are 100% blinded case report forms (CRFs) given to the company after completed last patient. The CRFs should be a completely payed service when the final CRF is done for the last enrolled patient.
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-completes-enrollment-in-phase-2b-clinical-trial-of-brilacidin-for-acute-bacterial-skin-and-skin-structure-infections-absssi
Below were the comments on blinded data - it does not say whether the blinded data was in IPIX possession yet.
Cellceutix Provides Initial Observations of Completed ABSSSI Phase 2b Trial; Company Submits Investigational New Drug Application to FDA for Phase 2 Trial of Brilacidin-OM for Oral Mucositis
Dosing Increases Approximately 65% in Cancer Drug Trial
BEVERLY, MA--(Marketwired - Sep 9, 2014) - Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, is pleased to announce this update on its recently completed Phase 2b study of Brilacidin for the treatment of Acute Bacterial Skin and Skin Structure Infections ("ABSSSI").
The study was a 215-patient blinded trial with four treatment arms and approximately 50-55 patients per arm. Three of the arms evaluated Brilacidin, two single-dose arms and one 3-day regimen, and the fourth arm was daptomycin of once per day for seven days. Daptomycin for injection is marketed by Cubist Pharmaceuticals under the brand name Cubicin® and generated approximately $447 million in sales in the first half of 2014.
The initial results from the study are general observations and only considered blinded data averaged across all four treatment groups. Similar to a previously conducted Phase 2a study, Staphylococcus aureus (including MRSA) was the most common bacteria isolated at the baseline visit. The data shows that by Day 7, the average cure rate for all four treatment arms was higher than what was observed in the phase 2a study, and similar to -- if not higher than -- cure rates reported for common ABSSSI drugs, as well as those approved this year. Because 3/4 of the patients in this study were treated with Brilacidin, this high average cure rate is heavily influenced by Brilacidin, and less influenced by daptomycin, which only 1/4 patients received. This also means that the two single-dose treatment arms are providing half of the data toward this positive average cure rate; and if these data hold up, a single-dose regimen of Brilacidin would be the Company's Phase 3 study design.
Cellceutix will not know the actual cure rates per treatment arm until the data is unblinded in October/November. However, the Company is very optimistic and views the high average cure rate on the blinded data as a very good sign for Brilacidin. Assuming positive results after unblinding, Cellceutix will have proven that Brilacidin is a safe and effective drug in the Phase 2 trial, and all activities will be triggered for initiation of a pivotal Phase 3 trial.
"We are very excited about the prospect of using a novel class of antibiotics to treat serious infections caused by Staph aureus, including MRSA, and potentially, with a single-dose," commented Dr. Krishna Menon, Chief Scientific Officer of Cellceutix. "Because of the extremely unlikely chance of developing resistance, and the other benefits conferred by a short or single-dose therapy, such as near 100% compliance, we feel Brilacidin is a game-changer in the field of antibiotics for serious and resistant infections."
http://www.ipharminc.com/press-release/2016/11/16/cellceutix-announces-positive-top-line-data-from-phase-2b-absssi-trial-single-dose-brilacidin-comparable-to-7-days-of-daptomycin
One thought is those pharma parties under confidential CDA's for Prurisol DO NOT WANT the CEO to make public comments about finished blind data.
A comment (I believe) was made by the CEO about the blinded arms near the end of the Phase 2B ABSSSI trial and projection % chance of Brilacidin non-inferiority to Daptomycin.
Does anyone remember this...?
If so,
is IPIX allowed/not allowed to comment on blind data at end of Prurisol 2B trial based on this current CRO contract??
Is 57% Prurisol (2 arms) vs 43% placebo (1 arm) with only 300 mg Prurisol arm and placebo arm being equal in patient numbers not good enough to comment on blind data?
Believe Phase 2B ABSSSI was 3 out of 4 arms being Brilacidin with patient numbers in each of the 4 arms being about equal.
I was able to email the CEO twice last nite.
Both were delivered successfully using Leo@ipharminc.com
If BTD was written up as a milestone in the term sheet,
bet it's quite a better amount than the 1 million milestone from the 9/30 Aspire agreement.
A 17 patient Breakthrough Therapy Designation.
http://investor.bluebirdbio.com/news-releases/news-release-details/fda-grants-breakthrough-therapy-designation-lenti-dtm-treatment
My response in bold:
A term sheet contains the base financial numbers for starting negotiations.
IPIX may be sitting on still active unsigned term sheets due to a possible exclusitivity clause (exclusivity period for negotiating) in the current 10K agreement.
This was the first time that B-IBD was mentioned to be paired with B-OM in negotiations with the 10K agreement made in August.
There could be an exclusivity clause.
Exclusivity provides the parties with assurances that their anticipated deal won’t be scooped up or pre-empted by a competing offer by another party during the exclusivity period, and confidentiality provisions protect material, confidential information.
Edit: That's an excellent bit of news that may offset the news of the Prurisol result delay.
https://www.sec.gov/Archives/edgar/data/1355250/000147793218004457/ipix_10k.htm
Quote:
The Company signed a non-binding term sheet in August 2018 with a global pharmaceutical company for the licensing/rights to Brilacidin for treating oral mucositis and inflammatory bowel diseases. Initial payments, milestone payments and royalties are being negotiated in accordance with the non-binding term sheet. The pharmaceutical company is now engaged in further due diligence. Management can offer no assurances that the parties will enter into a binding definitive agreement.
The company will be staying in the current office. Scroll down to Lease Commitments
That may be the sequence, I'm happy B-IBD was added to the term sheet.
Some global pharmaceutical appears interested now in both B-OM and B-IBD development.
See this as additional good news.
Agree, previously it was B-OM in a Business Development agreement. Now B-IBD has been included.
The Company signed a non-binding term sheet in August 2018 with a global pharmaceutical company for the licensing/rights to Brilacidin for treating oral mucositis and inflammatory bowel diseases. Initial payments, milestone payments and royalties are being negotiated in accordance with the non-binding term sheet. The pharmaceutical company is now engaged in further due diligence. Management can offer no assurances that the parties will enter into a binding definitive agreement.
https://www.bio.org/sites/default/files/files/TERM%20SHEET%20EXAMPLE_CUPIT%20AND%20SINATRA.pdf
Well, actually 89 days til Sept 28 if they applied on July 2nd (Monday)...
[ Yes Karin,
When was BTD submitted? ]
....
Was the July 17th finalizing of the CORERX sachet manufacturing deal (for Brilacidin-Oral Mucositis) the final piece before the BTD request was submitted?
http://www.ipharminc.com/press-release/2018/7/17/innovation-pharmaceuticals-signs-drug-product-manufacturing-contract-with-corerx-to-formulate-and-package-brilacidin-for-oral-mucositis-in-sachet-form
One would think they only told Aspire that they were filing for BTD at an appropriate time in the 3rd quarter of 2018 that would obtain a response by Sept 30th.
July has 31 days, August has 31 days = 62 days total
plus 28 days in Sept (Friday Sept 28) = 28 days
Total days for July/Aug/Sept for max BTD response from the FDA is 90 days which would occur on Sept 28.
Milestone deadline is Sept 30 (Sunday)
In regards to Breakthrough Therapy Designation:
Most submissions reviewed in 60 days or
less*
Limited types of submissions require 90 days
Reference Slide 12 @ :
https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/UCM452716.pdf
None of us know when the end of phase 2 meeting took place and when BTD was applied for.
The end of phase 2 meeting certainly took place at least 4 weeks after the May 9 PR because the FDA requires the meeting package (bring the data) to be submitted 4 weeks prior to an actual end of phase 2 meeting.
MAY 9 PR about concluding data analysis:
http://www.ipharminc.com/press-release/2018/5/9/innovation-pharmaceuticals-concludes-data-analysis-of-its-phase-2-clinical-trial-for-severe-oral-mucositis-in-head-and-neck-cancer-positioning-to-fill-a-substantial-void-in-supportive-cancer-care
Ideally, a Breakthrough Therapy designation request should be received by FDA no later than the end-of-phase-2 meetings if any of the features of the designation are to be obtained. Because the primary intent of Breakthrough Therapy designation is to develop evidence needed to support approval as efficiently as possible, FDA does not anticipate that Breakthrough Therapy designation requests will be made after the submission of an original BLA or NDA or a supplement. FDA will respond to Breakthrough Therapy designation requests within sixty days of receipt of the request.
https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm
The ? may be when the end of Phase 2 meeting took place for Brilacidin-OM. My guess would be the end of Phase 2 meeting occurred after the July 17 PR announcing the CoreRx sachet agreement for Brilacidin-OM.
http://www.ipharminc.com/press-release/2018/7/17/innovation-pharmaceuticals-signs-drug-product-manufacturing-contract-with-corerx-to-formulate-and-package-brilacidin-for-oral-mucositis-in-sachet-form
A Breakthrough Therapy Designation request is due to the FDA by the time an end of Phase 2 meeting begins.
Found it interesting that no mention of
$1 million for $5 million upfront deal or
$1.5 million for $7.5 million upfront deal
The quote below is giving a target minimum of $10 million upfront, but no max cap on that double-digits millions of dollars. Seems like IPIX is focused on a double-digit millions upfront for 1 or more clinical assets. Think maybe its closer to 10 million than 15-20 million upfront, that IPIX may concede to agreement of this amount to get that first deal done.
Terms probably already baseline frameworked.
My guess would be proceed with sachets of sugar like packet BOM in phase 3 with cisplatin every 21 days for 7 weeks. And a non-phase3 for other delivery method(s) would follow behind this as the testing, hopefully close in parallel to a sachet type phase 3.
It would appear the potential partner(s) want to see B moved forward to next trial prep as the priority (especially BOM), regardless of while waiting for P results. Hence, some money is committed and raised towatds BOM development, negotiations and possibly other B trials dermatology and not throwing away in Quarter 1 all 2.7 million owed to CRO for P results out of the 3.3 million balance on 12/31/17.
Thank you!
It's about finding the efficacy window thru reasonable dosage increments in conjunction with what type of patients will most likely respond.
Is your repetitive basis for failure due to P2A results for moderate psoriasis at 200mg dosage only?
Maybe you should give 300 and 400 mg a chance.
What is your P2B Prurisol PASI 75 % range for acceptance of failure that you continue to express?
Provide concrete details if the effort is not too herniating.
Okay, I rewrote concerning the math and did the website thing..thanks. I don't hang on here much, credibility issues and FUD and irrational exuberance don't give this board a sense of honesty and good character thru some of the information spread here.
Where is the credible source to post #224808
My correction: already 19 days into Q2 and my 8 days til Q2 is an error.
I still find it perplexing that something would be relayed w/o either an email box snapshot image (is this is even reliable) or credible source.
Company letterhead logo with an actual signature and date verified letter (handwritten best) from Bertolino/Ehrlich and displayed here would be closest to believing.
Where is your credible source shown on this message board for direct information from the company that results are due in Q2 2018.
It's easy to say Q2 2018 for results as a lone typist when the Q2 time is in 8 business days.
Reference source please...
Your correct. A lot of these posts predicting fate of Prurisol results based on length of timeline for results is a 4-5x per week circle of nothingness.
It's the same folks lacking maturity and emotional intelligence.
Yes, 3 high doses of cisplatin every 21 days indicates a preferred category 1 level of treatment. And in all of those treatment regimens displayed in the leftmost table column, there are only 3 that are category 1. The remaining treatments are lower (least recommended) treatment categories of 2A and 2B. Note that 3 high doses of cisplatin every 21 days is the only category 1 treatment that is prefixed with the word preferred.
Table of head and neck cancer treatment regimens below:
https://www.cancertherapyadvisor.com/head-and-neck-cancer/head-neck-cancers-treatment-regimens/article/218124/
Emphatic agreement with your points 1-3.
Sounds like you read and interpreted Galera's Phase 1 presentation horizontal bar charts.
Curious why they did not provide similar presentation graphs for their Phase 2 or are those forthcoming. MEDIAN seems to be a comfortable reporting style.
Yes 1) prevention and 2) duration before SOM begins and how long --- should be classified seperately...no pooling together.
Dr Bertolino most likely waiting on Prurisol results to see how they would factor into an aggregate value for a deal.
No point jumping the gun on achieving a fully maximized deal.
At this point it's only a failure if it doesn't go to Phase 3.
And Celgene had 61 greater # of patients to process in those 100 days compared to IPIX.