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Oral Kevetrin perhaps? Hopefully we'll hear more about this soon, maybe in the 10-Q!
"...Earlier this year we achieved 50Gbps operation, and at this event we intend to show the broader PIC community that the platform is robust and we are finalizing actual demonstration devices that will be a stepping stone to the explosive demand for 400 Gbps modulator solutions.”
How do people read this? That they will have demonstration devices available at the upcoming PIC Training Event? Or is that just wishful thinking? Either way, sounds like they are close to a pivotal moment.
Anyone care to estimate the value of the B franchise for those current indications we have/had trials in (assuming B-OM topline matches interim)? Curious what B could potentially fetch in an outright sale of the asset at this point in time...
Current and/or completed Trials:
B - ABSSSI
B - UP
B - OM
Planned/On deck (I believe):
B - IBD/Crohn's
B - Hidradenitis Suppurativa
B - Acne
Should be getting close to the next PR over the next couple of weeks. We seem to be on the schedule of a PR every 6 - 8 weeks so hopefully there will be something new to talk about soon.
I'm pretty impressed with the pace of development here over the past year. Would love to see a CC scheduled for sometime in December to discuss what was/is achieved and what's next.
So - where do we fall given today's news?
I wasn't sure if waiting until ALL patients had 6 weeks worth of treatment/evaluation for a 6 week interim look would prevent any compromise of the trial and allow them to safely disseminate. If it's not that simple then it's not that simple, I don't have a background in this area and would never expect them to compromise trial integrity.
Would waiting to perform/release the 6 week interim results until the rest of the final patients have had 6 weeks worth of treatment and evaluation prevent any biasing?
It does seem improbable for Q3 based on that response - However, enrollment wasn't going to be complete until 9/1 based on the PR and 6 weeks of treatment after that is between 10/13 and 10/16.
Could they be waiting until ~6 weeks after the final patients were enrolled/started treatment to begin an "un-biasing" 6 week interim look? That could potentially allow for an interim results PR somewhere in late October, early November.
Excluding P-interim, what/when are the likely next major events for IPIX?
A P1 safety/bioequivalence trial should be fairly quick as it is in healthy volunteers and the number of patients would be small.
However, for a P2 study, does the primary endpoint HAVE to be PFS (progression free survivial?). Asking because I truly don't know, forgive my ignorance on this. They are trying to prove that Kevetrin is able to safely reactivate P53 in patients (tumors) is my basic understanding. Could that be the primary endpoint after completion of the course of treatment for each patient, rather than waiting to determine PFS?
For Phase 3 the primary endpoint has to be tied to PFS or OS is my understanding as you have to prove benefit to the patient. However, they could find them selves in a position for accelerated approval if all goes well.
I believe that information falls under the Section 7 Regulation FD which I believe is excluded from the 4 day requirement (although there may be another somewhere?) and appears to only require that material information be disclosed to all investors at the same time:
Regulation Fair Disclosure,[1] also commonly referred to as Regulation FD or Reg FD, is a regulation that was promulgated by the U.S. Securities and Exchange Commission (SEC) in August 2000.[2] The rule mandates that all publicly traded companies must disclose material information to all investors at the same time
Regulation Fair Disclosure,[1] also commonly referred to as Regulation FD or Reg FD, is a regulation that was promulgated by the U.S. Securities and Exchange Commission (SEC) in August 2000.[2] The rule mandates that all publicly traded companies must disclose material information to all investors at the same time.
https://en.wikipedia.org/wiki/Regulation_Fair_Disclosure
(I know, Wikipedia...)
https://www.sec.gov/fast-answers/answersform8khtm.html
"Companies have four business days to file a Form 8-K for the events specified in the items in Sections 1-6 and 9. However, if the issuer is furnishing a Form 8-K solely to satisfy its obligations under Regulation FD, then the due date might be earlier. "
The instructions for Form 8-K describe the types of events that trigger a public company's obligation to file a current report, including any of the following :
Section 1 Registrant's Business and Operations
Item 1.01 Entry into a Material Definitive Agreement
Item 1.02 Termination of a Material Definitive Agreement
Item 1.03 Bankruptcy or Receivership
Item 1.04 Mine Safety - Reporting of Shutdowns and Patterns of Violations
Section 2 Financial Information
Item 2.01 Completion of Acquisition or Disposition of Assets
Item 2.02 Results of Operations and Financial Condition
Item 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant
Item 2.04 Triggering Events That Accelerate or Increase a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement
Item 2.05 Costs Associated with Exit or Disposal Activities
Item 2.06 Material Impairments
Section 3 Securities and Trading Markets
Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing
Item 3.02 Unregistered Sales of Equity Securities
Item 3.03 Material Modification to Rights of Security Holders
Section 4 Matters Related to Accountants and Financial Statements
Item 4.01 Changes in Registrant's Certifying Accountant
Item 4.02 Non-Reliance on Previously Issued Financial Statements or a Related Audit Report or Completed Interim Review
Section 5 Corporate Governance and Management
Item 5.01 Changes in Control of Registrant
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
Item 5.03 Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year
Item 5.04 Temporary Suspension of Trading Under Registrant's Employee Benefit Plans
Item 5.05 Amendment to Registrant's Code of Ethics, or Waiver of a Provision of the Code of Ethics
Item 5.06 Change in Shell Company Status
Item 5.07 Submission of Matters to a Vote of Security Holders
Item 5.08 Shareholder Director Nominations
Section 6 Asset-Backed Securities
Item 6.01 ABS Informational and Computational Material
Item 6.02 Change of Servicer or Trustee
Item 6.03 Change in Credit Enhancement or Other External Support
Item 6.04 Failure to Make a Required Distribution
Item 6.05 Securities Act Updating Disclosure
Section 7 Regulation FD
Item 7.01 Regulation FD Disclosure
Section 8 Other Events
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.)
Section 9 Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits
Does anyone think we'll receive important news prior to the conference? (P - interim data or full enrollment, Partnership on B-UP, etc)
I have to wonder if they're planning/expecting an info release around the same time as the conference to generate maximum buzz while they're there.
Is it possible that less than stellar results would allow suitors to under-bid for B-UP/UC due to our need for cash? I would assume not, especially assuming multiple potential suitors provide bids and up the ante on eachother...
Sure - the link the to the time slot is here (just about all the way to the bottom as program details are ordered by date):
http://www.ddtwc.com/conference_program.php
As for a live-stream, I have not seen a link for that but imagine we will get a PR that contains the data highlights..
Presentation tomorrow is scheduled from 3:05- 3:25 pm Eastern time
So what time is the presentation tomorrow?
So, what are the upcoming events/timelines for Lightwave?
Great, that's what I am hoping for. Thank you.
I meant for B-OM, not B-UP. Appreciate the response regardless and hoping for that as well.
Curious if anyone knows - will there be additional interim results for B-OM released at the conference July 10 or just what we already know from the patient data provided earlier?
From today's PR:
Dr. Lebby commented, "Given the incredible technology advancement that the Lightwave Logic team has made over the past few years, it is now time for the world to recognize that polymer photonics--in particular polymer integrated photonics (Polymer PICs) are a critical component to the photonics roadmap going forward. This will be especially true for Polymer PICs that enable 100Gbps, 400Gbps performance and beyond."
Nice to see the confidence reaffirmed. Don't think you announce this to the world on that kind of stage unless your are 100% certain of what you have
Richard_LaRiv, thanks for the heads up I will be checking in over there. It is getting a bit hectic over here...
Question to add to the Conference Call this month:
What are the plans for uplisting???
Normally I'd interpret this quote as indicating that they will command a much higher buyout price by 2018...
However, Lebby seems so enthusiastic and confident in this letter that you have to wonder if his goal and motivation is to build the company out and see this technology through to fruition personally.
Curious how you all read this?
Great questions Gates - have you sent over to Steve C for consideration before the CC in May? They may find it helpful to prepare in advance and possibly address in any presentation.
...we have already begun exploring packaging designs to prepare for customer evaluations.
"We expect that the 25Gbps device will generate significant industry attention as we squarely address powerful, cost-effective miniaturized solutions for both today's 100Gbps, and future 400Gbps higher performance markets."
GREAT!!!
At the 4:48 mark.
Have to imagine they are getting pretty close to fully enrolled with 24-25 sites initiated since mid-December for the Prurisol Ph2b trial, with sites having begun screening in November 2016 for those that came on board early...
My guess is that the Annual Shareholder Meeting in May was planned to correspond with expected, more significant developments...
Still hopeful to hear something before the conference next week though.
Did anyone notice that Acne is now listed under the Brilacidin Pipeline? Maybe I'm late on this one but I just picked up on it.
http://www.cellceutix.com/stages-of-development/
This is a fairly normal startup time (2-3 months). I have a friend who manages clinical trials and they mentioned that for rarer indications, or more competitive patient populations (large number of competing trials ongoing for same indication) it can take 6-8 months to activate new sites although a less usual scenario.
When is the conference? tia
Lightwave Logic Obtains Highly Successful Independent Third Party Verification of Its Organic Polymer Thin Film Properties
Material Test Results Demonstrate Low Optical Loss of Lightwave's Organic Materials
LONGMONT, CO--(Marketwired - August 25, 2016) - Lightwave Logic, Inc. (OTCQB: LWLG), a technology company focused on the development of Next Generation Photonic Devices and Non-Linear Optical Polymer Materials Systems for applications in high speed fiber-optic data communications and optical computing, announced today that Metricon, a company that specializes in making precision instruments designed to obtain optical measurements on thin film materials and optical waveguides, concluded a battery of scientific tests to verify the inherent properties of several of Lightwave Logic's advanced organic electro-optic polymer materials, which are currently being implemented into a series of photonic devices.
Measurements by Metricon of several planar waveguide samples have determined that Lightwave's polymer thin film materials at 1550 nm (Telecom frequency band) should exceed industry requirements that target overall device loss at <4 dB/cm. Additionally, they were also able to provide very accurate refractive index measurements on Lightwave's materials, which is very important for designing high-speed multi-layer polymer modulators.
Metricon's instrument is capable of obtaining precise data on several parameters that include: material thickness, refractive index and optical loss. These parameters are essential to the development of optical devices for Datacom and Telecom network providers.
Tom Zelibor, Chairman and CEO of Lightwave Logic, commented, "We have gained extremely important information relative to our company's future success. This data gives us the confidence that the quality of our material systems will allow us to narrow our efforts on optimizing our optical devices to take advantage of the superior capabilities that our materials have demonstrated.
"The Metricon testing has given us the precise capabilities of our current material system and our development engineers are focusing on achieving superior results using those materials in our device program.
"The really good news here is that these results give us full confidence that the inherent capabilities our materials will lead us to photonic devices that will offer significant competitive advantages over an installed base of legacy products. This represents billions of dollars in market opportunity."
John Jackson, President of Metricon, added, "Based on our measurements, it does appear that these materials will dramatically exceed the 4 dB/cm industry requirement at 1550 nm."
For more information about Lightwave Logic, please visit the Company's website at following URL: www.lightwavelogic.com.
10-Q should be out in the next 2 weeks, I imagine we'll get a much better picture of their financial situation and near-term projected spend for each platform. Should be interesting.
Would certainly be nice if they were under-promising on delivery timelines...
Is it possible that CTIX is pursuing a partner for the B ABSSSI indication now that P is going into a Phase 2b study?
With the numerous different indications for any of their 3 platforms (B, P, K), partnering for just one indication even at a lower value could potentially provide enough cash to assuage any funding worries in the interim.