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Patent 11,042,051 refers to "The direct-drive region-less polymer modulator as claimed in claim 1 wherein the multilayer waveguide has a propagation loss less than 2.2 dB/cm with device insertion
loss less than 6 dB."
It also states the device has r33 > 250 pm/V and drive voltage of about 0.5V.
Could you elaborate an whether or not those numbers are what the industry is looking for, and how today's announcement affects them?
I'm still trying to piece together a better understanding of where the company is and what it still needs to do.
Something to note in comparing the referenced paper to the most recent LWLG patent regarding thermal stability. In the paper on page 30, in a discussion of 'Future Outlook' of electro-optic polymers, there is this:
Further improvement in EO polymers will lead to devices that can efficiently and stably operate at elevated temperatures (as high as 100C), which is beneficial for installation in harsh environments or translates into reduced energy consumption for the cooling systems and lowers running costs in data centers. Such devices were very recently demonstrated in Ref. 255, where a high glass transition temperature is essential for the thermal reliability and long-term operation; Tg values exceeding 200C have already been
reported.
The electro-optic polymer core has an electro-optic coefficient (r33) greater than 250 pm/V, and a Tg 150° C. to
>200° C., and the top and bottom electro-optic polymer
cladding layers having a Tg approximately the same as the
Tg of the electro-optic polymer core.
forztnt2 - thanks(?!). I'll try to wade through this. I'm an environmental engineer (a specialty of civil engineering) with more chemistry and math than required for a bachelor's degree. I understand bits and pieces of the tech, more on the chemistry of the chromophores, but very little of the electronics/photonics part. Knowing what the units are and what the numbers mean is the what I am mostly trying to grasp. The diagrams in the document are very helpful since I have no grasp of what the components look like and how they fit together.
Looking at the text along with the figures, on figures 8A and 8B, which show 'prior art' (current technology), the voltage is 0.5V with an added rf driver.
Figures 9A/9B show LWLG's patented modulator, also with 0.5V, with no rf driver. The text describing this figure (page 21, paragraph 0043) states:
... an rf modulation signal 25 of approximately
0.5V, and generally in a range of 0.2V to 0.5V, is applied
directly to one end of U-shaped electrode 22 and the other
end is connected through a 50 ohm termination 26 to ground.
Similarly, an rf modulation signal 25' of approximately 0.5V
is applied directly to one end of U-shaped electrode 22' and
the other end is connected through a 50-ohm termination 26'
to ground. Thus, two examples of direct-drive polymer
modulators (DDPM) are illustrated in FIGS. 9A and 98. In
this preferred embodiment, each of modulators 20 and 20'
use an EO polymer with an r33 >250 pm/V and generally in
a range of 250 pm/V to 750 pm/V.
Also see the PRs dated January 13, 2021, and May 11, 2021. These discuss patents for manufacturing processes to protect the devices, improving reliability.
I'll take you at your word that you are an investor an not here to spread negativity.
I can't address the developments in Japan. I'll address the thermal stability question, which may be from a post on another board and not from an expert. It was from several years ago. LWLG has addressed this many times. Here are some quotes from the 2017 annual report (issued March 2018):
In January 2014 we created a new methodology to combine multiple chromophores into a single polymer host that significantly improves their ability to generate more powerful organic, nonlinear electro-optical polymer systems. The new synthetic chemistry process can enable multiple chromophores (dyes) to work in concert with each other within a single polymer host. This proprietary process has created two new material systems, which have demonstrated outstanding electro-optic values. In addition, we now have a significant amount of data on the thermal aging of our materials. We have demonstrated that our materials can withstand more than 2,000 hours at 110 degrees C with little to no change in electro-optic activity in our materials, which is a significant milestone. To our knowledge, this is something that has not been achieved before in any polymer. We are also concurrently coating prototype waveguides with our proprietary material system
In August 2015 we completed 2,500 hours of thermal aging tests of several blends of materials created by our multi-chromophore process,which included lengthy exposure to high temperatures (850C and 1100C). The data collected indicated minimal loss of electro-optical activity (R33)of our materials, which means that our organic polymers are expected to provide decades of operational performance. These results exceed previously published efforts for other organic polymers and are an important part of our commercialization effort as we begin to implement these material systems into advanced photonic devices for the telecom and datacom markets.
In October 2015, we successfully surpassed 2,000 hours of photochemical stability testing of our material candidates with little to nochange in the electro-optic characteristics (R33) of our material; and, in January 2016, we successfully surpassed 4,000 hours of photochemical stability testing of our material candidates with little to no change in the electro-optic characteristics (R33) of our material. These photochemical stability test results, along with the thermal stability at 110°C, should enable our Company to demonstrate that organic polymers can compete head-to-head with inorganic crystalline legacy telecom and datacom devices which currently provide the backbone for the entire infrastructure that converts almost incalculable amounts of electronic (binary) data into pulses of light and back on a daily basis.
The company also presented thermal stability data of the activated (electro-optic) states of these materials. In his presentation, Dr. Lebby explained that these materials are poled into a metastable state in order to activate their data-carrying characteristics. The data confirmed that the engineering of the new material resulted in higher stability.
Great article, zig zag. I don't recall if it was posted earlier or not. New investors in particular should read the whole thing (only part is quoted). It provides a good summary of the business model being used to move the devices from the demonstration phase to "mass commercialization" (love that quote). LWLG is using feedback from NDA partners to not only improve performance, but to fine-tune the tech for ease of manufacturing, which will ease the process of integration.
Note that the article is from December 6, 2000, so more information has become available which provides additional optimism.
I'm still wondering if LWLG has faster modulators available, but can't announce them because of the limitations of the test equipment.
Thanks, Walter - a great read. I try to explain LWLG to others and it's hard to do. A common question is "if their stuff is so great why doesn't everyone know about it?". As your friend explained, it is a paradigm shift for many in the industry due to the long reliance on current technology, and previous lack of progress with polymers. Now, tech investors and industry experts are starting to see the value of LWLG. This is not a fad or meme stock.
Your point is valid. However, if you read all of the rule and look at the table, it becomes very confusing. The three asterisks on the table seem to only apply to the $2 closing price. I'm not trying to argue one way or another, just trying to understand what the rules actually say.
I've had a long career as a consulting environmental engineer, mostly dealing in the cleanup and disposal of waste materials. Deciphering local, state and federal regulations is a unpleasant part of the business. There always seem to be contradictions and the language is too open to interpretation.
I learned 2 things about regulations: 1. Ask the regulator what it is they actually require. 2. Never ask a lawyer - they will confuse things even more.
I have searched for any statement in the listing rules regarding the 90 day requirement and can't find it. I am curious as to it's origin.
The applicable rules for the Capital Market are here: here.
The table that has been posted refers to rules sections 5505(a)and, for the market value standard, 5505(b)(2).
Section 5505(a) states (bold emphasis is mine):
A Company applying to list its Primary Equity Security on the Capital Market must meet all of the requirements set forth in Rule 5505(a) and at least one of the Standards in Rule 5505(b).
(a) Initial Listing Requirements for Primary Equity Securities:
(1) (A) Minimum bid price of $4 per share; or
(B) Minimum closing price of $3 per share, if the Company meets the requirements of the Equity or Net Income Standards under Rules 5505(b)(1) or (b)(3), or of $2 per share, if the Company meets the requirements of the Market Value of Listed Securities Standard under Rule 5505(b)(2), provided that in either case the Company must also demonstrate that it has net tangible assets (i.e., total assets less intangible assets and liabilities) in excess of $2 million, if the issuer has been in continuous operation for at least three years; or net tangible assets in excess of $5 million, if the issuer has been in continuous operation for less than three years; or average revenue of at least $6 million for the last three years. A security must meet the applicable closing price requirement for at least five consecutive business days prior to approval.
For purposes of this paragraph (B), net tangible assets or average revenues must be demonstrated on the Company's most recently filed audited financial statements filed with, and satisfying the requirements of, the Commission or Other Regulatory Authority, and which are dated less than 15 months prior to the date of listing.
(2) At least 1,000,000 Unrestricted Publicly Held Shares;
(3) (i) At least 300 Round Lot Holders; and (ii) at least 50% of such Round Lot Holders must each hold Unrestricted Securities with a Market Value of at least $2,500; provided that (ii) shall not apply to a Company whose business plan is to complete one or more acquisitions, as described in IM-5101-2;
(4) At least three registered and active Market Makers;
(5) If the security is trading in the U.S. over-the-counter as of the date of application, such security must have a minimum average daily trading volume of 2,000 shares over the 30 trading day period prior to listing (including trading volume of the underlying security on the primary market with respect to an ADR), with trading occurring on more than half of those 30 days, unless such security is listed on the Exchange in connection with a firm commitment underwritten public offering of at least $4 million; and
(6) In the case of ADRs, at least 400,000 issued.
Thanks for posting this. Could you clarify what '3dB bandwidth' means in this context?
Also, is LWLG unable to announce faster speeds for their devices due to the limitations of the testing equipment?
Thanks.
Two questions: 1. What does "3dB optical bandwidths" refer to?
2. Is LWLG being limited from announcing even higher speed devices because of the limitations of the testing equipment?
Thx
I also invested based on information I read on the Silicon Investor board, much of it from the esteemed Mr. Grobbel.
First purchase was in June 2006 when the Univ. of Arizona confirmed the 'goo' actually worked.
You beat me by a couple of minutes!
Only a bid of $4 is required, not a close (doesn't matter, that hurdle has been cleared).
The review process can be "considerably" less than 4-6 weeks.
Look at the linked document. Many questions will be answered. It's pretty straightforward.
Got tired of people bickering about NASDAQ listing. Google is your friend!
NASDAQ Initial Listing Guide
This link is for the NASDAQ guide for listing applications. Note:
While it generally takes four to six weeks to process a listing application, this time frame is variable and maybe shortened considerably, if the application raises no issues and the company responds quickly to Staff comments.
Minimum bid price of $4 per share
Since we are able to gather much of the information needed to verify compliance from publicly available sources, the forms and supporting documentation you need to apply to Nasdaq should take only a short time to prepare.
Preliminary financial results released
www.capitalcube.com/blog/index.php/ctd-holdings-inc-earnings-q2-2015/
Don't think I've seen them do this before.
You cited IBM's announcement in post 15688 (credit to you). I didn't read the article you linked at that time. It is notable how the language in all these articles correlates to LWLG statements.
Here is more info on IBM's announcement: http://www.eetimes.com/document.asp?doc_id=1326576
These articles read a lot like a LWLG PR. If we are not involved, is there any reason to hold?
The article doesn't link to source for the announcement, so I'm not sure if this is new news or not. IBM didn't release PR about this that I've seen.
IBM announces silicon photonics breakthrough, set to break 100Gb/s barrier.
http://www.extremetech.com/extreme/205713-ibm-announces-silicon-photonics-breakthrough-set-to-break-100gbs-barrier
Anyone want to comment on this?
Phase 3 protocol posted on Clinicaltrials.gov
New CTD post has the link. http://clinicaltrials.gov/ct2/show/NCT02288897?term=provectus&recr=Open&rank=2
Why is the study limited to patients with no more than 20 lesions? Also confused by the reference to 25 lesions ("Subjects will receive intralesional PV-10 to all Study Lesions on study Day 1. PV-10 should be re-administered at Day 29 (Week 5) and/or Day 57 (Week 9) for treatment of any existing disease on the skin (not exceeding 25 Study Lesions) and thereafter at 28-day intervals until complete response, disease progression or study termination occurs.")
What does he mean by "combining PV-10 to treat patients with disease inaccessible to direct injections"? How would that work?
Two things I noticed in the overview under Item 2. One, they mentioned photovoltaic cells as an example market. Not power or power storage, as in the April 8 (Corning) PR.
Two, they mentioned "two new material systems which have demonstrated outstanding electro-optic values", but not Malachite.
Not sure if these are significant, but I found them curious.
I didn't see any mention of new patents filings, but I didnt' go through the whole report.
Vorlon - is the study more open because the ECOG status is 0 - 3 compared to 0 - 2 previously?
What makes the data reportable? I don't see it.
Thanks.
If you are referring to post 12459, X said he hopes they hold whatever news until the ASM. I don't see that as a hint that there is some big news being kept under wraps. He seems to be leaning toward an acquisition, but if an agreement is reached, that would be material and unless it happens right before the ASM, they have to release it separately. Also, please explain the rationale for withholding positive news. If it's general excitement and expectations, then we just heard about it.
In my experience, ASMs are not the venue for breaking big news. During the presentation and Q&A we get a few tidbits that clarify a few things, but not much different from the letter.
Nice summary, KCCO. For my first post on the board (I go back to the SI board and have owned stock for many years), I want to compare the December 2013 update to this one. The list is items mentioned in December and what was said today:
Provisional patents (no mention)
SLM timeline - "We intend to put forth a timeline on this project after it is fully vetted". (No timeline provided - barely mentioned.)
MINTS - "we expect to have initial proof of concept devices available for testing in late Q1 2014.... The next run will be coated with our polymer materials, which is slated for late Q2 2014." (slowed by delayed delivery of wafers by OPSIS and IMEC.)
Slot waveguide structures - "With wafers provided by IMEC...", so they had wafers for these in 2013. I assume these are components that will be included on the forthcoming wafers from OPSIS and IMEC.
Advanced telecom modulator - "...we have decided to move it forward into the initial prototype phase. The first step here is to bring online the necessary manufacturing capacity in order to support the fabrication of the device." (Not sure how the bleached modulated fits here, but that is waiting for the clean room, which they are just starting to build out. For the slot waveguide modulator "We have already successfully demonstrated this basic building block of photonic devices and are now getting ready to repeat this with new materials and expect a series of results throughout the year." So we continue to wait.)
All optical switch - "We currently have an all-optical circuit design with waveguides. These are now available to us, and initial testing should be complete in the first half of 2014." ("We expect initial results for this application in the late summer, early fall." Again, we wait.)
LSS - not mentioned in the new update.
3-way collaboration - not mentioned.
There are a few new things mentioned in today's update, but I don't see how they or the "recent successes we have achieved in polymer material science" create much excitement. They have had many "successes" in the past (new materials, etc.) but still no device. Also, no discussion of revenues. All in all, I don't share their excitement. If they "tinker around" for another year with no device and confirmed results to show for it, we're dead.
See the latest CTD blog post.
http://provectuspharmaceuticalsinc.blogspot.com/
The lawsuit against the officers, the lack of progress over the past few years. Some uncertainty with the financing. The way they handled the publicity regarding the BTD decision.
The FDA mention of the concerns raised in past meetings didn't help either. The impression is that there is a disconnect between the company and the FDA.
Much of this is a matter of perception, but it's left the company open to criticism.
The irony is that the publicity prior to the BTD decision raised the share price, which led to warrants being cashed in, which brought a lot of cash into the coffers. Maybe they are crazy like a fox.
I'll take an uneducated guess. Remember the old saying "any publicity is good publicity"? I think both management and, unwittingly, the bashers, have raised the profile of the stock. This is a small company with a novel drug candidate that is going it alone, making slow progress, and it was under the radar prior to December. It's still rarely mentioned in discussions of up-and-coming melanoma therapies, despite the data and safety profile. I have no idea how serious big pharma was taking them prior to December, but the new advisory board appointments have to have opened some eyes. I think also, despite the fog of negativity, investors are seeing what's really there. ASCO may not have swayed the FDA, but Moffitt and Dr. Weber are making a difference. The evidence is mounting and it's all good. The move to a better exchange is helping, too. If institutions are buying in, even better.
There are negatives, too, but more people are seeing a risk worth taking.
I have the same concerns about the study, too, the restricted study population, etc., based on what's been said so far. I am not educated enough understand the implications, so I'll wait until the CC, where hopefully the study details will be clarified.
Maybe PVCT is not concerned about narrowing the market initially, and just want to get approval via the easiest path by giving the FDA what it wants, and will work to expand the market later?
Somebody (Vorlon?) said AF, to attack PV-10 now, would have to "stare down" the best researchers in the world. He's doing that by ignoring the conclusions Moffitt (including Dr. Weber) has drawn from their data as presented at ASCO. Is it delusional to believe the data, and Dr. Weber's quotes? I don't think so, and I want to believe that is why the short attack is not holding up.
A bit of information that has not been discussed - Moffitt said that work is already underway to establish the interaction of PV-10 with checkpoint inhibitors. There is an extensive blog post from June 7 about this and other work regarding combinations. This work can open a second avenue for approval, beyond the Phase 3.
It doesn't matter what the "4 guys in a barn" are doing in their lab, or what AF thinks of them personally. They hired Moffitt to figure out how PV-10 works, and so far they've proven it does work and that it activates the immune system. The only glitch is that they couldn't get more data because PV-10 killed all the tumor cells too quickly. If FDA is listening to the leading experts, they have to come around, sooner or later.
Conference call next Thursday per PR (http://finance.yahoo.com/news/provectus-biopharmaceuticals-discuss-outline-phase-100000932.html).
In addition to discussing the Phase 3 trial, they will discuss "...potential plans to monetize its PV-10 and PH-10 assets with various contemplated license and co-development transactions".
Could be very interesting.
They must be looking to incorporate a Special Protocol Assessment (SPA) to address the specific clinical benefit endpoints (pain, infection, bleeding) to help speed the process along. They discussed SPA with the FDA in the October 2011 meeting (per the transcript from the CC). I assume they'd have to re-negotiate the protocol, however.
The FDA letter said "You may submit a new request if you obtain new clinical evidence that PV-10 demonstrates a substantial improvement over existing therapies on one or more clinically significant endpoints in the treatment of locally advanced cutaneous melanoma." Does "one or more" mean they only have to demonstrate improvement in, say, pain, or is pain-infection-bleeding one endpoint?
IMO, there should be a PR. Moffitt presented at AACR in April and information was included in a PR on April 7, but not all the data was included. The blogger had 2 slides on his site that he took down due to ASCO restriction, which is over now that the presentation has been made. Not sure if there is new data in Agarwala's presentation that hasn't been PR'd yet.
Here is the ASCO policy on releasing information in the abstracts. I take it to mean that once presented, it can be released (I can be wrong, tho).
Submitted abstracts are considered both CONFIDENTIAL and EMBARGOED from the time of submission. Prior to the information being publicly released in conjunction with the ASCO Annual Meeting, the author, coauthors, and sponsor of the research, journalists, and others may not
* make the information public, or provide it to others who may make it public (such as news media),
* publish or present the information or provide it to others who may publish or present it, or
* use the information for trading in the securities of any issuer, or provide it to others who may use it for securities trading purposes.
Now that the presentations are available as ASCO, there should be a PR to discuss all the data before the CC.
How do you "demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints". The blogger addressed this (http://provectuspharmaceuticalsinc.blogspot.com/p/blog-news-items.html), but the discussion is over my head.
This lays out the standard of care for each stage: http://www.cancer.org/cancer/skincancer-melanoma/detailedguide/melanoma-skin-cancer-treating-by-stage
There are many treatment options available for stages 3, 4 and for recurrent. Does PV-10 have to be better than all of them? How do you prove it? Is is as simple as demonstrating improvement in pain, bleeding, etc., or does it have to be compared to all options? How difficult will this be? I'd like to hear some ideas as to how this will be done. The CC nest week should address some of these questions, but I assume they won't have the trial design completed by then.
Thanks to Mr. Ross for going to the source. The Q&A and the transcript from the CC show that (to me, anyway) that the FDA had concerns all along regarding a number of issues with the studies, and that management was trying to get agreement on the patient populations, end points, etc., but the process was dragging on until the Dec. 2013 meeting. Now, the endpoints are clear, but unfortunately that data isn't available to prove them to the FDA's satisfaction. This quote from Wachter "We believe complete response is tantamount to eliminating the physical or psychological symptoms of melanoma of the skin, but the denial of the request and the wording of the denial letter show this message was not successfully communicated." supports this. I still feel management should have recognized this as a problem and either worked more with FDA to get them to agree to this approach or just moved ahead with further study. The FDA could have been more open-minded about this, also.
Anyway, all bashing and trashing aside, the way ahead "very likely has to be an additional study to collect more information to conclusively establish the link between complete response (tumor ablation) and symptom control." (quoted from the latest blog post - http://provectuspharmaceuticalsinc.blogspot.com/p/blog-news-items.html). Hopefully, this can be done quickly.
I don't think the were doing anything contrary to what the FDA wanted. It sounds like they tried to provide the data. I just think they should have recognized they were short and taken a different approach.
Again, in my experience with different regulators in a different field, when we know we can't readily give them what they want, you either come up with alternate approach (and convince the regulators that it is valid prior to submitting it) or go get them what they want (which takes more time and money and clients don't want to do, but sometimes have to). They tried a different approach but didn't know if the FDA would buy it. Kind of like an attorney asking a question in court and not knowing what the witness will say.
I also find it odd that the FDA asked for information that they knew PVCT didn't have. Maybe I'm misreading what happened, but looks like "failure to communicate".
I'm not defending anyone, I'm just saying I've seen it happen. The letter was signed on the 16th, but postmarked on the 20th. What is of utmost importance to some is just routine business to others.
The letter was signed May 16. From my experience (not with FDA), you deal with certain staffers, but a decision like this is signed by someone a couple of rungs higher on the ladder and it may not get back to the staff's desks right away. He said the letter was postmarked May 20. Typically, the staff sends an electronic version, but he said that didn't happened until the 21st when he called them. The FDA was still within the 60 day deadline so there may not have been any urgency at that point.
It is very unlikely that Dees (in the PR) or Wachter is lying about this. I've seen how easily lawyers can legally obtain the email records from various parties. A suit doesn't have to be filed - the proper request just has to be filed. It would be very easy to prove they were lying, and they must know that.
Which leads back to AF and what he knew and when.