bummer of timing for that statement. ugh now if i was zsan id have a call tomorrow before bell to explain the way fwd

https://www.fda.gov/media/109961/download#:~:text=Discipline%20review%20letter%20(DRL)%20%E2%80%93,conclusion%20of%20the%20discipline%20review.

This video is from 2019... stop posting BS...


"""
Nice interview. Could be the spark we need here.
http://www.bnnbloomberg.ca/investing/video/alex-ruus-discusses-acasti-pharma~1479720

No reference to Acasti in your article, no relationship with Merck..read more slowly..

" In December 2017, Merck signed a Distribution Agreement with Avanti Polar Lipids. Avanti Polar Lipids is a leading producer and supplier of the highest purity lipids for research and pharmaceutical product development

Depends on context:

Memorandum of Agreement (MOA) but for biotechs / pharma could be:

In pharmacology, the term mechanism of action (MOA) refers to the specific biochemical interaction through which a drug substance produces its pharmacological effect. A mechanism of action usually includes mention of the specific molecular targets to which the drug binds, such as an enzyme or

Heat isnt necessarily the key reason
https://ccdd.hsph.harvard.edu/will-covid-19-go-away-on-its-own-in-warmer-weather/

Factor 1: The environment.
In the winter, the outdoor air is colder, and the air is dryer usually both indoors and out. For influenza, it has been elegantly shown in the lab that absolute humidity — the quantity of water vapor in the air — strongly affects flu transmission, with drier conditions being more favorable. Subsequently it has been shown that epidemiological patterns are consistent with this lab data in the US and in Vietnam, among other study sites. Notably the Vietnam study looked at influenza-like illness, without distinguishing influenza from other types of pathogens. This hints that similar mechanisms may be at work for other respiratory viruses, but to my knowledge are no specific studies of the role of humidity for coronaviruses or other respiratory viruses besides flu. Also important: there may be some very humid conditions that also favor flu transmission, especially relevant in the tropics. Still it is safe to say that in temperate countries, dry cold air = favorable conditions for flu transmission. For coronaviruses, the relevance of this factor is unknown. A recent preprint on which I collaborated suggests that transmission is possible in many different climates, and points out that Singapore, for example, which lies nearly on the equator, has had significant transmission. This is one piece of evidence, but as my colleague Dr. Eli Perencevich has pointed out there are many differences between Singapore in February and a temperate zone in summer — different day length, ultraviolet radiation, and other factors that may be important for coronavirus – we simply don’t know.

not sure why a BP couldnt do a deal in next few months if PH2B results are stellar. It's analyzing data (thrown into a secure dataroom that Antibe would load) that dd takes 30-60 days and by then the BP would have all they need to know if they want to buy regardless of this pandemic.... now is the time for companies cash flush to deploy it esp for a small bo like this one would be $500m - $1b

$1b USD would be about $2.81 per share if you use fully dilluted share count / rsus / warrants of 356M shares

Doubt it is delayed, last patients were enrolled in end of Feb per their PR and treatment is 2 weeks with 2 week follow up. Usually studies can cut the remaining patients if the have hit the statistical confidence needed..
I also think if they do not announce a delay by this week it is a sign things are all go for better or worse...

I think a $500M MC is feasible if PH2B is solid, i used 356m shares with full diluted based on corp presentation slide 25. My one disappointment with this company is this share count. Way too many shares esp warrants.

Share Price(1) $0.375
Shares Outstanding 274M
Stock Options & RSUs 36M
Warrants 46M
Market Capitalization(1) $103M
Cash & Equivalents(2) $11M
Insider Ownership FULLY DILUTED 18%
Annual Sales(3) $10M

http://www.antibethera.com/wordpress/pdf/presentations/Antibe%20Investor%20Presentation%20-%20September%202019.pdf


1,000,000,000
MC $B 0.5
MC $500,000,000
Shares Outstanding 356,000,000
PPS $1.40
274,000,000

UFO - valuation could take off if secondary endpoints (reported in March) but without these or one of them hitting I do not think ACST will see a MC above $1B / $10PPS (est 104M shares outstanding) based on the saturated-highly competitive landscape in the high trig market (500+) / unless they expand to China quickly. Thoughts on when your $40 could hit?


Secondly, we want to report out results on non-HDL-cholesterol, then followed by VLDL and then HDL, and then finally, LDL and hemoglobin A1c. It's important to note that the TRILOGY protocol requires our physician investigators to determine if patients who presented at screening with high LDL and/or high hemoglobin A1c levels, be put on standard therapies such as statins or short-acting diabetes meds. If so, those patients had to show that their LDL and hemoglobin A1c levels had stabilized prior to being randomized into the TRILOGY study. Therefore, we hope to show any incremental benefited CaPre above and beyond the standard of care. The results with both LDL and hemoglobin A1c will require subgroup analyses, which will be done by combining CaPre results from diabetic patients and separately CaPre results from patients with high LDL from both studies to reach adequate statistical power to detect the difference from the respective placebo groups, if one exist.

Now Acasti expects that the remaining numerous secondary and exploratory endpoints along with various additional subgroup analyses should be completed before the end of March 2020. In addition to our preliminary top line data, we'll seek to present the full data set, which will include results for all of our key secondary and exploratory endpoints of interest such as non-HDL, VLDL, HDL, LDL-cholesterol and hemoglobin A1c and others. And we plan to present these at key scientific meetings in the first half of 2020, potentially including the American College of Cardiology in March, the National Lipid Association in May and the American Diabetes Association in June. We plan to communicate more information in the months ahead on how and when all of the TRILOGY results will be reported once the statistical analysis plan is finalized.

CDrucker - previous phase 2 covered a lower range (under 500) , phase 3 is geared towards Very high (500 mg/dL or higher). In regards to expanded label I'd guess they'd need to run another trial (hopefully not an outcome like AMRN had to do for their upcoming Dec FDA Adcom) and then apply for expanded label). The high trig population in US is (from what I remember) 3 million to 6 million but china opportunity is huge (see below for 4Q call)

"I thought I would point out some key differences and advantages to the design of our TRILOGY studies as compared to our Phase 2 program. As I mentioned, we expect a total of approximately 500 patients to complete the two TRILOGY studies. And there are significant differences in the clinical profile of these patients compared to those who completed our Phase 2 studies."
https://seekingalpha.com/article/4272297-acasti-pharma-inc-acst-ceo-jan-dalvise-q4-2019-results-earnings-call-transcript

"China is actually the third largest pharmaceutical market in the world with an average compounded annual sales growth rate of approximately 20% over the last 10 years. In addition let me remind you that China represents an important market for Acasti given the high prevalence of hypertriglyceridemia and the need for an effective safe and efficiently absorbed drug for the treatment of cardiometabolic related diseases"




In the new report, Earl S. Ford, MD, of the CDC, and his colleagues looked at a nationally representative group of 5,610 people 20 and older. They found that 33.1% had triglyceride levels above 150 mg/dL, while 17.9% had levels above 200 mg/dL, 1.7% had levels of 500 mg/dL or above, and 0.4% had levels higher than 1,000 mg/dL
https://www.health.com/cholesterol/americans-high-triglycerides


Approximately one-third of the US population has elevations in circulating triglyceride levels [1, 2]. Most of these elevations are mild to moderate in nature, and the pathophysiology involves hepatic overproduction of very low?density lipoproteins (VLDLs), the principal triglyceride-carrying lipoprotein circulating in the fasting state [3, 4]. A subset of patients have “very severe hypertriglyceridemia,” defined by the Endocrine Society as serum triglyceride concentration ≥2000 mg/dL (22.6 mmol/L) [5]. In addition to VLDL overproduction, the pathophysiology of very severe hypertriglyceridemia involves defective triglyceride clearance due to either saturation or dysfunction of the enzyme lipoprotein lipase (LPL), resulting in accumulation of chylomicrons and VLDLs [3, 6, 7].

https://consumer.healthday.com/circulatory-system-information-7/blood-disorder-news-68/americans-blood-triglyceride-levels-dropping-cdc-699187.html

Subs - glad to hear, I didnt sell on last run as I thought they finally had it together. Sold at break even / minor loss.

ARWR has made that loss back. Like I said might come back if some signs of life occur.
Good luck to you!

sorry mate... sucks. silver lining is if as mentioned here that this is a prereq for a large contract

It is still VA and an old customer which concerns me they cannot break into large private sector accounts (aside from small Fujitsu and CDW wins)..

Appears to to be contention of existing VA support, not Goverify

Hopefully it doesn't but I am reducing my position and if the co. signs some contracts with real revenues I will wade back in. I spent to much time on hope, not reality with this co./stock. Good luck to you!

http://wsw.com/webcast/ldmicro14/iwsy/

Presentation and audio from conference today

Watching paint dry....

Miller and team at least are consistent with not meeting any expectations / not reaching any deals

Blackpearl2004 - on last call someone asked this question on competition -

https://finance.yahoo.com/news/edited-transcript-iwsy-earnings-conference-034643061.html

Okay, last one. Can you give us an update on the competitive landscape? In your opinion, are there any competitors that are moving towards a multi-modal cloud-based storage platform like you guys?

--------------------------------------------------------------------------------

S. James Miller, ImageWare Systems, Inc. - Chairman & CEO [9]

--------------------------------------------------------------------------------

There's a lot of, as I said before, there is lot of noise in the space, there continues to be. It's pretty easy for people to say we do the same thing that ImageWare does. When you scrape the paint away, and the noise away, and get right down to it, the fact is they don't. There are a number of companies that are truly professional service companies. They're not product companies. We are a product company. That is, I know, you know, a huge distinction. We've worked long and hard so that we sell the same product over and over again. We are not custom building individual products every time out. That's a big difference and there is a lot of folks who despite what they say, that is in fact what they do. And so they are supporting custom one-offs all the way through. There are other folks that just supply tools. Here you can build your own. That's an idea. It's an approach for sure. I can tell you from having tried that ourselves once upon a time. Even large global companies with very sophisticated capable IT groups do not want to work hard at integration, do not want to work hard at developing a product that they are not as familiar with as you. They prefer to have the product dropped and integrated with little or no time and little or no coding, which we provide. And that -- those things continue to be things that ImageWare does better than anything we have seen in the market today. So again, there is a fair amount of noise that's out there, but in terms of cloud-based platforms, no. We have not seen anything that does what we do.

WCN - MicroCap,

I anticipated that sales would be driven by Fujitsu outside their Federated Id Mgmt platform and 1-2 deals would come through by now from their general Biometrics-as-a-Service (not connected to the Fed platform). Fujitsu has had a long runway on Baas that it seemed plausible that some bookings would have occurred by now.

Still waiting on a moderate size deal (+ $1m) to show traction with one of the partners and validate that IWS has a product that large enterprise customers see value in / putting their capital towards. Aren't we all....

Agree. I listened to and read the transcript.

Call it what you may but this company cannot execute.

Only reason I will stick around is Fujitsu. I have believe they will eventually succeed in some medium sized contract.

i'd like to see the stock hit the $1.40 or below to potentially add to the position. I have faith in Fujitsu...

What is your timeline guess when IWS would be bought out?

If IWS can hit breakeven this year I'd prefer for them to ramp up revenue in 2019 (avoid being acquired until 2020) so the premium a buyer has to pay is related to IWS revenues in the 100s of millions.. That is a long time off.


Why IBM and not Fujitsu as they have had deepest relationship?

Although low volume, nice to see yesterday's PR lift the stock.

Slow start but helpful to get some traction and add to real life examples that can drive future sales.

With the partner network if one large sale hits this will drive other sales execs to see the promise of the offering... Sales teams are like sharks, once they smell blood in the water (large contract) they become aggressive to get their own meal....

Still slow, but it is something.. Let's see if by May IWS can lock down something news worthy. $1M-2M new contract....

We need an active board and currently most of the board appear disengaged. I've emailed / LinkedIn and left VMs or spoke to many over the last two years.

Recommend other investors (some already have stated they have made contact) contact the members of the board. One last ditch effort to make them wake up...

Dana W. Kammersgard 60 - Seagate Exec VP --- LinkedIn contact available
Neal Goldman - 72 - Goldman Capital Management (212) 676-5571 ngoldman@goldmancap.com
John Cronin - Age Unk (late 60's early 70's - IP Capital group (888) 853-2212 - type in his name in co. directory and you can leave a message, posted article below. JCronin@ipcg.com
Charles Crocker - 77 - still runs Crocker Capital - 415-956 - 5250
Guy Steve Hamm - 69 - Appears he retired in 2006 - no evidence he is working /active
David Loesch - 72 - He retired in 2001 from FBI - no contact info

The more they hear the same message maybe they will actually do something...then again.

see yahoo mb - poster CS knows his stuff...


"'CS wrote:
Fujitsu is a reseller for Nok Nok Labs in Japan. I posted the announcement of this last summer (June?) so it's no surprise. NNL is one of the founding entities and drivers behind the FIDO Alliance. I have yet to see anything out of Fujitsu Japan or APAC regarding IWS and BIOaaS, which is their branded service oriented product, despite what Miller says is pending. Fujitsu has a long history of involvement in biometrics. They had a fingerprint sensor on their Arrow phone for their home market long before Apple ever thought of it, developed proprietary PalmSecure sensors and several matching algorithms, and have acted as system integrator for various government/ national security programs. They have and do operate in multiple domains. That's not an issue, putting real marketing muscle behind multiple use cases for BIOaaS, in multiple geographical regions, is."""

For those that believe IWS has a shot price drop will continue and allow you to load up.
Would not be surprised if it heads back to $1.20's...

microcaptrdr24 - you out there? thoughts on Fujitsu Fed ID mgmt project stall. Are you still in or did you sell to lock in profits?

no worries! Welcome to the board, new perspective with insights/different angle helps.

I for one have been too focused on IWS inability to secure a deal and separating that from actual partner ability (now integration/training completed) is required. Still not convinced anything will occur but CDW and Fujitsu are capable partners.

What is your thought on Fujitsu having to refine the proof of concept for the federated identity system? That to me is disconcerting that they had to go back to the drawing board...



"Fujitsu originally announced that project to commence late Q3 2017. They're currently working on refining a proof of concept and their updated timeline calls for sales deployments in the summer of 2018. We continue to anticipate that the federated management opportunity will have a significant positive impact on our company. As in any large project you and we have ever seen these wheels turn slowly and I look forward to providing updates over the course of the year in future calls.

Lowcountry15

Appreciate the rationale to the approach you have with IWS. I'd agree that Fujitsu is the real deal, just curious why they didn't use IWSY on UK contract?

What is your thought ob capital raise and whether IWSY hits breakeven this calendar year (not the first time they have stated this).

Hopefully this pick will work out for us as well as it did for Straight Path :)

IWSY is finding it more difficult to source capital to keep the lights on. They run out of capital Q3 - AUG/Sept based on EOY report and burn rate that has been relatively steady for years...

I don't get how they can ramp up without a miracle (this is it below and we are at a 5% shot IMO).


"Wayne Wetherell

We need somewhere between 4.5 million and 5 million on a quarterly basis. However, there is an interesting trend in this particular market, but we are up-signed to large customers or when Fujitsu or partners are out selling to large customers, we are finding that many of them are more interested in purchasing a block of identities for a period of time, be it one year, two years, maybe even three years. This in turn allows us to bill for a one-year, two-year period in advance and gain acceleration on the cash flow, sometimes ahead of the revenue. If that customer is using our service, in other words, we are hosting the service, then that is a service we are providing. Even if we get paid upfront we will have to recognize that revenue over the duration of that contract. If the customer is going to put this on their web service, they are basically licensing our product. We will be able to recognize both the revenue and have the cash up front. So, it’s an interesting thing that’s going to impact our cash flow and we think favorably. "



https://seekingalpha.com/article/4157797-imageware-systems-iwsy-ceo-jim-miller-q4-2017-results-earnings-call-transcript


Fujitsu originally announced that project to commence late Q3 2017. They're currently working on refining a proof of concept and their updated timeline calls for sales deployments in the summer of 2018. We continue to anticipate that the federated management opportunity will have a significant positive impact on our company. As in any large project you and we have ever seen these wheels turn slowly and I look forward to providing updates over the course of the year in future calls.

Investors and speculators were holding / buying a stock as many likely were waiting on a possible Fujitsu Federated deal to jump start revenues.

Now that this is pushed back at the earliest Q3 - the stock will not be holding up, unless there is a surprise revenue deal...

Year End Call Highlights (more like low lights...) the pain continues....with no near term Fujitsu Id Federated project anytime soon - and no mention of Fujitsu UK ... stock will be in free fall sooner than later..

-- Fujitsu -
- Med click (IWS pillphone) - per user price point may be higher (TBD). No sales to report.
- Federated Mgmt ID project - Fujitsu refining proof of concept and sales deployment now pushed out to summer 2018- originally scheduled to start Q3.

-- CDW - small initial revenues are coming in. IWS has a based sales employee based in Chi at CDW who works daily with CDW to educate, address issues, support, .

-- IBM ISAM - ramp Q2/Q3 - doesnt sound like IBM will support this aside from what Miller said were introductions -

-- HPE’s Aruba ClearPass - no sig movement to report

-- SAP - working with new program to accelerate resale of their product .. no specifics to note

-- No other partners mentioned

--Internal
Now have VP R. Brown working on alliances
Hired new exec for Sales strategy sole focus (from what I heard)
Asia Pacific - sales exec hired for day to day with Fujitsu and other corps in region

MicroCap-

YR end call confirmed no revenues from Fujitsu yet... unreal...

also hate to be right about this but Fujitsu Federated Partnership has not started...

Fujitsu - Federated Mgmt ID project - Refining proof of concept and sales deployment pushed out to summer 2018- originally scheduled to start Q3

This is why I don't believe it until I see it reflected in the books. Esp if it comes from Miller of course I assumed Fujitsu would be more apt to hit a targeted start date but...

I expect stock to trace back now fully

Chaka did you read it?

It's more of the same, no significant revenue, now Q2, once again Miller is Miller....


I don't see this happening based on current no news...

"We are fully funded to cash flow breakeven later this year"

At $0.50 cents/ user/ month/ that requires ~2.5-2.75 million enrolled users. It's the middle of March, and Delay still can't name that Mythical Fist Subscriber.

Highly recommend listening to Miller talk during the Roth conference today.

Highlights -

Slide 3 - no Tranunion or deutsche telekom logos in GTM partnerships

Slide 4 & 10 -CDW first sales have occurred - no sales reported with Fujtsu and IBM yet....

Slide 10 - revenue per user per month is between $0.25 - $0.75

slide 15 - Fully funded to reach cash flow positive later this year (sure Miller...). Expect to apply for an uplisting to a major exchange this summer

ImageWare Systems to Present at the 30th Annual ROTH Capital Partners Conference

http://wsw.com/webcast/roth32/iwsy/index.aspx

https://iwsinc.com/2018/02/26/imageware-present-30th-annual-roth-capital-partners-conference/

I read it a different way, that Fujitsu and CDW have started sales efforts - past sales enablement and to full GTM execution. I am more than happy to be wrong on my glass half empty view ;)




"Fujitsu – initiated sales efforts for GoVerifyID®
IBM – validated GoVerifyID to integrate with IBM’s ISAM (Security Access Manager)
CDW – initiated sales for GoVerifyID and IWS Cloud ID solutions

which partner are you referring to? Fujitsu? Any color Miller provides would be helpful to see if breakeven if even close to possible in FY18

I hope so, Im going to be skeptical until the end... no trust in Miller but once I see the facts in printed word in a PR with rev figures attached and later booked in the financials next qtr or qtr after I will believe IWS has turned a corner...

Even a small rev PR prior to qtr cc would be helpful..