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AgeX sold at $2.50 a share.
We now seem to have Jim Mellon's stamp of approval and access to TWO Artificial Intelligence platforms to hopefully expedite and provide more efficacy to our research process.
There's abundant evidence of poor human decision making in the biotech world that I'm inclined to approve of the addition of machine intelligence decision making to the AgeX process.
Nowhere does it say anything about a topical application for the heart.
Topical is mentioned, yes, but you are ignoring the quote..."subsequently initiate three clinical trials of cell- and drug-based therapies, each targeting large unmet needs in age-related medicine.
We know that part of the Renelon process involves an already FDA approved product (but we don't know what or how many different formats that product may assume.)
With three different targets mentioned, it seems significant that after they mention congestive heart failure the next sentence begins with "In addition" and then go on to mention a topical application.
So, it seems to me Renelon has three different targets. Whether they can get the device approval for all three targets or just for the topical application is an open question... I'm hoping the preclinical results point to one of the three (topical) being the most reliable and noteworthy, and if it's a success they could go back for approval of the other two when they have good results with the topical application.
Speculation and dreaming here!!
New information.
Renelon..."initially develop as a topically-administered device" Never saw the "topically-administered" before and I'm glad to see they're going the 501(k) route. If approved in the typical 6 - 12 month time span, there could be some revenue opportunities much earlier than the typical new biotech.
And anyone know the revenue figures for LifeMap or Cytiva?? Never heard of Cytiva before??
John Mauldin named to AgeX BOD. Patrick Cox's newsletter comes out of the Mauldin operation. I believe both Mauldin and Cox bought a number of shares in AgeX when it was being formed as a subsidiary.
Cox's investment advice has a very unimpressive track record. We'll now see if he's more adept when he puts his money where his mouth is??
Any prediction when AgeX spinoff takes place? I thought it was supposed to happen before end of June.
This Korean War veteran tends to disagree. Overall science has proceeded at a pace that humans with their paleolithic emotions and behaviors cannot possibly appreciate the dangers. Two sources supporting my concern.
E. O. Wilson quote
The real problem of humanity is the following: we have paleolithic emotions; medieval institutions; and god-like technology. And it is terrifically dangerous, and it is now approaching a point of crisis overall.
Daniel Kahneman's (Nobel Prize Winner) book THINKING FAST AND SLOW
Demonstrates conclusively how human decision making is severely flawed and unreliable. Artificial intelligence (AI) applications today are highlighting this weakness in so many ways.
And people are saluting the wonders of AI, but if you dig a little deeper and look into where AI is really being researched and developed, it is in DARPA in secret U.S. military budgets, in China military and secret agencies as one of their 10 major initiatives, and I'm sure in Russia, Korea, Iran, and many other crackpot authoritarian regimes. Then research how some of these military types are presenting possible scenarios for future conflict.
This Korean War vet thinks the problem with science is that it doesn't know how to slow down. And then there is the "wisdom" of our political leaders...where power desire replaces intelligence of any kind.
It has been fun to speculate about future strategies for AgeX. Now we wait. First, for distribution date and details surrounding spinoff. Then we wait for the closing date. Then we wait to see the actual proposed sequence of actions surrounding the three areas of focus for AgeX.
If there is no 510(K) application being submitted, my waiting patience for AgeX will be used up.
If there is a 510(K) application subnutted, then we wait some more to see if the FDA approves.
If there is an approval, then we wait to see if they can have an impact in the market(s) selected.
Biotech investing is so much fun.
Of course this is all speculation. You say " to attract investors to fund the development and form good investor base before the spinoff." How about via an IPO or other arrangement connected to the spinoff?
Assuming the distribution date will be set soon (before mid-June), and we know nothing for sure how that's going to be structured...it still is a fact that they are going to need to raise some funds to start implementing their plans for their 3 focused objectives in the Summary slide. Very bluntly, the 510(K) route which could reach APPROVAL in as little as 6 months would draw more funds more quickly than the other two objectives which would have to take many years to gain approval. That is why I'm hoping slide 9 is their opening salvo for more specific information to come coinciding with the time period around the distribution date.
One last time...we're just not communicating well around the 510(K) process. This is a device request. There is no P1, P2, or P3 required. The drug involved has already gone through that drawn out FDA process and gained approval. 510(K) Approval means APPROVAL...go sell it. I'm guessing the 510(K) application will aim at one or two specific markets...Cox mentions scarless healing in cosmetic skin or hair rejuvenation, heart disease, or blindness as possibilities (that's quite a range of markets!) If they achieve success with the first market, they can go back with new 510(K) applications and expand scarless healing into myriad markets.
They freed AST and OCX when they had something going that was already proceeding through the clinic toward well defined goals. Why spinoff AgeX if everything they're focused on has no revenue possibilities for 6-10 years? Wouldn't make sense and would be very difficult to engender money raising enthusiasm.
We agree that Cox is all science, and not a good investment advisor. We also must agree that he's been a long time proponent of BTX.
Anyway, I just reread his article and went through the 20 slides again. Notice the first 8 slides are background also mentioning Opregen and AST. Slide 9 presents the AgeX pipeline including Renelon. And then COX7A1 is highlighted on slides 16-19 and the Summary ends with 3 AgeX focus activities...the last of which is "Therapy designed to induce scarless tissue regeneration."
Six of the last 12 slides deal with "scarless healing." If you're making a strong presentation, don't you highlight your most exciting feature throughout and at the end?
If Cox is right that an artificial intelligence algorithm enabled them to already have found an FDA approved drug that can manipulate COX7A1, and the only delay is to get the patents and other safeguards in place to protect this research from competitors...then the 510(K) route could be ready anytime. Why would they be hyping it (indirectly) if it was 5 years away?
And presumably, as Cox indicates, once the device approval is received, they have a myriad of markets to try out...ranging from scars on damaged hearts to scars on cosmetic surgery!!!
I've seen these device approvals sneak into the market before and if they start showing results, the stock price can explode.
Must take a deep breath now, and let the positive AND negative possibilities percolate for a while. I wish we had a date for the AgeX separation from BTX.
I'm not sure you understand the significance of them listing the 510(k) clearance on the slide. These device approvals can happen in as little as 90 days. Since the drug involved is already FDA approved, they would need no other approval.
If you read Patrick Cox Tech Digest of 1/29/18, you will get a little more information and hear his enthusiasm. He is nearing 80 and is talking about how fast moving this research is and possible to help him in his lifetime.
One man's opinion, of course, but he has pretty good research credentials, even though he's often WAY, WAY early in his enthusiasms.
When AgeX splits off, it will be interesting what info is released about Renelon at that time. Cox is claiming that verifying data on the FDA approved drug's ability to affect the COX7A1 gene is already available, but BTX is waiting to get the patent trail and commercialization/trade secrets established so it will be difficult/impossible to derail the effort. As soon as they start talking about specific plans to go with the 510(k) route, (big question is "how soon") things should become VERY interesting VERY fast.
I'm wondering if anyone else is considering another source of "near term value generating" that might appear in 2018.
If you notice slide 9 of the latest AgeX presentation, it mentions Renelon as a "repurposed drug." The significant entry there might be the mention of the 510(K) Clearance.
I believe Patrick Cox mentioned a while back that the repurposed drug was already FDA approved and if they can get a 510(K) device approval from the FDA, it often takes very little time.
The "scarless healing" category seems possibly purposely ambiguous. If this FDA approved drug has some relationship to the COX7A1 gene as described in the presentation's ending slides, they could be going after a variety of major markets with a 510(K) timeline.
Just a hope and a dream right now, but there are some tea leaves out there that could settle in just the right configuration if we're lucky. Flying under the radar now, but leaving a very tantalizing trail.
Anyone have any stock price predictions when and if AgeX split occurs??
BTX price? AgeX price?
Noticed the Silicon Investor website Biotech Charity Contest where 62 investors choose 8 to 10 biotech stocks based on their expected appreciation during 2018.
http://www.siliconinvestor.com/readmsg.aspx?msgid=31417678
One stock (TRIL) picked by 27 of the 62 investors. 230 stocks mentioned...many mentioned just by 1 or 2 investors. BTX had ZERO mentions. How can this be? How far under the radar does this stock fly? Comments?
Noticed the Silicon Investor website Biotech Charity Contest where 62 investors choose 8 to 10 biotech stocks based on their expected appreciation during 2018.
http://www.siliconinvestor.com/readmsg.aspx?msgid=31417678
One stock (TRIL) picked by 27 of the 62 investors. 230 stocks mentioned...many mentioned just by 1 or 2 investors. INO had ZERO mentions. How can this be? How far under the radar does this stock fly? Comments?
Seems there are companies that are making plans, closing deals, merging, etc.
Cure Pharmaceutical Enters Into Product Development Agreement with Therapix Biosciences To Develop Cannabinoid-Based Product For Sleep Disorders
GlobeNewswire•November 7, 2017
I fail to see how OpRegen can be the "nearest catalyst"?? I'm not going to rehash the last conference call, but it seems the opening comments clearly pointed to the likelihood of Renevia being the lead possibility to affect the share price.
For that matter if the Q1/18 results from AST's spinal study were to be positive and gain more media coverage...and RMAT boost to approval, that could be a tremendous boost to both AST and BTX.
If I'm missing something about OpRegen's likely path to being a near term catalyst, please explain.
11/14/17 OCX CC Highlights
1. No highlights. Delay of commercial launch dates because of "defective consumeables from supplier" (???) postpones validation study....
2. No dates provided for cure to the problem.
3. Very disappointing.
Brief summary of highlights of AST 11/14/17 CC
1. Spinal meeting with FDA by end of Q1/18
2. RMAT designation may include endpoints leading to early FDA approval.
3. Discussions to take advantage of Japan's possibly quicker approval process. Other interested business development inquiries(multiple parties)??
4. Expansion of ongoing spinal study from C5-C7 patients now to include C4-C7.
5. Possibility to find partners for treating other cancers when results of small lung cancer trial results are reported
6. Reducing monthly cash burn from $2M/month to $1.3M/month in 2018
I have no scientific expertise. Is it possible that someone has a way to explain in laymans terms the difference between INO's "dmab" process and ONCS processes titled GENESIS and/or TRACE?
How many other companies are competitors trying to create MABS in vivo? Any websites with comparison information or success analysis available?
Thanks in advance for any info.
I'm way more interested in revenues and the timing and strategies to gain revenue than I am in all these "someday these wonders will appear." Right now the company is focused on Renevia and later OpRegen so that's what I'm "wondering" about. Yes, I know there is an AgeX, and both AST and OCX with possible catalysts to trigger some more revenue opportunities, which "could" impact BTX, but now I'm just wondering about REVENUE in the sequence it might appear for BTX's in house efforts.
We're talking about a $300M market company entering a $30B area which doesn't seem to impress you. There might be some competition for those dollars...and a great deal of marketing and training of dermatologists b4 revenues start to ramp. (People, esp. doctors and dentists don't just change their practices immediately because a company rep hands them some research paper) Again, I'm interested in timing of the arrival of revenue.
I doubt if your quote about Botox which is focused almost entirely on therapuetic uses of Botox (which represents a minimal amount of revenue) rather than aesthetic uses (which represents the most significant revenue) will be too useful for anyone trying to understand the aesthetics marketplace.
If you have some projections about timing of revenues starting to appear or the timing of needed approvals for EU, US, or Asia, I'm all ears.
I agree with most of what you said. Patience is needed, but I like to focus on details...the more the better. Your ending focus on when revenue growth will start is critical. Most interesting part of last CC was the answer to the question about European strategy...
" So in Europe, where we will start with looking at very specifically a European partner, we do have the 2 choices: out-license or distribution partnership. I think my bias would be maybe that a distribution partnership is better. It allows us control. It allows us flexibility. We can get out of it, and then we can choose either to do a larger licensing globally or more licensing regionally. It leaves a lot of flexibility."
We're talking about 2H18 before any ramping of revenue can begin, and then the success and speed of the ramping will rely on good partners...especially those adept at working around the EU, FDA, and Asia bureaucracies.
"Please, Cincinnatus, don't take umbrage at my extravagant verbiage but those who have lived long"
Why should I take umbrage? You didn't really address anything applicable to my "wonderings." Let's simplify this. In my brief research I see the aesthetics market being around $30B and Botox around $6B. I don't really care about backhoes or whatever. I'm wondering about the likelihood that BTX can get a percentage of that $30B or the $6B...and what their strategy is going to be going up against AGN and other large pharmas in this space.
The 2014 FDA approval doesn't seem to have generated much competition for the $30B. What is the pathway in the U.S. or the world to allow BTX to siphon off some of this $30B? Isn't that how investors measure success?
Since I'm 82 years old, your off topic "lived long" tangent was ignored.
Wondering?
If Premvia in U.S. is the same as Renevia in Europe, what hoops will Premvia have to jump through in the U.S. to be approved for aesthetic use? And what would be the timeline? And what would be the success probability against Botox? And will the fact that Premvia is already approved in the U.S. for wound management affect the timeline or maybe some off-label use by dermatologists?
Seriously going after the aesthetics market would seem to imply/require a head to head study vs. Botox at some point. Positive results from such a study would strongly affect negotiations with a large international distributor I would think. Let's get at it...right now.
What positive news?
Someone heard you. Up 31% so far TODAY!!!
At the rate they've been going the last couple of quarters they will not meet the 230 number by the end of the year...which is what they projected.
FMI?? Anyone have any idea why FMI is leaping upward the last few days???
Dilution from Hell!!
With financing stock plus warrants...I think we just went over 2 BILLION shares...back of the envelope approximation. Those tests are going to have to be damn successful...damn fast on that amount of money to maintain the $.02 cent stock price.
Why no NSPH mention in this article?
http://www.wsj.com/articles/new-diagnostic-tools-emerge-in-war-against-superbugs-1447703534
If our leaders can't handle public or media relations, maybe they should consider contracting or hiring. Good science or products don't sell themselves.
"pinned deal"???
What evidence for that? Or just wishful thinking?
Article from practitioner... Be sure to read the ending...
http://www.clpmag.com/2015/11/respiratory-pathogen-testing/?ref=fr-title
" if not it won't ever be from a lack of money."
Curious why you would claim this given their consistently terrible movement toward profitability??
"the delay in the sleep apnea trial (due to NIH bureaucratic meddling) did not cost CORX money so much as time."
Do you have an explanation or a website that gives details about this?
TIA
Relevance of these posts? Basic question seems obvious.
Company had $12.5 million as of Sept. 30, 2014. Average loss per quarter during 2014 for first 3 quarters was about $10 million per quarter. I have seen no press about cutting back on expenses...cutting salaries, closing departments, etc.. Only conclusion??
They're are running a business on fumes and hope rather than money. Can't dilute their way to gain more growth time as share price so low. Very little negotiation leverage. CFO resigning.
What's left? Who's going to buy this poorly managed wounded entity at bargain prices? Who's going to negotiate best deal for shareholders with key people running out the door? And decision time had better be SOON!
janeyH
If you've done government contracting work, what would a GOOD??? sales department have to do to get the product expanding throughout the VA system after making inroads in only one region?
Any high/low estimate of the timeframe a sales department the size of NSPH might shoot for?
Wouldn't you think that this expansion attempt would be a priority item with NSPH leaders?
TIA
65--NOTICE OF INTENT TO SOLE SOURCE TO NANOSPHERE FOR A REAGENT RENTAL AGREEMENT FOR VERIGENE PCR ANALYZERS, INCLUDING ALL EQUIPMENT, SERVICE, SHIPPING AND CONSUMABLES.
Solicitation Number: VA26015Q0114
Agency: Department of Veterans Affairs
Office: VA Northwest Health Network
Location: VA Northwest Health Network
PrintLinkCopy or Bookmark this Page
Copy the url below for a direct link to this page.
Notice DetailsPackagesInterested Vendors ListOpportunity History
Original Synopsis
Nov 19, 2014
12:33 pm
Solicitation Number:
VA26015Q0114 Notice Type:
Special Notice
Synopsis:
Added: Nov 19, 2014 12:33 pm
The Department of Veterans Affairs, NCO 20, in accordance with FAR 13.106-1(b)(2)(single source), intends to negotiate on a sole source Reagent Rental Agreement with Nanosphere for the following products: Targeted Molecular Diagnostic Analyzers (PCR), all consumables and service for Verigene Reader and Processor for the VA Puget Sound and VA Portland Health Care Systems in Seattle, WA 98108 and Portland, OR 97239. Estimated period of performance shall be December 1, 2014 - November 30, 2015 with 2 one-year option periods available. NAICS 325413 applies. This notice of intent is not a solicitation or request for offers. No solicitation package is available. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered. A determination not to compete is solely within the discretion of the Government. Any response to this notice must show clear and convincing evidence that the responding company can provide maintenance, repair and replacement of the HUSH privacy curtains. Responses must be received no later than 4:30 pm on November 28, 2014. All responses must be e-mailed to mona.nimmo@va.gov.
Anyone interested in some fundamental analysis on this board? Surprised that someone hasn't commented about the inroads made in the Northwest into the VA system.
Since the VA has hospitals in every state and multiple locations in many states, this could be very significant if they can expand quickly into many U.S. regions from this initial successful regional contract.
Anyone have historical or inside knowledge of the communication between the various regional VA administrations...concerning the likelihood that quick expansion is possible once the ball starts rolling?? Seems that word of mouth between the various systems might engender a competitive opportunity for marketing to encourage a little "keep up with the Joneses" type jealousy to increase sales.
I'm new here doing some due diligence. Anyone know the size of NSPH sales staff and whether they could develop a concentrated effort to go after the total V.A. system?
TIA
Apple signs agreement with China Union Pay.
I'm pretty sure Monitise has signed an agreement with China Union Pay. Don't have time to look it up. Can anyone verify? TIA
Question from the multiple-challenged investor??
Would anyone be willing to help out WE who are challenged by math (stat sig?), science, FDA study speak, and just plain old senility??
What sort of numbers/percentages on the primary and secondary endpoints would be considered
A) Super
B) Adequate
C) Borderline/ambiguous
D) Awful.
TIA
mcbio
could you provide more info about this new path that TRGT is blazing for CNS trials?
TIA