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MediciNova Announces Positive Top-Line Results from the Clinical Trial of MN-166 (ibudilast) in ALS (https://finance.yahoo.com/m/e3f98ddc-820c-3c3a-8485-7f469aaf4c3a/medicinova-stock-up-more-than.html)
I do love MNOV. Because the price jumped over $10 after hours (before falling back)? Nope. It's progress in ALS research. There's no finer way to invest.
Kind regards,
Minding
coderas, I thought I read it will be webcast.
Minding
Not without cause, laser. What you've seen is what you'll keep getting.
I put my shares in a 'box' and check the news regularly for promises to be fulfilled. They haven't been. The stock price trend reflects this.
To succeed in business, you have to succeed in business. No amount of cheering on this site will change that.
Kind regards,
Minding
My post, though spurred by your post, wasn't targeted at you but to the general discussion about early expectations. I appreciate your insights.
Kind regards,
Minding
I posted some time ago that expectations here for an early decision were unrealistic. It would've been great, to be sure. But it's best to not know when one doesn't know.
I've seen nothing to indicate we shouldn't expect a positive decision and nothing to indicate when that decision will come.
This is a time for patience.
Kind regards,
Minding
Alan, all of these recent changes are so frustratingly long overdue, it's difficult to derive any satisfaction in the appointments.
One of the more challenging aspects of investing is watching management waste a really good business opportunity over a long period of time.
Kind regards,
George
Thanks, codaras. I remember your position. While replying to your post, I was asking more generally. There seems to be a high expectation here for word any minute and I think it unlikely.
In the end, whatever works!
Kind regards,
Minding
I posted a fairly detailed note (https://investorshub.advfn.com/boards/read_msg.aspx?message_id=134189881) asking those who were saying we should hear around 60 days please provide links supporting that position and received no responses.
In my post, I provided links suggesting we should expect the process to take longer. In other words, the lack of at decision at this point is not informative.
Kind regards,
Minding
xrhodie, would you provide links to the 'hints'?
Thanks,
Minding
Thanks xrhodie. It's good to know KSS and I are in agreement. ;)
Minding
I agree with codaras. There was no news in the presentation nor was any expected. The value was in exposing new investors to the company.
Kind regards,
Minding
Good thoughts, UFO. It's best not to take this stuff personally and to come to the markets loaded for bear. ;)
Minding
Thanks tfris. I was a member in 2014-5. I may consider rejoining though I haven't missed it.
Kind regards,
Minding
Thanks Amateur.
Kind regards,
Minding
UFO, thanks for the older Dr. KSS articles. Do you have anything more recent than 2015? Thanks.
Kind regards,
Minding
FDA approval:
I've seen a few mentions of the FDA approval process for a 501(k) taking 60 days. To be clear, I have no expertise, but my understanding is that it is much longer. One source told me 9-12 months. Another (https://www.meddeviceonline.com/doc/how-long-does-the-fda-k-review-process-really-take-0001) says:
FDA sets goals to review and respond to 510(k) submissions within 90 days, it is an uncommon occurrence thanks to the time required for you to respond to additional information (AI) requests. “The 90 day goal set by the FDA should largely be ignored when you are trying to determine how long it will actually take to get your 510(k) reviewed and cleared,” Schorre concluded. Plan on the process taking closer to six months.
The FDA says that by day 60 they conduct a Substantive Review (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm#timeline) They also say "The FDA goal to make a MDUFA Decision for a 510(k) is 90 FDA Days (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm#decision)"
Perhaps those saying 60 days could document (i.e. provide links) supporting that position.
Having bought and rebought and held all I've bought over the past few years, I of course prefer the 60 days! Knowing may affect some actions I plan to take leading up to approval which I, like everyone here, hope is unimpeded.
Thanks,
Minding
The stock price today (and for quite some time) is reflecting investor-at-large opinion on this company's promises, delays and travails. They know ... as does Nasrat ... that the longer this continues, the smaller the window of opportunity.
Kind regards,
Minding
Rockwell Medical involved in board proxy fight, lawsuit with major shareholders
By JAY GREENE
Comments Email Print
Rockwell Medical Technologies Inc. Health Care Legal Issues
Rockwell Medical Inc. of Wixom is embroiled in a dispute with two large shareholders in the company who are critical of the company's growth, governance structure and alleged lack of communication with shareholders.
They want a seat on the governing board, which will expand to six this summer.
The dispute has spilled into court with claims and counter-claims between Rockwell (NASDAQ: RMTI), a biopharmaceutical company targeting end-stage and chronic kidney disease, and top executives at Jackson-based Richmond Brothers Inc. and Tri-Star Management in Minneapolis.
Richmond Brothers and Tri-Star, and their clients, represent 6.1 million shares, or 11.9 percent of Rockwell's outstanding common stock. David Richmond is chairman of Richmond Brothers and Mark Ravich is co-founder and president of Tri-Star.
The outspoken shareholders have been asking Rockwell for several months to improve sales of Triferic and Calcitriol, restructure governance and add a shareholder representative to the now five-member board.
In 2015, Rockwell won FDA approval for Triferic, a promising iron replacement therapy that is getting good reviews by clinicians in an ongoing drug sample program, but sales have been sluggish for a number of reasons. Calcitriol is a generic drug for patients undergoing chronic kidney dialysis. Once the FDA approves Calcitriol for manufacturing by Rockwell, expected this year, the company intends to market the active vitamin D-based injectable drug for hemodialysis patients.
Rockwell President, CEO and Chairman Rob Chioini told Crain's he has reached out to the disgruntled shareholders to explain the company's long-term strategy is to grow revenue by first securing the highest Medicare reimbursement possible, signing lucrative contracts with national dialysis companies for Triferic and expanding sales internationally through partnerships.
Rob Chioini: Rockwell Medical president, CEO, chairman.
"We address their concerns when they come up. We communicated with him (Richmond) perfectly," Chioini said. "We have met with and tried to work with David (Richmond) and for whatever reason, we are where we are today."
Officials for Richmond and Ravich declined to talk on the record with Crain's about Rockwell. Instead, they pointed to various press statements and SEC filings.
On April 5, Richmond and Ravich filed a proxy statement with the SEC in connection with Rockwell's upcoming annual summer shareholder meeting. The meeting is scheduled for June 1. The Richmond statement questions Rockwell's recent announcement to improve corporate governance and contends the company would not have taken action if not for their criticism.
"History has shown that the company has not been interested in making proactive change absent a looming proxy contest," said a statement from Richmond and Ravich. "We are also concerned that the company's newly acquired interest in improving its corporate governance practices may be abandoned if a public shareholder representative is not elected to the board."
Richmond and Ravich have asked shareholders to support their nominee — Ravich himself — for election to the now five-member Rockwell board. It will expand to six at the June 1 annual shareholders meeting.
"We are seeking representation on the board because we believe that the board will benefit from the addition of a direct shareholder representative committed to good corporate governance practices and an objective of enhancing value for the benefit of all Rockwell shareholders," the statement said.
Richmond said in the statement that Rockwell has had two years to improve sales of Triferic and Calcitriol and that the company continues to flounder financially.
For fiscal 2016 that ended Dec. 31, Rockwell generated sales of $53.3 million, down from $55.4 million in 2015. Net loss for 2016 was $19.8 million, or 39 cents per share, compared with a loss of $14.4 million, 29 cents per share, in 2015.
Two sources, who asked to remain anonymous, told Crain's that it is not unusual for some people who invest in startup biopharmaceutical companies to get impatient with the time it takes to monetize intellectual property like prescription drugs. The pipeline from idea to clinical studies to federal approval and then sales can sometimes take 12 years or more, they said.
Since 1995, when Rockwell was founded by Chioini, the company has evolved from a medical device clinic selling dialysis kits and related items to a fully integrated drug company. It now has 300 employees with plants in Michigan, Texas and South Carolina.
"Unfortunately, management and the board have failed to heed these signals of shareholder discontent and have persisted in running Rockwell as if it were a private company not accountable to the interests of public shareholders," according to a March 2 statement by Richmond.
Chioini told Crain's that management takes seriously shareholders' concerns. He said Rockwell is in the process of improving the board and has proposed a number of other improvements.
Last June, Robin Smith, former CEO of NeoStem, was appointed to the board. This year, Chioini is recommending election of David Domzalski, 49, a drug company executive with more than 20 years experience. He has been president of Foamix Pharmaceuticals Inc. since 2014.
Moreover, in an April 4 statement, Rockwell said it has implemented the following governance improvements: appointed Patrick Bagley as lead independent director; and formed a governance and nominating committee.
It also is proposing several new compensation governance practices for 2017, including the annual bonus program and added management share ownership guidelines, an anti-pledging and anti-hedging policy, a clawback policy, a cap on annual bonus payouts and hiring of an independent compensation consultant.
In SEC filings, Richmond and Ravich made suggestions to improve the board and management, including adding a shareholder and expanding clinical trials, but all have been rejected, they said.
For example, Richmond and Ravich have complained that Rockwell failed to communicate its Triferic pricing strategy to shareholders.
David Richmond: Chairman of Richmond Brothers.
"It has now been over two years since the approval of Triferic (September 2015) and more than three years since the approval of Calcitriol, the company's vitamin D drug, and Rockwell has failed to generate revenue from either," said Richmond in a March 2 statement. "We believe this clearly calls into question management's strategy and competency to successfully build shareholder value."
On Friday, Rockwell's shares were trading at $8.01, down from about $11 right after the FDA approved Triferic in January 2015 and lower than the company's five-year high of $16 in 2011.
At the time Rockwell secured FDA approval for Triferic, Chioini told Crain's Triferic was expected to boost Rockwell annual sales by at least $200 million and as high as $600 million over the next five years.
"This is a pretty big deal for a lot of reasons — for our company and for the 400,000 patients in the U.S. that can use this drug," Chioini said in a March 2015 interview. "It is a business-changing kind of event."
But later that year, in November, Rockwell announced it would seek transitional add-on payments for Triferic from Medicare instead of bundled pricing, which is what Medicare offered Rockwell. Transitional payments are higher prices Medicare pays for new drugs for two years to encourage use by providers.
Chioini said seeking transitional payments for Triferic was the right decision, even if it means sacrificing short-term revenue gains. He said he expects Medicare will approve transitional payments this year.
"Transitional is a better payment than the bundle. We are actively marketing the drug," said Chioini, adding that Rockwell has been providing Triferic as free samples to dialysis centers and is getting positive feedback about how the drug is helping patients.
"We are also very pleased with the response, and the positive clinical findings being reported from dialysis providers using Triferic through our drug sample program. Our marketing and education efforts on Triferic have been well-received and continue to be very effective," Chioini said.
But over the past 12 months, as Richmond and Ravich began to criticize Rockwell's pricing strategy and issuing press releases and statements criticizing Rockwell's management and governance, Rockwell this year filed a lawsuit against Richmond Brothers alleging certain violations of the Securities Exchange Act of 1934.
Rockwell alleged that Richmond and Ravich, along with four other shareholders, failed to file a 13D document on time with the SEC that informed the company that certain shareholders were working together in concert and had effectively become "activist" in nature. Richmond and Ravich said they filed the so-called 13D document earlier this year as soon as they were legally required.
"We believe Rockwell's allegations are baseless and untrue. We intend to vigorously defend ourselves against these accusations, and we believe that the facts are on our side. In our view, this lawsuit is nothing more than a desperate attempt to derail our nominations and maintain the status quo."
Chioini said Rockwell filed the lawsuit because Richmond and Ravich failed to inform the SEC in a timely fashion that they had become activist investors. A hearing is set for May 3 in the U.S. District Court in Detroit.
"They (Richmond and Ravich) made it sound like management is bullying them," said Chioini. "I have reached out to them. We are hoping to get this resolved before our board meeting. We are wasting a lot of time and expense."
In a 2015 interview with Crain's, Chioini said Rockwell planted to negotiate contracts with leading national dialysis companies, including DaVita Kidney Care and U.S. Renal Care.
"The strategy hasn't changed. We will still sell and market with (dialysis companies)," he said. "What has changed is that we are waiting for (Medicare) to grant us transitional payments for Triferic."
Chioini said he has been to Washington, D.C., at least 30 times to talk with officials with the Centers for Medicare and Medicaid Services. "We think we are close and will get it this year," he said.
But in the meantime, Richmond said in statements that Triferic sales have been much lower than shareholders expected.
Last month, Rockwell released financial results for the fourth quarter of 2016 that were $13.4 million in sales, or $700,000 lower than the same period in 2015. Net loss was $5.1 million or 10 cents per share compared to a $5.8 million loss, or 12 cents per share in the same period in 2015.
Re: Cola's visit to NYC
What a waste of money for an outfit that doesn't have revenues.
I hope NASDAQ is paying their travel expenses.
Minding
ER, I've been enjoying your success vicariously. Great job!
Minding
Alan, you've proven your worth here time and again over a long stretch of time. Many of us are down (me with only a toehold but down none-the-less) because we didn't listen to you a few years ago.
These kinds of pops happen often enough with micro-caps and they frequently settle right back down. I always gravitate to speculators for my explanation when the pop down matches the pop up. I hadn't given a lot of thought to insider manipulation with SGLB until you brought it up. If the stock retreats to $1-ish, I'm going with speculators. If this holds in the $3 range, I'm onboard with you.
Either way, a solid company proceeds in ways that allow their investors to have a clear idea of what's happened, what's happening, and what's coming so all investors, not just a few insiders, have a good idea of when to get in. If this isn't speculation then it's management that results in this kind of surprise move.
Best,
Minding
Jeff,
I'd like to see more details before concluding anything about the single contract they've secured (i.e. one year? Ten?) More importantly, I'd like to see more contracts, I'd like to see something (at this stage miraculous) from GE, I'd like to see the Board act like a for-profit board.
It's been a long road. Sigma Labs has acted more like a research lab than a business for the entire trip. I've seen countless startup businesses develop and market a technology over the past 25 years, successfully and unsuccessfully, but never one that didn't understand they were a business.
I really want to see Sigma Labs act like one of those businesses. Like a growing concern fulfilling their potential. I've begun to doubt their capable of it.
Holding. Waiting.
Kind regards,
Minding
Hey chef.
Volume might be of interest to me if it was in the millions, but more particularly if a rise like this was preceded by accumulation. There has been none so this, in my view, is pure speculation moving the stock. Good for a trade.
I'm happy to be surprised since my marker shares are down 70-75%! But I don't think I'll be surprised.
All the best to you in 2017,
Minding
Right I left that out. Thanks. The contract was certainly enough to motivate speculation. But there's no sign of serious investors, that I'm seeing.
Minding
Hi Alan,
Very nice to see your message. I'm traveling but will return home later today and send a longer response.
The short answer is that I seem to have endless patience I wasn't aware I had ... and perhaps shouldn't have in some situations. ;) ARTH is one that warrants it however.
All the best in 2017.
George
ER, no credit to me except for sharing this with you. I got ARTH elsewhere (I believe I'm not allowed to mention the forum here) from two investors I rate highly. They focus mostly on high yield investing but every once in awhile something like ARTH pops up.
These guys rate the management very highly (http://www.archtherapeutics.com/about/leadership). The hardest work was accomplished a few years ago (http://www.archtherapeutics.com/technology/milestones). There seem to be processes but not potential roadblocks that will, if I'm not mistaken, take a year or more to complete. So the product won't reach the market for awhile.
That said, these investors and I see this, as much as any investment can be, as a lock. We haven't been trading in and out, though one could have and could going forward; just stuffing shares in a drawer, watching the unfolding carefully, and waiting patiently.
Kind regards,
Minding
PS I no longer give money to iHub because of difficulties on another board (with moderators favoring some posters over others) so I don't have access to private messaging. As a result of that experience, I was wary of posting ARTH info on the BCLI board too. But this works better anyway.
For those investigating ARTH, here are a few (randomly selected) links that may be of interest. Check the dates as they aren't all recent.
Also, as always, see the 10-Ks and 10-Qs.
Kind regards,
Minding
https://www.rdmag.com/article/2016/12/stopping-bleeding-better-hemostatic-device
http://www.archtherapeutics.blogspot.com
http://archtherapeutics.blogspot.com/2016/12/therapeutics-arth-catalog-of-articles.html
http://wsw.com/webcast/aegis3/arth/index.aspx
http://wsw.com/webcast/rrshq26/register.aspx?conf=rrshq26&page=arth&url=http://wsw.com/webcast/rrshq2
6/arth/index.aspx
http://cosmeticsurgerytimes.modernmedicine.com/cosmetic-surgery-times/news/ac5-topical-hemostatic-device-achieves-study-endpoints
http://ir.archtherapeutics.com/press-releases/detail/480
Dr. KSS at StockGumshoe has a fair amount to say if you're a subscriber. I've seen some of his stuff thanks to a friend but I am not a subscriber.
Post by Regis in July: http://investorshub.advfn.com/boards/read_msg.aspx?message_id=124227665
BCLI chart looking good.
I'll post a few things in the ARTH board.
Minding
ER, it's difficult to remain high energy with the contents of my bucket because they have and continue to take longer than expected which has resulted in price drops ... and I had to jettison two this year for losses which was not fun. Some I hold have had a glitch here and there however they all continue on-track which is why I remain in them. It feels like mile 18 of a marathon.
I can only recommend one with some enthusiasm: ARTH. They have a synthetic peptide for stopping/controlling bleeding during surgery and trauma care. They have a much easier path to approval than BCLI, MNOV, etc.
Minding
ER,
Here's my problem. I'm in (probably too) many of these kinds of companies (including another doing ALS research) and I'm not equipped to handicap any of them. I should be more judicious because of that but so many are doing really good work (like BCLI) and I prefer this kind of investment, investment in good efforts. In the end, we simply don't know until we know what we know.
Until and unless one of my current holdings either fail or succeed, I can't let myself jump back into BCLI. I will live vicariously through your investment in them.
The way I learned to assess a prospective stock price involves current price, outstanding shares, and market cap. At this stage, BCLI should have a much higher market cap. I find that worrisome, but if they succeed with Phase 3 with no need for more cash, their 50M market cap should jump to 350M or more. That would put the stock price at 18.73 --- may it happen for them and you!
Minding
Persuasive ER and I agree about the important work. OTH we must remember that Phase 3 is the most difficult to get through.
Minding
long trailer, I think you got a good price. (Who knows?) I would expect it to remain around that price until there's news (not just any press release.)
ER. I'm going to your link to the CC in the next few days. Thanks for the facts, your opinion and the link.
Kind regard,
Minding
Without prospective news in the near-term, I expect this to do what it did in July.
Minding
The release on the 19th was vague on the timeframe going forward because they are just developing a Phase 3 plan. These guys may be undervalued but that doesn't guarantee the price will move anytime soon. Is any other news expected in the next year?
Thanks,
Minding
I got out of BCLI in July after the sharp rise resolved to check in frequently. I missed early_retire when he posted about 19 December and so missed getting back in before this most recent move. I'm back to 10Qs and 10Ks and press releases and presentations to evaluate things.
We're talking small studies, 48 people and now 24. If anyone has expertise with these kinds of studies, I for one am interested in having you share your knowledge.
However from a purely canned approach taught to me by a very good investor, I agree this stock is undervalued, perhaps by as much as $10-12. His formula is pretty simple -- he looks at the Market Cap. At this stage, he would predict BCLI should be up around 250M.
Divide projected market cap by outstanding shares and you get the projected price.
Kind regards,
Minding
Seriously.
http://thefly.com/landingPageNews.php?id=2461867&headline=KOOL-Cesca-Therapeutics-files-form-to-delay-Q
Kind regards,
Minding
This label issue? Not forecast by a genius CEO? Naw.
Look I like Nasrat. He's doing a pretty good job. But he's also screwed up and it doesn't get admitted here. It's no crime. We all screw up. Just a little less irrational exuberance please.
I'm holding. I have enough for that wealth transfer if it comes but the longer it doesn't come while others are progressing the greater the slope of the mountain.
Minding
Nasrat: If we run into more trouble with the FDA ... we'll pick up our blocks and go play elsewhere.
Far different from "Nothing will stop us."
Minding
No. You had to send questions in advance for reasons that are inexplicable.
Minding