From the Canadian Broadcast Corporation:

http://www.cbc.ca/news/health/stem-cell-clinics-1.3663955

USRM has no FDA approved products - that's just a statement of fact.

The stem cell industry is coming under increasing scrutiny. And that is likely to result in a hit on those clinics' ability to operate their business.

That's what they did with Woodford. His fund is effectively a large minority owner of NWBO. I also wonder if there are any side agreements between Woodford and Toucan Capital that might complicate a large sale of shares to another party.

But it is an interesting idea to sell some of Toucan's other assets/portfolio companies to raise capital for the benefit of NWBO.

http://www.hngn.com/articles/201627/20160703/us-businesses-guilty-of-providing-unlwaful-stem-cell-treatment-according-to-reports.htm

In my opinion and the opinion of others, in article after article, the FDA has and will begin to more closely scrutinize companies in the stem cell sector.

I'm generally not a fan of conspiracy theories, but it's entirely within reason to accept the possibility of interference inside the FDA by Big Pharma companies. There are scientist on various FDA committees with Big Pharma associations; Big Pharma pays a lot in user fees; and Big Pharma is very influential on the Hill.

Be interesting to hear the perspective from someone with FDA experience.

And U.S. STEM CELL is very involved with a stem cell clinic in Tijuana, Mexico. (Although don't know from the article if it's the same one as referenced in the quote below.)

Very interesting, indeed.

Yep, the lower the stock price, the potentially more dilutive that Roche payable becomes in terms of shares. At today's stock price, the amount of the payable converted into shares is north of 2,500,000 in additional dilutive shares. That would be approximately 40% more in outstanding shares - although it's hard to keep track of how many shares this company has at any point in time.

The case remains open against Greenbaum, who is the bigger fish, since there's no denying she's the one that actually injected the stem cells into the patients eyes. The case against USRM is more of a he said, she said kind of case, and much more difficult to prove.

Obviously Noble believes she was damaged by having those adipose derive stem cells injected into her eyes...

The FDA is starting to come down much hard on stem cell companies.

Powerful Statement...I wish the FDA would understand this and respond with more urgency.

Yeah, it's a two edged sword. NWBO is not so much a company as it is a vehicle to own the IP/ technology and to serve as a funding mechanism for the trials. If NWBO were simply a stand alone biotech, they would really be in trouble. But because it's Cognate that has to make payroll and pay the rent, not so much NWBO, this buys additional time. Note: We don't know much, if anything, about Cognate's financial condition, but I presume its cash flow positive since the company's been in operations for a number of years, even prior to the creation of NWBO.

The insider trading rules extends to all securities, including warrants and options. Linda or Toucan could probably make a loan, provided it's not convertible. It would be interesting to know if the Toucan funds could buy shares or make a convertible loan. Although I suspect the Toucan funds would be subject to the same restrictions, since Linda has dispositive control.

NWBO's financial obligations are largely due to Cognate and employes that also work for Toucan. So, the company could probable rely on deferring payments to Cognate and Toucan for a while, if need be.

This is becoming a case study in the potential pitfalls of a fund (controlled by one person) owning and controlling a public.

Not too on-board with the role of shorts in the recent volume and price movement. Shorts play various roles in the investment landscape and they tend not to be as critical in the movement of stock prices as much as it might seem.

I do believe those funds tied to the Russell Indexes were anticipating they would have to sell their holdings of NWBO, they were making deals with buyers for large volumes at very low asks. That's the likely reason why this stock has gone so low. Expect that the stock has stabilized and is so over-sold, we should see a nice bounce.

We live in interesting times.

Must have failed to clearly mention that the hospital and doctor described in the article that you click onto is the same hospital and doctor cited in the U.S. Stem Cell trial. If you had trouble with the link, here it is again.

http://www.thehindu.com/news/national/a-strange-project-to-revive-the-brain-dead/article8601787.ece

It's very relevant to investors if they want to know whether or not the trial was conducted at a reputable hospital or university.

I leave it to readers to decide for themselves.

Sometimes I just shake my head.

See the attached article that shows a picture of the Anapam Hospital in Rudrapur. The same hospital mentioned in the trial publication where some of the U.S. Stem Cell trial was conducted. Apparently this hospital does trials on dead people, too....presumably, because if you're dead, you're not really dead...or something like that. [Based on the picture, my guess is that parking is free at this hospital. I assume that's a good thing, especially if you're dead and don't carry a lot of change for the parking meters.]

http://www.thehindu.com/news/national/a-strange-project-to-revive-the-brain-dead/article8601787.ece

Dr. Bansal is one of the authors of the U.S. Stem Cell study.

The hospitals detailed in the trial article:

Author details
1 US Stem Cell, Inc, Sunrise, FL, USA. 2 Regenerative Medicine Institute, Tijuana, Mexico. 3 Consultant Regenerative Medicine, Mother Cell Spinal Injury and Stem Cell Research, Anupam Hospital, Rudrapur, Uttarakhand 263153, India.

Acknowledgements
This study was partially funded by Anupam hospital, US Stem Cell, Inc., and Regenerative Medicine Institute.

A new government could force a 2nd referendum, especially if there's an indication and strong belief that the "Leave" voters were deceived and now want to change their vote. The "irreversibility" comments were also one of the lies told in an attempt to scare the population into voting "Remain." When I wrote my last post I had not yet seen the "Bregrexit" stuff in today's news - so now I'm leaning a little more toward a 2nd referendum, maybe a 30% change of this happening.

The dynamic is not good since the other EU countries hate the English to begin with and would love to pack their bags for them, as in "see you later alligator." And many believe with the UK leaving, this will solidify support for the EU among the other member countries.

Does this have any effect as it concerns NWBO? My response it has no effect at all. Barring the George Soros predicted contagion (farfetched in my view) that results in chaos in the EU, the regulations governing drug approvals in the EU and UK will remain in place for at least a couple of years, which is plenty of time to accommodate any changes to the regulatory regimes.

Big Pharma is international in scope. This is not going to be a significant set back for new drug discovery and investment.

My theory on the irreversibility....

The Brexit will be such a slow motion disaster that after a year or so into negotiations for the exit, there will be some serious (and secret) discussions about rescinding or having a new referendum to remain in the EU, with the EU leadership's tacit acknowledgment .

Irreversibility is in part a function of Article 50 of the Lisbon Treaty about voluntary exits from the EU, but it's mostly a decision by the British Government to formally invoke Article 50 - which hasn't happened yet. It is not outside the realm of possibility the House of Commons under a new government could decide to reject the referendum. I don't believe that will happen, but I do wonder if over the next couple of years this goes in another direction.

If the Brexit is finalized, my guess within a decade or so the UK (or just England if the the UK falls apart) will reapply for EU membership.

The Brexit could also be Moses wandering in the desert for 40 years for the sins of his people, but I hope not.

When the stock price began drifting down, especially below $1/share, it added to the downward pressure on the price because funds that attempt to mirror the Russell indexes begin to sell (or decide not to buy) even before the re-balancing. There are also certain institutional investors that have restrictions on holding or buying any stock below a certain price.

That's another reason why the last capital raise was botched. It didn't account for the secondary effects associated with a lower stock price and the rebalancing.

The good news is that barring a disaster, the stock price is about as low as it can go. It's so low, that even a modest capital raise might still raise the stock price despite the dilution, just because it would improve the longer term outlook and lessen some of the uncertainty.

Maybe wishful thinking, but the company is due for some good news - maybe next week.

(I'm still in shock over the Brexit, It's almost surreal.)

On a day that the market and the biotech sector are down, and the Russell index is rebalancing, NWBO is showing some strength. Does make me believe there is a pending announcement, as we all know that information tends to leak out.

Again, keeping fingers crossed for next week.

NWBO should be very close to hearing back from the FDA.

Fingers crossed.

I should have said "perceived" bad news.

In reality, taking the perceived out of the equation, it's 90% uncertainty and 10% actual bad news.

My guess is they already told Woody how the cash was going to be allocated. In fact, I'm not sure how else they would have used the cash, since that was the purpose of the capital raise to move the project forward.

What I'm really curious about is why he didn't ask for a seat or two on the Board?

If every time I listened to your recommendation to buy more shares, I would lose my shirt. The stock is down again, today by over 20%!!!

Good time to enter??? What will happen to the stock price if USRM loses its lawsuit that's cited in the 10Q, and has to pay the alleged $42,000 past due invoice? That could easily add another round of serious dilution if the company has to issue additional shares to pay the claim. Wow, what's $42,000 divided by today's closing price at .021 per share? That's potentially another 2,000,000 shares of dilution, at the very least.

Then add all the dilution associated with existing convertible debt, and the level of dilution is just staggering. Can't wait for more press releases and public filings to gain more insights about what's going on inside this public company. I just can't wait to dig a little deeper.

NWBO is so oversold that even the slightest positive news provides for some technical correction to the upside.

The stock was hit by an avalanche of bad news and uncertainty over the past 10 months, both sector & market related and specific to the company. Short of a FDA related disaster or another bad capital raise, there's really no place else for this stock to move but up.

Not to say that the EU doesn't need reform, especially at the Commission, but the UK is much better off to stay in and attempt to take the lead on instituting changes.

Very inspirational.

Even as a novice to the science, I had the sense that this is a very unique situation.

Another potential problem is that Cognate is subject to Rule 144 of the SEC code for re-sale of restricted stock by affiliates, which among other things may require holding periods and special reporting requirements.

So, by paying Cognate in shares rather than cash, there are potentially Nasdaq, SEC and Bylaw issues that have to be navigated - better to just pay in cash.

Yeah, it's mostly wrong.

1) NW could purchase additional shares from the company through a private placement - after all, he had inside information when he made the last purchase;

2) Cognate is a controlled affiliate and therefore subject to various rules for restricted insider purchases, similar in effect to the rules for other insiders of NWBO;

3) LP is limited to insider purchases through planed purchases in accordance with 10b5-1 of the SEC regs. She can't purchase shares with non-public knowledge of a material event.

For the kingdom that gave birth to David Ricardo and Adam Smith, you would think the population in the UK would understand the importance of free markets and trade for creating wealth.

But for some reason they struggle with concept.

My belief is that LP has so much vested in time and money, and NWBO is likely the linch pin for the Toucan funds, that she will make every effort to manage the finances. It's pretty much a crisis situation, so I'm sure they're scrambling.

Maybe she can pull a rabbit out of one of those hats?

The good news is that the stock price just reflects a point in time. There is still a couple months for some meaningful events related to the trials to raise the stock price. Events that include regulatory approvals, joint business arrangements, non-dilutive funding, etc., could be drivers for improvement in the stock price This is not to minimize the downward trend or the problems that could result, but it's important to provide some additional context for those that believe its time to throw in the towel.

Options w/ regard to funding:

1) Do nothing and just wait this out until something accretive happens. This is an option if it's just a matter of timing, whereby management is confident a deal will close and/or the FDA is just addressing some formalities before offering something positive, then okay;

2) Loan/credit support from Cognate – not sure how feasible this is, since we don’t know anything about Cognate's financial condition and whether it could raise funding on its own or guaranty a loan for NWBO. What's more likely is NWBO could “stretch the trade” with Cognate, and deferring payment to them for an additional 30 to 60 days or so. But again, Cognate as a bankable company or source of additional funding is completely unknown;

3) Funding from Toucan Capital – this is possible, depending on how much equity they can tap from their investors;

4) Incremental capital raises are a possibility to buy some time, without creating large scale dilution all at once at these depressed stock prices;

5) Some combination of 2,3, and 4;

I will use this opportunity to once again re-iterate that the company does need to be speaking with potential buyers. Unless there's certainty (Point 1), and they definitively know of accretive news within in the next couple of weeks, then selling the company now is a better alternative for shareholders versus slowly draining the company of value over time, given the continued uncertainty.

And the science will advance more smoothly in strong hands, rather than weak hands.

I get it, but England's history is not much different than that for Germany, France, Netherlands, Spain and Portugal. All were colonial powers that retrenched and all have strong national pride. I know it's simplistic, but I do think it's because England is an island nation that makes them feel discounted from the mainland.

It would be foolish for Britain to leave the EU. Although the thinking is that Britain could achieve similar trade relations through bi-lateral treaties, the EU would very much look to punish Britain, and I doubt they would gain any advantage.

For whatever reason, Britain has always seen itself apart from the countries on the continent.

The Brexit vote and the UK's potential departure from the EU is very destabilizing. Not so much the effect from losing just Britain, which never adopted the Euro anyway, but the possible contagion that could result from the rest of the EU breaking apart. I'm sure this results in a great deal of uncertainty in biotech, since research, trade agreements, and the regulatory environment could be significantly altered. What's a little more concerning is financial investors may stay on the sidelines until the smoke clears.

NWBO may already have signed agreements in place subject to certain conditions being met. So it's possible the Brexit has less of an impact than perhaps deals that are just at the negotiation stage. Very hard to say.

This has the feel of uncertainty that existed during the financial crisis.

The good news is the trend is leaning towards remaining in the EU.

From the NY Times:

"As the campaign has progressed, the odds against Brexit have gradually become smaller. Betfair, a betting exchange, has “Remain” at 60 percent probability."

Thanks, Chris.

it's crunch time, and I'm sure they're pressing the FDA for a decision. Maybe the one benefit of Toucan Capital is the reluctance to dilute their own investors at the fund, which might provide the incentive for some creative solutions for at least short term capital. And they can always stretch the trade (i.e., slow pay Cognate) to gain some additional time.

We have no visibility into Toucan, but perhaps the fund itself can raise some short-term (non-dilutive) capital?

Their ducks need to be lined in a row relatively soon.

Chris, in speaking with various people that have knowledge of the company, are there any insights you can share about NWBO's financial condition and what options it has available for funding? It does appear that sometime this summer, they will need to either enter into another capital raise or receive funding from the pending collaborations. Or something else?

I more or less take the science for granted; it's the financial management that keeps me on edge.

Not sure I have much choice (laugh).

I recognize there is a great deal of uncertainty surrounding NWBO, and there are things I see that very much bother me about this company. But just based on my understanding of where they are in the trials and some of the other activity surrounding the company, I have to believe that NWBO pulls this off in the end.

The announcement of the SAB is very compelling....

That's a world class science advisory board that was (supposedly) recruited by this little small micro-cap company with 12 employees. I have to believe there are already agreements signed with Big Pharma (that recruited those members) with condition subsequents to be met before an announcement.

What those conditions might be is probably better understood by the oracles on this board, but I suspect it's FDA related, perhaps even tied to the response to the halt.

Too much seems to be wrapped together to be a coincidence.

This is just so on point. I cringed with the suggestion of AA in late 2016 or early 2017. I'm betting on news much sooner - the review process takes about 10 months plus time to accommodate requests for additional information...so, that puts us into about now.

And I believe that's why the warrants originally had 60 day expirations, and then the FDA requested additional information that threw them a curve ball in terms of timing.

I will say this about that:

This is an election year, which makes for a very weird time in Washington. There's a lot of jockeying and pieces moving of various sorts in the political establishment. And in this environment, it's not all that obvious to me that Biden will really do anything, other than perhaps offer some lip service. For example, his speech at ASCO was rather vanilla, and I suspect it was vetted so that no campaign contributors or politically active groups would have any reason to be offended or take issue.

I'm sure Les is a good guy.

I do believe there are corporate governance problems and structural issues with how this company is managed. I would bet dollars to donuts that's why many institutions have kept away. But that's a professional observation of management, not a personal one versus the individual professional at the company.

That wasn't directed at you, your comments were well expressed and appreciated - I wasn't referring to your comments as pollyanna. Sorry if I came across that way. But there are some that are in fact pollyanna.

Keep in mind the stock is at 66 cents for a reason.