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Wednesday, 03/18/2015 7:52:42 PM

Wednesday, March 18, 2015 7:52:42 PM

Post# of 55
The Ischemic Stroke Press Release

Well, my friends, we are holding stock in the first company to show delivery of siRNAs to the brains of living animals. We got it past the BBB and the therapeutic worked for ischemic stroke, an all too common affliction that is in need of far better treatment. (What else are we going to be first to do? Lots, I suspect!)

It's great news, to be sure, and I'll discuss it, but I also want to discuss the press release itself and I do so below. I had also figured that there was a strong possibility that after the news release the market might react poorly and dampen the enthusiasm of shareholders and potential investors. I was right about that, too. So here's my take on it all.

The News

I believe investors need to consider several important pieces of news that were included in the press release, specifically:
• These results are from a study that biOasis had not announced it had even started. The implication can be recognized immediately. Investors need to consider whether other unannounced studies and initiatives might be underway. They need to consider when results might be announced and the effect that multiple successes could have on the market and on pharmaceutical companies. They also might consider the probability that all studies are designed to satisfy the due diligence needs of the pharmaceutical industry.
• The study was done in conjunction with the prestigious National Research Council of Canada. Investors can have confidence in the methods and reporting of the study.
• This is the first study to be made public by biOasis that proves that MTfp, the Transcend peptide carrier, works as hoped. No other known carrier is able to transport the quantities of therapeutics across the BBB that MTfp can transport. It's a point to be remembered that if a carrier can transport more therapeutic across the BBB than is required for efficacy, then physicians will have flexibility in prescribing doses, thus helping to avoid toxic dosing levels. Many other carriers, because they transport such a low percentage of a dose across the BBB, require large, often toxic doses in order to reach efficacious levels in the brain.
• The siRNA therapeutic worked. This means that the therapeutic, once delivered across the BBB, did not have its efficacy negatively influenced by that delivery, or by MTfp.
• biOasis is the first company to show delivery of siRNAs to the brain of living animals. So far, we're THE BEST and we're THE FIRST.
• Gene therapies are being developed by multiple pharmas for a host of central nervous system disorders. biOasis' siRNA news heralds the promise of efficacious delivery of many, if not most of these therapies. It defies logic to think that the pharmaceutical companies in this field would not be interested in these results.

The Press Release

Rather amazingly, there have been some rumblings about the press release itself. I say "rather amazingly" because the press release did state that what was set out to be proven, was proven, and it's no small thing. The PR certainly contained great news, especially since nobody else can do what biOasis reported in that press release.

Some people, both privately and on this forum, have expressed the wish that the press release revealed the name of the therapeutic, the gene that was knocked down and detailed data relating to all of this. I'll comment about this although I must be careful. As most of you know, I have a copywriting contract with biOasis and I did assist in the preparation of this press release.

As a general principle, I believe that all press releases, where possible, should contain some data and descriptions that may be (should be?) above the heads of average investors. It's just good investor relations. The lack of data and scientific detail can be a little off-putting to investors. Some investors may think that the company has something to hide. Others may think that the company is underestimating the capacity of investors to understand the information. They don't take kindly to the perceived insult, especially if they've put considerable study into their investment.

Beyond their purpose of informing investors, press releases do have a marketing function. Plainly speaking, the uninformed are often impressed by the highfalutin language and complexity. They may decide to do some studying to help them understand their investment. That's a good thing. Likewise, the informed are given some information to help them assess the news.

With respect to this press release, I really have no idea why data and greater detail were not included. It could be for protection of intellectual property. In this case, the three groups of animals were treated, respectively, with placebo, siRNA and MTfp-siRNA. In the press release, results with the MTfp-siRNA animals were compared to placebo but not to siRNA-only animals. If the siRNA-only comparison and related data had been included, it's likely that a competitor could determine the gene that was knocked down and the therapeutic that was used to do it. Competitors are very familiar with the stroke model used and they know the characteristics of the therapeutics. They could deduce the details. So that could be a reason for keeping it out of the PR.

And what about the pharmas that are watching biOasis' siRNA efforts? If the therapeutic were named, would any of them think that biOasis has a special relationship with the maker of that therapeutic? Would they suspect the same even if biOasis denied it? Could that prevent a call from being made to biOasis? Is it possible that biOasis wants to avoid contact with the maker of the therapeutic?

And what about the detailed analysis of the study data by the study participants? Could biOasis be sufficiently confident at this point of every detailed statement that it might make about that data? Later corrections or restatements are frowned upon.

It seems to me that what we got were top-line results and that may be all we'll ever get. And I'm ok with that. It's a discussion I did not have in detail with biOasis. In general, I don't want to know more than what I'm putting into the press release. That's the way I want to keep it.

But in the end, I'm no different than many of you. I would have liked to have seen that data.

The Study

There was a question on the forum about why the therapeutics were administered before the strokes were induced in the animals. I'll speculate on this and I suspect I'm not too far off. I may ask RH when I talk to him next.

By definition, strokes are the catastrophic failure of blood flows to areas of the brain. When a person has a stroke, it can be a mild one or fatal, or anything in between. There is no curing of the initial damage. The purpose of treatment is to prevent normal bodily reactions to strokes from causing more damage. It is essential that delivery of the therapeutic happens as soon after the event as possible. The degree of efficacy of the treatment depends upon how quickly it is administered after the stroke.

In a study like this, to be sure that all animals receive their treatments at the same time in relation to the onset of their strokes, I would think that the most efficient and accurate way of doing so would be to treat the animals before the strokes are induced. Unless there was an automated or accurately timed administration of the drug, post stroke, the elapsed time between stroke and its treatment could be so variable among the mice that the results of the study would be meaningless.

Treatment before inducement of the stroke may also ensure uniform distribution of the treatments within each study group. A stroke, by definition, is a disruption of blood flow in the brain. I would think that the strokes manifest themselves in varying ways in each animal. That could possibly cause varying distribution of the therapeutics among the animals. Again, pretreatment of the animals would ensure that drug distribution is as good as it can be within each animal.

The Market

Since the press release, trading in biOasis stock has been a disappointment, no question about it. It was pretty much what I expected and privately predicted. First of all, some investors, when they hold the stock for a long time without any news, look at news as a liquidity event and they sell. They just don't want to wait any longer. We got some of that. No surprise there.

Secondly, we had "Anonymous" seriously pounding the stock all day long. The selling was determined and relentless. "Anonymous" did not at times appear to be interested in getting top dollar for the shares they sold.

I could speculate further on what was going on but I won't participate in that conversation. I suggest we all just leave it alone. It's like the rain. It's going to occasionally rain on parades and golf games, and getting angry over it won't stop the rain. But do remember that the presence of dark clouds may mean rain. It's your choice whether you play when, in the future, dark clouds are threatening.

Our market will overcome "Anonymous" and will do it soon. Sooner or later his interests will align with ours.

Attitude

As usual, no matter how good the news, we had those who just wouldn't allow themselves to go with it. They had to criticize everything. It's like a marriage gone bad - hard words about everything but divorce is not considered to be an option. Some of you should pack your bags and leave the house. If you can't see where this is going, then you shouldn't hold the stock. You've driven yourselves crazy and you're intent on taking the rest of us down with you.

Stop the relentless, senseless, needless damage of your own cause! Your complaints and outrage are becoming tedious in the extreme! (I exclude Sir_Holler from this because he's a trader and will be our buddy when he's selling and our worst enemy when he's buying. I thought that I would spit up when I read the rubbish he posted on the weekend.)

And finally...

This press release signals the end of the first phase of the biOasis story, proof that MTfp works. We know some of the stuff to expect or hope for - Scarpa, Sandhoff, MedImmune. What else might be going on that we don't know about yet? The company sure got this one done on the QT.

I don't think I'm saying anything out of school when I relate a comment RH made to me the other day. It was sort of a throwaway comment, something obvious, but it was meaningful as well. He said, "We've crossed the blood-brain barrier. Next up is the commercial barrier."

When companies and people set goals, neither they nor we should be surprised when the goals are achieved.



This post was written by John D. I have copied it from off the other board.
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