I'm back after a long hiatus. I left because IH message boards suck. But compared to the new Yahoo Message Board format, even this is much better.

Doubtful. Conferences typically don't have any effect on PPS since there is rarely anything new announced and most investors know that.

Not good. Hopefully, the "interim" CEO doesn't follow him.

As a former PYMX investor, I can respond to that.

"Brilacidin had already been in a phase 2 study and appeared to show good therapeutic efficacy at low doses but 85 % of the patients had suffered with severe numbness and tingling, 5 dropped out and there was at least one severe untoward reaction."
- Wrong! Numbness and tingling were characterized as mild and went away upon discontinuance, mostly at the end of the 5-day dosing regimen. In addition, analysis of the treated patients, including serum levels of Brilacidin, indicated a much shorter course of treatment at low dose levels would likely provide a full cure, thus minimizing the side effects.

"The CEO,Mr. Nicholas Landekic was in the pharmaceutical field for over 25 years and had ties and connections to Bristol Myers Squibb as well as Johnson and Johnson.
Do you honestly believe that he would not have contacted these people and told them of this great opportunity?"
- Yes, I believe either he would not have or that they refused to bargain with someone with his huge ego. Many times, Nick claimed Polymedix would "become the next Amgen". In reality, he pissed off so many both potential pharmaceutical partners and potential large investors that he alone was the primary reason for the company's ultimate failure. By the time the incompetent Board of Directors finally ousted him, it was way too late.

From the Brilacidin Fact Sheet:
"The most common adverse event experienced by patients in the study was numbness and tingling, felt by 65%-87% of treated patients. The majority of the cases were rated as mild and no patient discontinued due to just numbness and tingling. Excluding the numbness and tingling, the treatment-related adverse events were 9.6%, 5.6%, and 7.4% for the low, medium and high dose of bri-
lacidin vs. 10.9% for daptomycin. Eight patients discontinued treatment due to treatment-related adverse events. Three patients
that received brilacidin experienced a treatment-related serious adverse event Two of these patients discontinued treatment due
to hypertension (one medium dose and one high dose)."

Tax withholding. Read the 8-K filed on Sept. 18:

"On September 18, 2013, an aggregate total of 225,002 shares vested for the named executive officers. In order to satisfy the minimum tax withholding requirements incurred and payable at the time of this vesting event, the Company withheld 75,850 shares from the named executive officers, which are reported as a disposition of shares related to the vesting of these awards. As the minimum tax withholding amounts do not fully satisfy the tax liabilities incurred as a result of the awards, some or all of the recipients may periodically sell some of their shares, either as part of a 10b5-1 plan or other permitted dispositions, to fund tax withholding obligations and for other tax and financial planning purposes."

I don't think there was much, if any, concern about bacterial resistance to Brilacidin. According to Polymedix, its action is completely different from current antibiotics, which must enter the bacteria to work. Bacteria have developed ways to deal with antibiotics that work that way, including automatically ejecting the antibiotic before it has the chance to kill.

Brilacidin works by disrupting the outer skin of the bacteria, causing it to basically explode. According to Polymedix, bacteria would have to completely change their structure to counter Brilacidin's action, something that is highly unlikely.

Yes, I am interested. That said, I don't think there's any rush and I would like to see what Cellceutix' plans are for financing the P2b trials for ABSSSI and P2 for Oral Mucositis.

In Polymedix's Brilacidin (PMX-30063) Antibiotic Fact Sheet, published in February 2013, it was stated "Based on the successful results of this trial, which suggests that shorter courses of therapy and lower doses could be effective, a dose-optimization Phase 2B study is planned. The Phase 2B will study lower doses and shorter courses of therapy." Brilacidin (PMX-30063) Antibiotic Fact Sheet

EasyRider,

As I recall, it was also stated by Polymedix that shorter dosing schedules (1-3 days versus 5 days) would limit SAE's. I believe blood serum tests pointed to efficacy in the shorter time frame.

That is a two-headed snake. Shorter dosing regimens mean less chances of SAE's and lower hospitalization costs but can also mean less profit for the manufacturer. Perhaps Cellceutix can overcome that by charging more per dose based on the other potential savings?

Agreed, though I think BP's lack of interest in Brilacidin had as much to do with Polymedix management's attitude. Nick Landekic was despised within the pharmaceutical community.

gizmo - hypotension, not hypertension.

Actually, Polymedix didn't fall under the radar - it was pushed. Nick Landekic was despised by pharmaceuticals. He alienated every interested party with such statements as "Polymedix will become the next Amgen" and such.

We formed a Shareholders Action Group and attempted to push management to make a deal, among other things. It was a complete waste of time. It didn't help that there was infighting within the group but even when we could agree on goals for the company, they wouldn't listen.

That is a valuable lesson I learned - it doesn't matter how great a technology is; bad management trumps good science every time!

Brilacidin? Not sure, but at least one of their candidates was supposedly being developed for bio-warfare defense.

I honestly don't know the answer to that. I believe they did but towards the end, the science took a back seat to their money problems. By late-2012, it became painfully obvious that something was seriously wrong with management and the BOD. In December of 2012, all appeared to be great - the company stated that PMX-60056 (Delparantag) trials were proceeding as planned and that PMX-30063 (Brilacidin) trials were completed and preliminary results were excellent.

At a (December, 2012?) press conference discussing the Brilacidin preliminary results, questions about Delparantag were deflected with "we're here to talk about Brilacidin". In hindsight, I am fairly certain the hypotension issues were known at that time. Their (April? - I have trouble remembering exact dates) conference reporting the full results of Phase 2a of Brilacidin likewise had no mention of Delparantag, nor was it mentioned at their Shareholders meeting in May. A number of investors confronted Nic at the SH meeting and his expression was described by one as "a deer in the headlights".

The final straw was when they defaulted on a $6.8M payment to MidCap Financial but by that time, the BOD had finally (too late) ousted Nic and replaced him with the CFO, Edward F. Smith - another great piece of work.

At one point, they were supposedly experimenting with Polycide in sutures, catheters and implants too, though as time went on, they concentrated on Brilacidin for ABSSSI and as an oral rinse for Oral Mucositis and stopped talking about the other candidates in their pipeline.

I even talked to their IR a few times about the possibility of approaching the Bill and Melinda Gates Foundation for funding PMX-30024 anti-malarial drug development and various pharmaceutical companies about Polycide.

In hindsight, it appears Nick Landekic had such a huge ego that he turned off every potential partner. Perhaps Cellceutix will be different...

Polymedix was calling one, the other or both Polycide. This is not the same product as Polycide PHMG, which is currently a marketed product.

That was our hope. It didn't pan out but hopefully new ownership can do something with the technology. Hey, they can't do any worse than Nick Landekic if they tried!

It depends on the indications and how much you believe Polymedix' statements. Daptomycin supposedly has a $700M market and Vancomycin has a supposed $200M market. If Brilacidin picks up 50% of their market, that would be $500M.

BUT, if you believe Polymedix' claims that there is little-to-no likelihood of bacteria developing resistance to Brilacidin, and in light of many reports of bacteria strains becoming resistant to both Dapto and Vanco, and assuming P2B trials prove 1-3 day dosing, vs. 7 days for the alternatives, Brilacidin could literally take over the entire market. That would yield up to $1B market for MRSA and ABSSSI alone.

Brilacidin was also tested on a number of other gram positive bacteria in labs and supposedly worked well on over 1,000 strains, if I recall correctly, including Clostridium, Listeria and Enterococcus. If Brilacidin is approved for one indication, I'm certain it will be tested for others.

Potentially, it could replace numerous antibiotics, especially if it proves out that bacteria cannot develop resistance to it.

One thing I always wondered is why Polymedix never put any effort into developing what I felt would be their ultimate money maker: PMX-50003 - antimicrobial polymer biomaterials. Essentially, it is a product that could be applied to surfaces as a coating or paint or actually formulated into the material that would kill almost any bacteria on contact.

Haha!

"Subject to the availability of adequate cash resources, PolyMedix plans to initiate the Phase 2B dose-optimization study in early 2013."

That was the big letdown. They never got the cash resources. Then they tried to reverse split, uplist and sell shares at the same time. They never got enough interested buyers to avoid defaulting on their loan and that was the end of them.

Whoops,

Not an investor yet. PYMX made me somewhat shy about biotech investments. I am doing DD on the company, figuring there's no rush to get in if I decide to do so.

Brilacidin actually has the potential to replace Vancomycin for ABSSSI and MRSA. Phase 2a suggested much shorter dosing times (as little as one or two days) would lead to cure. That's huge when adding up the typical costs for hospitalization. In addition, Brilacidin showed efficacy against other gram positive infections in pre-clinical trials.

But that was just the tip of the iceberg, as far as I was concerned. Their pre-clinical candidates for fungus infections, malaria and TB, were the areas I was most interested in.

I don't know how long it'll be on the internet since most of Polymedix' site is gone, but here's a link to their investor presentation: Novel Therapeutics for Infectious Diseases and Innate Immune Disorders

Tails,

There is some risk with Brilacidin. I was a heavy investor in Polymedix and in it at the time management blindsided us with PMX-60056 blood pressure problems. Since the two products are fairly closely related, concerns are valid.

That said, there didn't appear to be any similar problems with Brilacidin P2a, but who knows? In many of our (PYMX investors) minds, management withheld material information regarding PMX-60056 long after they knew of the BP problems. In fact, the announcement of trial discontinuation was the beginning of the end for the company, as well as the trigger for numerous lawsuits.

Many of us wondered how a product (Brilacidin) that had so much potential and displayed supposedly superior efficacy to its competition could not be picked up by a major pharmaceutical. I think a number of us were quite suprised to see a small biotech like Cellceutix buy Polymedix' assets for such a low price rather than a big pharmaceutical. It makes me wonder...

Is that the same samjennings007 who keeps speculating about a buyout?

Click on the poster's name and it will bring up a menu. Click on the "Ignore User" link. I believe the limit is five "Ignores" for free accounts.

How would you know when to file a "formal complaint" about a post from a poster whom you have placed on ignore?

Covered your shorts?

Possible reason for PPS drop:

I wouldn't be surprised if a future filing revealed that Frank dumped shares after his ouster. Despite Biotech Sage's article and the new CEO's statements, that would be an even greater contributor to PPS declines. It could also be the basis for a lawsuit due to his insider knowledge. Time will tell.

Securities lawsuits don't need a lot of basis. I've been involved in one and resisted getting involved in another due to my estimation (since confirmed) that it would get nowhere.

The first was a class action against GE. The basis for the suit was that the CEO "misled investors by issuing false and misleading public filings and statements between September 25, 2008 and March 18, 2009..." Essentially, the CEO stated GE would not lower its dividend numerous times, then lowered the dividend. The settlement is $40M, less costs and fees. Nearly 7 years after the debacle, I'll likely collect pocket change - GE has millions of investors.

The other company was PolyMedix, which is now in Chapter 7 bankruptcy. The CEO ran the company into the ground and by the time he was ousted, there wasn't enough money left to continue operations. The new CEO and BOD tried to get the company uplisted (sound familiar?) by reverse splitting the stock and a public offering but the investment community wasn't buying it and the company defaulted on a $6.8M loan and had to file for bankruptcy. At that point, whether there is any progress on the lawsuit, the company has no funds to settle it.

All this demonstrates that shareholder lawsuits rarely work and even when they do, only the attorneys make any real money.

Will there be a lawsuit against Invivo? Very possible. Frank withheld material information when he stated the 5-patient trial would commence in Q3-2013 and would be completed by the end of 2014, with success bringing sales by 2015. He obviously was aware of the FDA's requirement to stagger the implants over nearly two years and, although he alluded to possible additional FDA-required trials, he made it sound as if that might not be necessary if the 5-patient trial was successful. There's the lawsuit basis right there.

Not bashing, just being realistic. The point is, if they were doing all 5 implants nearly simultaneously, the failure of one would not halt trials, barring a catastrophe. Let's say though that 3 of 5 would be succesful. That's still a great improvement from current nonexistent treatments and reason to continue development.

However, if the first implant is one of the two unsuccessful ones of five, it's possible that would effectively end all trials.

Keeping a balanced perspective is fine but if commercialization is now 5-6 years out, a lot can happen in that time. What if the first implant is not successful, or worse yet, does more harm than good? Do you think the FDA will even allow a second, much less a third, fourth or even fifth?

Also, although there may be some positive aspect to spreading implants over a 21-month timeline, it will not do the company any financial good. They will almost definitely require additional financing just to stay in operation, most likely dilutive.

"When has this company ever done anything on time and/or as "announced"."

Let's see:
1. They announced submission of the updated IDE to the FDA on 2/28/13 and received Humanitarian Device designation on 4/4/13 and approval for trials on 4/5/13.
2. They announced the warrant exchange offer on 4/8/13 and the subsequent rise in PPS allowed them to call warrants, raising $16.1M and removing one impediment to uplisting.

And that's just in the last year.

I doubt he'll stop selling until he's sold 50% if the shares were divided up in the divorce decree.

chirotom,

At some point we just have to trust the company and assume that their pre-clinical work is valid. Although skepticism is a healthy thing when investing in stocks, this company has some very talented and peer-recognized professionals running the show who would have too much to lose if their publications were proven to be faked.

In the end, you have to do your own research and come to your own conclusions as to the validity of this company and the likelihood of its success but I haven't found anything during my due diligence that would lead me to believe everything is not on the up-and-up. Obviously, biotech investments carry high risk and there's no guarantee Invivo will be successful but that was true of many biotech companies that are successful.

Understood. Basically, it doesn't matter whether a poster is long or short-biased as long as their discussions are civil and they provide some reasoned discussion.

What you're ignoring is that the PPS also went from <$4.00 to a peak of $6.50 in 13 days, primarily on the uplist news. Since the uplist postponement, it has drifted back to its base pre-news. Fundamentals remain and the baseline remains.

So, what I get out of this is that you were among the peeps who thought you would make a killing on the uplist alone and sold out when it was postponed. Sorry your quick trade scheme didn't work out for you but that's what you get for not looking at the entire picture.

Who has lost faith in management? You think you speak for the entire stock market? More like a market of one!

Look closer. I guess you missed the "Passing" / "No Passing" tatoo on the monkey's butt cheeks.

I may be wrong but would assume that if the issue is with the Board, the uplist would have to wait until they can seat new Board member(s). I have to wonder if they can do that before the next SH proxy vote? I doubt they want to pay for a special vote.

Insider trading has little-to-no bearing on NVIV's PPS. The CEO has been selling 12.5k shares per day out of his 12.5M shares but that is due to a divorce and not because he doesn't have confidence in the company. No other recent insider activity.

In actuality, there are a number of factors in the recent PPS climb. One would probebly be ONVO's uplisting to the NYSE MKT. NVIV is just about ready to follow that same path (or to the NASDAQ CM). I believe that at least some of the price and volume surge is coming from ONVO's PPS increase (from <$4 to nearly $7 in a week).

But there are other factors as well. NVIV's initial clinical trials should start by early fall and their scaffold for SCI will not require the amount of testing that pharmaceuticals typically do. And their hydrogel products will also probably be fast-tracked. They also shouldn't require capital infusion (read dilution) for at least a year, if ever. That's a huge plus.

So you have a company with more than a year's capital in the bank, with a product that may see approval by late 2014-early 2015 and others not far behind. What's not to like?

Nope, I'm very secure in my 100+% profit in this stock (with more to come). I just have to wonder why you would claim the SEC would suspend NVIV since they're just about to up-list and have all of their financial ducks lined up.

What, exactly, does a psychological analyst for stockbust do, besides stirring up trouble on message boards?

It's up online now at Tech Take Live 6/27/2013