What a vacuum cleaner of a stock. It just keeps sucking up money from me. Left this AM for a long hike and I get back and see $1.69. I'm a buyer tomorrow. I never thought I would see this.

While I think DF will be part of the announcement I hope it doesn't get announced concurrent with a journal article. That will mean we will have lost a lot of time. First, someone has to write the article and that is a demanding task. Then, the best journals are peer reviewed, which means the prospective paper will be sent to other experts for a critique. That takes a while. Then it has to be accepted by the journal and published. All of this takes time too. Meanwhile, assuming efficacy, people are sick that could benefit. Also, later phase trials are delayed while a journal article gets published.

I hope DF and the company give a preview announcement of results and the docs can mess with the fine detail in a journal publication at a later date. There is an audience for the detail but hopefully that will not prevent announcement of results, the data going to the FDA and progress being made on getting the process underway for subsequent trials.

58 thanks for the response - I think Aspire is in it for a lot more than 15% too and I think this is one way they could get there. Under this scenario they may get 15% on a hundred thousand shares or so. My thinking was that the 100 share lots with a 15% gain are a small price to pay to keep the price down if the payoff is that you get millions of shares from Leo at a low price. As I see it Aspire would still have most of their 5 million shares for the big payday and would have paid a lot less for them by stifling a run by selling into it with 100 share lots. Many 100 share lots trades are being made.

This may or may not be a strategy Aspire uses. But I think they could if they wanted to. If Aspire does nothing they risk the share price running and getting a lot fewer shares when Leo comes calling.

All speculation but anyone with 5% of the float can mess with the SP if they choose to. By 100 share lots or other ways. I simply was trying to connect the dots since Aspire would definitely like the SP low when Leo asks for $. If you agree with that then it is logical to ask how they might do it. This seems to me to be a way but there may be others as well. I am not wed to it. Who knows - maybe they have just got lucky and the share price drifted down allowing them to get their shares at good prices. But I for one have been a little mystified by the price action. MMs are put out there by some, others suggest CTIX isn't known, others feel we need a stronger catalyst to propel the price or maybe a combination of all these. My post was to suggest another possibility into the mix.

One last thing 58 - I do not think my logic assumes Aspire is the only financing. In fact I mentioned that I thought Aspire may play itself out soon but then we would need more financing. That is based on the fact that once Leo gets all the money from Aspire, they will complete all their low share price purchases and would want the price to run. Whether it would or not may well depend on the type of deal Leo gets for the future financing.

Still messing around in the detail of the 10K. Here is something that is interesting:

Through June 30, 2013 Aspire had acquired 2,712,208 shares garnering $4,382,000 for CTIX. That is an average of $1.615 per share.

From July 1, 2013 through Sept 6, 2013 Aspire acquired another 1,800,000 shares resulting in proceeds of $3,200,000 for CTIX. That is an average of $1.777 per share.

The weighted average cost of those Aspire share acquisitions is $1.68/share. Those are attractive buys for Aspire given the time period when they occurred. But that does not include the shares provided at the start of the agreement. Those were 336,625 at no cost (a commitment fee) and 112,208 shares for $100,000. With these additions the share count is 4,961,041 at an average share price of $1.54. The total proceeds to CTIX is $7,682,000.

Aspire has (or has at one time or another controlled) 4,961,208 shares, or close to 5% of the float. We have no way of knowing how many they still have. They may have contributed to weakness by selling some at key times. Most of the time the share value has been well above where it is now, for a good stretch over $2. They might have taken some profits, or as I speculate below, contributed to weakness in another way.

So how might have Aspire played this and how might they do so going forward? Here is one possibility: they can exert quite a bit of pressure on the stock to get a low price when Leo goes to get $ from them and may have done this for their acquisitions up to now. They need only sell 100 shares at a time to negate big buys that might drive the price. It is always the last price that drives the ask and it is not weighted for volume. It is easy to move it down with 100 share sells at the market. They know Leo needs the $ so that would be my strategy if I was them. Leo is able to dictate when they buy but Aspire can hold the price down for a long time with that many shares. Then when they get all their shares cheap they can let the price run again.

They know the potential of CTIX. They can sell a pittance of shares at a time to get the price where they want it and then wait for Leo to call.

I have no problem with the Aspire deal. I just have been trying to figure out the price action. There is no way to get from here to there for nothing. But in my view those Aspire folks are doing just fine on their end of the bargain. As things move forward it is my firm belief that we will too. The good news is there is not that much more of the Aspire funding left so this will play out soon. Once Aspire has their position complete (assuming they want to hold) they will want the price to run. The flip side(not bad, just necessary) is that something will need to replace it.

Any of the big catalysts would end all of this.

These are all speculations on my part but seem consistent with some of the anemic and slow downward drift in the price action. Comments?

Interesting to see the transparency on the Canadian exchange compared to U.S. The last 25 trades for SPIHF (ANY)are listed at the bottom of the ANY page. When you place your cursor over the buyer or seller you can see who it is. Each is assigned a consistent number. I take it that #01 for anonymous is all of us little guys lumped together. The firms that are trading are pretty consistent. Sometimes one firm is both the buyer and the seller which is really strange. I guess when they do that they are just pushing the volume but it still seems weird.

Anyway, I just got a fill for another 3900 shares at 3.10. GLTA!

I hope so Cabel. But the patent wording seemed narrow - psoriasis, seborrhea, eczema. There may be enough wiggle room in the phrase "but not limited to" but it doesn't seem the claims were nearly as aggressive as with K. I guess we will find out some day.

Thanks for posting this. We used to have a notion on this board that we were alone in an oral treatment of psoriasis. That is not the case as this med is oral and there are several more in development. I posted a chart showing this a few weeks ago. So that advantage is becoming less so all the time. The competition in psoriasis is substantial. The key for Prurisol will be efficacy. These results are good but the animal data suggest that P may be better. It is time to find out. Also, I noted the side effects and my hope is that P will be better on that count too. We need to get the trial started and see what we really have in P!

Nice Buzz from the Toronto Exchange.

http://www.smallcappower.com/posts/article-top-momentum-gainer-3-10-2013

Nice little article on the Toronto exchange featuring Sphere 3D. This type of news attracts momentum players that can add to the SP. The stars are lining up on this one!


http://www.smallcappower.com/posts/article-top-momentum-gainer-3-10-2013

Yes it is accurate. I owned the other 2 but never took a bite here until today. It was offering at 1.37 so I put in a limit order at 1.36. When I came back it had filled at $1.20 - all 7000 shares. I was stunned to say the least. Saved me $1120. All I can say is thank you MM and I don't do that often.

Not the same. The bridging study was a laboratory based study. The PoC was to have been with use in humans.

Funny you say that. I don't follow my logic either. I went to bed last night and started thinking about what I wrote and said "What the ---- was I thinking?

Yeah, but not bad for CTIX if they decide they want to have Aspire buy up the shares they are still contracted for in the financing agreement. Wouldn't you rather have Aspire get shares valued at $1.80 than $6.00? CTIX can then secure the rest of the $10M ($2.4M left) for a lot less. Ultimately if CTIX is successful and Aspire continues to hold, they will get the $6 but at least would face the same risk we do in getting there.

I think CTIX should probably get ready to do this as the shares are cheaper and the benefit of $2.4 M is the same. We know they need that money from the 10K so it wouldn't surprise me if they move on it soon with the share price a little lower now.

I don't think it will be large in a relative sense. They will need $8 million for the next 12 months without Poly M. They have $3 million but they will not take it down to $0. They also have $2.4 million they can get from the current Aspire deal. Another source of funds that would take awhile to figure out via the spreadsheets and notes is the $ that come in from exercised warrants. Consider this quote from pg. 34 of the 10K:

"From July 1, 2013 to September 9, 2013, the Company issued 825,000 Class A common shares par value $.0001 to a warrant holder upon exercise of Common Stock Purchase Warrants exercisable at $1.00 per share. The Company received an aggregate of $825,000."

When warrants are exercised the $ help operations but can contribute to a softness in the share price if the person decides to grab some profit. We might be experiencing some of that among other possibilities already noted by posters.

So the 10k states they need $5million PLUS whatever they end up budgeting for Brilacidin or anything else picked up in the Poly M deal. Seems another $10 million type deal like Aspire would fit the bill. That would get the company down the road a bit. The other possibility is some kind of partner but I hope they can hold off. The more advanced the trial the more valuable any partnership will be.

That is the truth. When you have a little softening of the price people tend to focus on the risk of being in the stock. But it is important to remember the risk of being out of it. Nobody knows when something significant may happen.

Finished first read of the 10K; Key points:
1) We have all the PolyM patents. I recall some discussion of this awhile ago.
2) Reiterated no trace of adverse events with K and that it is at 7.5 times the dosage it started the trial.
3) Budget for next 12 mos. $1.5 M for K, $2.5 M for P
4) Reiterates P 21 finding at low doses.
5) Now has 9 employees
6) Will use $8M in next 12 months
7) Have $3M in cash as of June 30
8) Work will no longer be done by Kard but by CTIX employees.
9) Up to 1700 shareholders
10)Discussing clinical trials with other institutions and also in discussions to acquire a new drug
11)2 material transfer agreements pending with major hospitals.
12)Have $2.4 M left from Aspire financing deal
13) Need about $5 M (excluding Poly M) and will attempt to get it from capital and debt financing
14) Better accounting needed per auditing firm
15) No independent BOD members picked yet

Form 10K available

Just now I see that Cramer is recommending PC_C. After it has gone up 125% YTD and 1577% over past 3 years. If everyone comes to the party that late a lot of the big bucks are already made. Of course not everyone comes to the party that late do they? I like to think that we are the PC_C folks before the 1577% rise, not Cramer's hoard that will now jump in for a few bucks. Remember less than 4 years ago you could buy PC_C for $1.85. Today = $135. Will CTIX do the same? Time will tell. But sometimes these types of dreams do come true.

Macnqueso - I have been thinking a bit about all the trouble you went to give us some fun numbers to think about for the future value of CTIX. Without going into a real sophisticated model of valuation I thought it might be fun to use your numbers to come up with a gross theoretical value for CTIX stock TODAY. We all feel we are undervalued so what might the numbers suggest? The example I am laying out here makes some big assumptions too. But it is all just for fun.

I am going to use the first example from your second post (post 42290) which was the model for K with a 10% market share for just one type of cancer, i.e., lung cancer as follows:

700 million in gross rev
40% profit margin = 280 million
less 50 million in operating expenses = 230 million
P/E ratio of 20 = 4.6 billion market cap
150 million fully diluted = pps of $30.67

Assumption 1: this took 5 years from now to accomplish.
Assumption 2: we will use a discount rate of 7% to derive a present value of the PPS based on the 5 year timeframe of assumption 1.
Assumption 3: we will use the success rate for a Phase I drug candidate as another discount to the PPS. I noted some figures from the Tuft's site the other day. A Phase 1 drug has a 16% chance of making it to a full fledged marketed drug.
Assumption 4: this is a big assumption and that is that K ultimately succeeds as your modeled value suggests. Obviously it could fail and Assumption 3 illustrates that. If there is a failure all the numbers go upside down. But the idea is like a post mortem of a completed process. Think of it like this -Since K succeeded what should the value of the stock have been 5 years ago for this one type of cancer that now has 10% of the market?

Okay, now for the formula and numbers of this simplistic model:

K PV = Future PPS x 5year discount rate at 7% x likelihood of success.

or

K PV= 30.67 x .6209 x .16 = $3.04

Just another way to look at this although there are many loose ends here. Maybe the time value of money should be higher that 7% etc. But on the optimistic side I think we are far enough along that the 16% is likely higher and you based your model on just one type of cancer. Of course, B would have a higher figure used in Assumption 3 as it is the furthest along. And if P starts up in a Phase 2/3 as indicated, so would it. The point then is that if we were to put some reasonable numbers on all these drug candidates based on their progression through the trials, the current PPS is anemic compared to where it should be. But I guess we already knew that.

A conversation with my wife just now -

Me:I am going to go in and see how CTIX is doing.
Wife: Why?
Me: We have a lot of money in it so I need to monitor it.
Wife: Why?
Me: What do you mean?
Wife: If it is down a few pennies you will want to add more and you already have committed more to this stock than intended. And if it has gone up a few pennies you will say it is just getting started and you can't sell now. So you have no need to monitor it.

Hmmm....Maybe I am the one who should have made my name I Need Help.

Am fully loaded but grabbed another 5k this AM. Keep lowering that average!

Looks like a non-issue. See this quote from The OTC site:

The OTCQB marketplace has effectively replaced the FINRA operated OTC Bulletin Board (OTCBB) as the primary market for SEC and bank reporting securities that trade off the exchanges.

It seems Tufts University is the center of the universe for all things related to the drug development process. Last few days I have been poking around the Tufts site. I do not subscribe but was still able to find some interesting information that is available to all free of charge:

The FDA has made an effort to decrease the approval time for new drugs and has succeeded in decreasing it to 1.1 years for the period of 2005 -2007. However, clinical time has increased so that the combined clinical and approval time was still around 8 years.

The cost of bringing a new drug to market continues to increase from $800 million to as much as $1.2 billion now with some allowance for different classes of drugs.

Data from 1999 -2004 of the 50 largest global pharmas show the success rates in transitioning between the different phases of drug development. Phase 1 to Phase II - about 65 % of drug candidates make the transition. Phase 2 to Phase 3 about 37%. Phase 3 to NDA about 67%. NDA to NDA approval = 100%. This leads to an overall success rate from Phase I to NDA approval of about 16%.

B is our most advanced candidate and by this approach is a very valuable part of the CTIX franchise. I do, however, seem to recall Dr. Menon messing around with K in preclinical for something like 6 years so I suspect it has much better than average prospects to make the transition than the percentages we see for big pharma. And now P will advance quickly as well and it is derived from a pro drug that should up the chances for success.

The averaged numbers are a little bit of an eye opener. Drug development is a risky play but the payoff can be huge. I trust that our team is better than average and we will reap the rewards of their expertise and collaborative relationships.

If anyone is interested the link is:

http://csdd.tufts.edu

Whether CTIX is subject to MM manipulation is probably not the question. But it is undeniable such manipulation has existed and probably will in the future. Some have been litigated. Knight (NITE) has had to pay the piper in the past.

The curious thing to me is the ability of the MM to trade the stock in one branch of their company while being the MM for the stock at the same time. Talk about a conflict of interest! This had led to cases of front running where the MM can time the trade of their securities based on what the little guy is doing in the same security.

I watched Aegis on the day of the recent NVIV debacle rush out a buy recommendation for the stock predicting a price of $6 to $7 for the stock while it was crashing. Why might they do that? Aegis was the MM for NVIV. Anyone who thinks the Aegis equity arm did that independent of the Aegis MM arm is never going to sell me anything.

Coordinated activities of MMs to defraud investors was a litigated issue on the Nasdaq in the 1990's. Things have been tightened up but these are clever people. If the past is any indication I do think some MM firm (not all) would defraud investors if they felt they could get away with it. Or even if they felt the fine might not outweigh the reward.

Finally, on the issue of just doing their job which I think Pete mentioned. I think some of these people have little conscience and view these types of manipulations as their job. I read an interesting article by a wall street guy who said if they did functional MRI scans on the brains of the people on wall street it would show antisocial behavior to down right psychopathic behavior in about 90% of them. This is a cheap shot with no backing but after hearing that guy at Goldman's declare they were just doing God's work in the bundled derivative business it does make one wonder.

No conspiracy theories needed here. The track record is there and last time I looked greed still exists.

Thanks BK

Could a mod please add the new patent application to the web site? At least as a sticky. I will be needing to look at this from time to time and do not want to have to go back to find TPs post. TIA.

TP - That is a really interesting find. I have been looking it over a bit but do not claim to fully comprehend what the addition to the original patent is all about. I offer these observations:
There were 48 claims in the original patent and this new document adds 20 claims. There seem to be an emphasis on "method of treating" for the first 11 new claims. Some of these are for items in the original patent that covered a "pharmaceutical composition" but did not do so for a "method of treating" from what I can tell. It is interesting that the original patent did get into the method to treat starting on claim #20 for compound #45 but did not do so for claims 1-19 which are all nested to refer back to claim #1 of the original which, in turn, are all based on compounds #36 through #44. The original patent also did not specify a method to treat starting with claim 37 for compound #53. Anyway, for what it is worth this may be an attempt to patent the method to treat for the compounds noted in claims 1-19 of the original patent.

Then we come to claims 12 through 20 in the new document where the emphasis switches from "method to treat" to "pharmaceutical compositions" and "compounds". I haven't looked at these too much vis a vis the old document. Maybe some new chemical compositions?

I am no expert but like to look at complex documents to keep the brain cells firing. I would be interested in anyone who has other observations regarding this important find by TP.

That is twice that Leo has singled out Crohn's. First time in the second PR. I did a little digging on Crohn's and it falls in that immunity area where the defensins play such a key role. It was surprising to me to read that good hygiene in youth seems to be a precursor to the development of Crohn's. That is right - GOOD hygiene. If you come from large families where toilet facilities are shared etc. the chances seem to favor you will not get Crohn's. I guess the immune system needs a little insult when young to build it up properly. Strange. I guess we all need a little dirt in our lives! LOL!

The defensins also play a key role in cancer, specifically in the immune system again. There are companies working on this. Who knows maybe Dr. Menon can be cloned so CTIX can start looking into that too!

The more I poke around on what PolyM was up to the more impressed I become. I do not think this was just a steal. This was a record setting heist of intellectual property that I believe will play out for many years and for a number of pathological conditions. I think we need to stop thinking of this an antibiotic acquisition. Instead, this is a foray into a broad range of immunologic applications that will keep this company humming for years. And that says nothing about the many iterations of K covered by the patent. This company has so many interesting compounds and potential areas of investigation it makes your head spin.

Pete what you have touched on is the opportunity cost of the decision to not acquire the assets. Most on the board understand the concept but here is a brief definition for those who may not:

http://en.wikipedia.org/wiki/Opportunity_cost

Put yourself in Leo's shoes. He has this opportunity or not. The cost of the null is likely quite significant when approached as an opportunity cost. Ultimately, we do not know the final outcome of either option available him at the time (buy or not buy) as both are subject to assumptions, value assignments and many hurdles to ultimate success.

One way to look at this is to ask yourself the following question:

Leo had the opportunity to get Poly for $5million but didn't do it. Are you happy? If you are happy then you feel the $5 million had a better use and the associated risk/reward profile adds to the $5 million figure to some extent. On the other hand, if you are not happy then you feel the acquisition was a better use of the money than the plan before acquisition and any risk is outweighed by potential reward.

There are models for quantifying those risks and rewards which, include the timing of the acquisition. This type of opportunity presents itself when it does so the timing cannot be negotiated, it just is. The key to all this, as my business professors always use to say when you assign value to risks and rewards, is it all depends on your assumptions.

It is not a big reach to turn speculation into assumptions. We have heard the speculations - something may be wrong with P etc. Have those become the hidden assumptions of some? If so, they will likely model the risk as higher that others. Informally this is going on with the posts I see on the board. Leo went through a much more rigorous and formal analysis of the same factors and made his decision. I can live with that.

Looks like Daptomycin has a little bad breath of its own.

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220273.htm

In addition to BKs post, recall that Cellceutix was chosen to be a Stalking Horse. That potentially puts them in a very favorable position vis a vis other bidders. It is not just a regular auction. In adept hands a Stalking Horse can position themselves in such away as to make it very hard for other bidders. The key is to walk the fine line between the provisions the Stalking Horse negotiates and what the bankruptcy court will accept. See the following attachment which outlines some of those advantages.

I have no doubt that Leo, with help from the legal expertise available him did an excellent job in this regard.


http://www.jonesday.com/newsknowledge/publicationdetail.aspx?publication=2177

Ovidius - I took that for religion too. That was why I was surprised to see this:

http://www.psoriasis.org/research/drugs-in-development/pipeline

I do not know what to make of the oral space any more. Also, P is not on the oral list but that is probably because there is nothing but preclinical data for P whereas all the others are deep into trials.

Polkadot - I feel the same way. I live in a beautiful place and went out for a rather strenuous 7 mile hike in the mountains today , found 3 Indian ruins I didn't know existed and enjoyed the day. I came home and read all the posts but it pretty much was the same as yesterday. I guess each has their view and I know how I feel so I am posting less and spending less time on the board. As we move on there may be more useful discussion again and I will up my involvement. I will be around anyway because I need to know if something breaks and will no doubt want to participate when those events occur. But I do not find the current discussion of much use. I've got some other stocks I am looking into anyway and will spend my time on them. The DD on them takes a lot of time and energy. One observation: there has been an increase in hostility on this board since the conference that is quite marked from what preceded the conference. I guess unmet expectations spilled over in ways that are a little less than desirable. It has kept the mods busy!

Rainy day where I live so I decided to spend it poking around on the detail of the acquisition. On Slide 5 of the presentation, which was the lead off slide for the acquisition, Leo listed what was acquired. First noted were 10 compounds. The second item was a "proprietary computational drug design technology." Hard to divine what this means exactly but the indications are that the proprietary technology is extremely valuable and efficacious (we all like that word) as evidenced by the sheer number of promising molecules. And what an impressive list of targets for these molecules - anthrax, malaria, fungal infections, TB, food borne pathogens, anti-coagulant reversing agents and of course the bacterial infections that Brilacidin targets(staph aureus, blood stream infections, lung infections and oral mucositis).

Some posters make the case that B is a play to partner and get money for the company. That may be....or not. My point is I do not think this is an acquisition that was done just to facilitate up listing or to bring P and K home. I think it will help with all that and that is a great thing. But it also appears to be an incredible technology and library of molecules that stands on its own science and opportunities. Remember this company was more embraced by the market and had a value exceeding that of CTIX which, subsequently was squandered by inept financial acumen.

We are in a period where the company must digest its new makeup and so must we. It may require some patience and shifts in our expectations as evidenced by the new plan for Prurisol. There may be resource constraints (capital, employees) that need to be worked out. But L and M have more to lose than anyone and felt this was the way to go.

I think it was revealing that Leo started his presentation with the anecdote about the father wanting his son to pick him up at the airport. Why was that the leadoff? Maybe it is as simple as the ending to that little story. Leo said his job wasn't to tell us he loved us, it was his job to move the company forward. If that means Prurisol has a shift to a new approach, so be it. If that means people think management has been distracted or lost focus, so be it. He and M have more at stake, more info, more expertise and a proven record of improving shareholder value. Seems to me they are moving the company forward in a dynamic way. Maybe PolyMedix told their shareholders they loved them all the way to bankruptcy. I'll take this approach.

I have worked closely with 4 CEO's of a billion dollar enterprise and observed a little of what makes them tick. What they do is not always liked or their actions popular. But all 4 of them were successful and kept the enterprise moving forward. When all the hoopla dies down it is my belief that will be the case here. GLTA!

This sounds good. The government is actively promoting the development in this area.

GAIN Act

To address this issue, the GAIN Act will provide incentives to increase the commercial value of innovative antibiotic drugs and streamline the regulatory process so that pioneering infectious disease products can reach patients. “Incentives for research and development and fast track FDA review are needed to stop these bacteria and infections from spreading,” Blumenthal asserted.

The bill would extend the exclusivity period for new qualified infections disease products by five (5) years. This extended period will be in addition to any extension for pediatric exclusivity. The legislation would not apply to supplement applications for presently approved drugs, a change that results in a new indication, or a modification to a structure of the product. The bill would also give a product an extended 6 months of exclusivity if the sponsor or manufacturer identifies a companion diagnostic test.

The bill instructs the Secretary of the Department of Health and Human Services (HHS) to create regulations to implement this legislation. The legislation sets out specific definitions of which products will qualify for the extended exclusivity period. If a product is determined to fall within the recognized category, the HHS Secretary will have the discretion to give it priority review.

Additionally, the legislation asks the Comptroller General to conduct a study on the need for incentives to encourage the research, development, and marketing of qualified infectious disease biological products. It would also instruct the Secretary to review guidelines for conducting clinical trials for antibiotics drugs and revise them as necessary.

The bill was referred to the Senate Health, Education, Labor and Pensions (HELP) Committee. The companion House Bill, H.R. 2182, was introduced back on June 15th, by Phil Gingrey (R-GA) and Diana DeGette (D-CO), and has nineteen (19) co-sponsors. The House bill was referred to the House Energy and Commerce Committee, Subcommittee on Health.

"Drug-resistant infections in Tennessee and across our country are posing an increasing threat to public health, and the federal government can play a constructive role in helping spur innovation of new drugs for treating these conditions. Without putting any federal dollars at stake, our bill provides meaningful market incentives to encourage development of new antibiotics that will help save lives and reduce health care costs,” Corker said. “By strengthening this segment of the market that currently has only a handful of new drugs in the pipeline, we can help ensure Americans at home and our troops abroad have access to treatments capable of combating these deadly infections.”

Sharon Ladin, Director of the Pew Health Group’s Antibiotics and Innovation Project commended Senators Blumenthal and Corker for their bipartisan leadership. She noted how, “The bill creates incentives to spur antibiotic innovation and brings us one step closer to delivering new, life-saving medicines to the growing number of Americans who urgently need them.”

The GAIN Act has been endorsed by 39 groups, including the National Military Vets Alliance, American Medical Association, St. Jude Children’s Research Hospital, and Children’s National Medical Center.
- See more at: http://www.policymed.com/2011/10/generating-antibiotic-incentives-now-gain-act.html#sthash.637kDWbJ.dpuf

I read his SA articles. He is very thorough in his analyses. I am glad you are talking it up with him. If he does his DD and comes out with a favorable article it will help the SP IMO. Of course we all await the next article by Karin and TP too. Seems like they have some ammo for a good one!

From the study:

Primary Outcome Measures: •Maximum Tolerated Dose (MTD) of Kevetrin [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]

A dose will be declared the MTD if at least 1 patient out of 6 patients experience a dose limiting toxicity (DLT) at the highest dose level below the maximally administered dose. Once an MTD has been established, up to 12 additional patients may be enrolled at the MTD dose level for confirmation of safety.

The maximally administered dose is if 1 or more of 6 patients experience a DLT.


•Dose Limiting Toxicities (DLT) of Kevetrin. [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ]

The definition of dose limiting toxicity (DLT) is in accord with the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Dose limiting toxicity will be defined as:
?Grade 3 or 4 neutropenia complicated by fever, or greater than 38.5°C documented infection, or Grade 4 neutropenia of greater than 7 days duration
?Grade 4 thrombocytopenia or grade 3 thrombocytopenia complicated by hemorrhage
?Any grade greater than 3 non-hematologic toxicity unless there is clear alternative evidence that the adverse event (AE) was not caused by Kevetrin
?Grade 3 diarrhea, nausea, or vomiting may be excluded from dose-limiting toxicities provided that the maximum time limit

The good news is the definition of DLT was not the issue with the patient. Instead all the described DLTs above are in EXCELLENT shape with Kevetrin per the slides (see slide 10).

Okay, that makes some sense to me. I didn't think of the link going to the website and picking up the new info. I rest my case!

To me the size looks the same but it looks like it is in bold.

I guess I am the only one still having any issue with the change in slide 9. Noretreat posted he was reviewing the slides at 8:39pm (post40062). At 9:06 Sox made the first posting of all the slides (post 40069). The p21 reference was on slide 9 of the Sox posting. Not doubting what you are seeing on your screen and what others state. Just trying to get to the bottom of how and when an update occurred. Any update would have occurred between those times unless I am missing something. How did all the people see this in the 27 minute gap before Sox posted them the first time? Or could someone have doctored the 9:06 post by Sox on IHub? By the way there is a note on slide 8 that there was increased P21 expression in lymphocytes as well in the original Sox posting.