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January 24, 2013...
"Research by BIDMC combined Kevetrin™ with sunitinib on cell line 786, a drug-resistant renal cancer. Cellceutix was advised by the researchers that 'the Kevetrin/sunitinib combination is the first we’ve used in which actual tumor shrinkage is noted.'”
Spore grant with BIDMC in 2014 very exciting possibility...
Gov... thanks for keeping track of of it...
"We are a clinical stage company. We have no product sales to date and we will not receive any product revenue until we receive approval from the FDA or equivalent foreign regulatory bodies to begin selling our pharmaceutical candidates."
As Dr. Menon stated... money is not an issue... this is very rare among developmental stage biotechs... it is rarer still among those which are about to initiate 3 brand new p2 clinical trials in the next QTR...
"acquiring a new drug" - 18 not enough??? anyone else think the veterinarian is having a good time in his lab (playground)... 18 now working on 19... way cool...
I have much less than 25 years... and am counting on just what you said to come to pass... may it be so...
zero is the downside extreme... zero, nada, bupkis... there is no guarantee in developmental phase biotechs... i am in deep too... way too deep... so deep i can't afford not to ask "if"...
lol... you're right... i didn't specify which digits... i meant the digits on the other side of the decimal...
His reply would be worth every bit as much as his original post... guaranteed...
You are correct... this is currently a pre-clinical indication... for those who understand what that means it is what it is... the fact that it is in the pre-clinical stage is the reason for the low volume, the low pps... and so on...
This is a risk/reward play... zero is the bottom of the risk... the potential reward is at least double digit pps... and maybe triple... in five to ten years... or perhaps a buyout prior...
The IND is the huge next step for it moves this from pre-clinical to clincal stage development... 2014... IND... initiation of P1 trial... that's all that really matters... it is the only thing that will truly move pps... eyes on the prize...
if one ignores the noise and looks squarely at this company... what is evident is an excellent... imo... risk vs reward value play... the company made structural changes this year and recently moved into new digs... has an intriguing diagnostics division which is working with BD towards possible monetization as early as late 2014...
then there is manf... which may be nothing or may be an incredibly diverse revenue generating treatment for many indications or something in between... there is plenty of research material already to support continued study of this intriguing entity...
there is far too much dilution... albeit understandable dilution given the need for funds to move research forward... there is an intriuging catalyst for 2014 in possbile filing of IND... there are special designations such as fast-track and orphan which may be pursued...
so bottom line... here is the risk/reward... you risk everything you put into this stock as zero is definitely a possible outcome down the road... and you risk it in exchange for the possibility that it will return x10 or maybe even x100 in the coming years... jmo...
"Essential news won't come out during the next weeks"
My apologies as given your reply you intended to say next week's... as in next week... and did not intend to say 2 or 3 or more weeks... I was hasty... sorry for your stomach ache... never eat a crystal ball unless it is covered in chocolate... and always remember to use the apostrophe when conveying "next week's" otherwise it may be misinterpreted... awww... now you've done it... you turned me into the punctuation police...
So in the end I agree with you... in the absence of material news the downward trend will likely continue... material news may come pretty much whenever and then again it may not come then... I am invested in AMBS because my valuations indicate the potential rewards are many multiples of the risk... the weeks, months and year ahead... will be interesting... good luck to you...
and how precisely would you know whether or not news will "come out" in the next weeks? it may or it may not... but how would you know... crystal ball?
I agree very much with this post... although I do not expect PRs like these to move the markets or drive the pps... I do believe they are very important to us investors and they send a message to perspective partners...
In hindsight... it has become clear that the Polymedix acquisition was a dominoe in a long and intricate design which signals a major strategic shift... hints of early signs of efficacy for Kevetrin... tbe development of Brilacidin... the change in strategy regarding Purisol... the increase in manpower and the organization into teams to do some of the CRO work... the shift of Dr. Menon to "full-time" status... the 20 mil financing with Aspire... the November partnering conference... the re-statement of plans for uplist... the change in the clinical trial website for K... any of these taken alone might be interesting in and of themselves... but when taken together create a remarkable tapestry... a significant transformation is underway at CTIX...
Performing reasoned and well-articulated valuations for CTIX will get you branded with the "irrational exuberance" tag every time...
The market views this as a forward looking statement... because in fact it is a forward looking statement... as such it is unlikely to drive volume or pps... material announcements are needed to drive pps... these would include such things as...
- specific events related to the initiation of clinical trials for b, p and k
- data from the ongoing k trial
- partnership with serious upfront money
- actual activity leading to an uplist
so for example... "all necessary paperwork has now been submitted to FDA to initiate Purisol P2/3... answer anticipated from FDA in 30 days..." would be the type of announcement that might be expected to drive volume and pps...
while today's announcement may be meaningful to long-term investors... it does not represent an immediate step towards the monetization of a product...
Emphasis mine... please note the use of the word portfolio in the quote below... which indicates there is room for more novel MOA antibiotic indications... they are building a portfolio... this PR would indicate to me that Roche may be a real player for Brilacidin given their strategy in this area... I also think it puts pressure on other pharmas regarding this sector... there are not many novel MOA's for antibiotics out there... and in fact there is ONLY ONE... in P2 stage of clinical development... let the bidding commence...
“As part of our Infectious Diseases research strategy we focus on areas of high unmet medical need, where we feel we can make the most difference for patients. We are excited to partner with Polyphor as we build a portfolio of novel antibiotics,” commented Janet Hammond, Head of Infectious Diseases Discovery & Translational Area in Roche pRED. “As the incidence of drug-resistant infections is creating an urgent demand for new therapeutic options, we look forward to adding this potentially important, targeted agent with a novel mechanism of action to our portfolio of innovative medicines.”
imo... the last three announcements have been intended as much for potential partners as they have for investors... as such these may not be the prs that move the pps just yet... if so, so be it... Leo is saying very clearly... we are prepared for the long haul, we have the clinical and financial resources to advance Brilacidin through the regulatory process, and today's announcement is we understand the full valuation of Brilacidin... the message for future partners is clear... bring a valid offer to the table... this will not be the place to bargain hunt....
In this case the P2b trial is clinically indicated because of findings in the P2a trial... namely that Brilacidin is highly effective in very short dosing protocols... and not really anymore effective in longer dosing protocols... and the possibility that shorter dosing cycle will further reduce any adverse side effects, which are already quite manageable, but less of this is even better... so before launching into a very expensive P3 trial designed to achieve stat sig level of efficacy... it makes sense to do a P2b with shorter dosing cycle as confirmation of P2a findings... data from P2b will inform the trial design for P3...
welcome aboard... you are welcomed for your handle if nothing else... you will find this board to be an interesting ride... share what you wish... just don't expect it to be appreciated... no good deed goes unpunished or bad deed either for that matter... while some might appreciate... you may also get slapped around a bit... developing rhino hide is helpful... as for me... I will judge you by your track record over time... eventually I'll know whether or not you have a clue... BJ can be a bit grumpy... but he does have periods where he contributes important info... for me he is definitely a net gain... hope you will prove to be as well...
here are a few things those other guys have that CTIX doesn't...
pharma partner providing plenty of cash
institutional investors
listing on a major exchange
lead indication in multiple late stage clinical trials including adjuvant applications
sound familiar?
if CTIX acquires these things, then it is likely to run in a similar fashion beginning in 2014... jmo...
so to be clear... all investors should understand this goes to zero or close to zero... if B, P and K all fail in 2014... just sayin...
investors who are in today... at least get basis back... and likely a nice, tidy profit... if one and only one of the three succeed in 2014...
and if more than one succeeds... especially if one of those is K... then investors are looking at a multiple year run to 100 and beyond...
the product line here has significantly more potential than that other entity... but their product line is at a more advanced stage of clinical development... 2014 will be a critical year for CTIX...
No. They do not. Not even close.
That's precisely what I am looking at... go to FDA trials site and see how many clinical trials they have... in 2014 ctix will begin to look like that...
"I hope the reason is they are excited about unannounced K results but I don't see why this is necessarily the case."
my post didn't suggest anything about K... just agreed that i would love to have been a fly on the wall when Aspire was conducting DD under an NDA... in preparation for putting up 20 mil... as stated... whatever they saw... apparently looked to be worth it from their end...
yeah... wonder whatever happened to those ears???
For 20 mil... you get peek behind the curtain... apparently Aspire thought it was worth it...
"I would love to know what those guys were shown behind closed doors."
Me too...
Yes... so for those who stayed in the antibiotics game... it becomes even more inexplicable as to why they didn't jump on the Polymedix assets and instead let Leo have them on the cheap... if you are the person responsible for that can you really pass on the bankruptcy acquisition and just a month or two later make a case for spending 20x what you would have paid... and Leo's expectaction is likely to be at least 20x based on future valuations of brilacidin...
I agree with you that there is plenty of data... I just don't think any of those players can stick their necks out right now when it would confirm that a major miss occurred on their watch... I suspect they will need the next trial completed in order to save face... there are human beings and workplace dynamics to consider...
The Aspire deal is to give Leo time to do what needs to be done to secure a good deal for Brilacidin...
Here is one problem with Brilacidin... deep pocketed players have actually disbanded their anti-biotic programs for the most part... which is one of the reasons CTIX was able to sneak in and get it on the cheap... now imagine you work for one of these deep-pocketed players and with the GAIN act and the promise of Brilacidin... has the financial equation changed such that you want to get back in... maybe... probably not... and even if you do are you now willing to pay a significant mulitple over what you could have just acquired by buying Polymedix only a short time before... how do you explain that one to the execs and shareholders you answer to... we didn't think it was worth acquiring Polymedix for this, but we are now willing to pay 10 or 20 times that to acquire licensing rights to its lead candidate... doesn't make you look to sharp does it...
so for a deep-pocketed player to save face they will require a completed phase 2b with data in order to say... ok now more of the risk is removed... we were being careful, but now the dynamics have changed...
Leo will need to complete a phase 2b to get the return he wants on Brilacidin... that is why the Aspire financing agreement is important...
Nothing bad about it ... just triggered my curiosity... what a textbook example of mismanagement...
I doubt it ever actually hit $20 in a trading session... most likely that it as after the fact historical split adjusted number from a happier time in Polymedix history... The 50:1 reverse split adjustment appears to have occurred on Friday, March 15th after the close of business... the stock price closed at 5.695 on March 18, the first trading day following the split... it peaked a couple of time at $7 over the next two weeks including on March 29th... another Friday... then on April 1st Polymedix filed its 8-K for bankruptcy and the stock plunged straight down from $7 close on Friday to a Monday close of 22 cents... brutal...
LOL... you didn't have to steal it... I would have gladly given it to you...
A: follow the money...
find me another...
is there another developmental (pre-monetized) biotech company that...
-routinely burns cash slower than anticipated
-is on pace to have 5-6 clinical stage trials going in 2014
-has access to 26 million for pipeline development
-has a clinical stage trial ongoing at DF or other similarly prestigious leading research institution
-is able to secure financing on favorable terms and w/o using warrants to sweeten the deal
-is developing three distinct pipelines at once each with billion plus potential valuations
and if there is... what pray tell is its current pps... ???
In my view the last two PRs should be read as one... the message is loud, proud and clear... it is... we are prepared to see this through to the end if necessary... we have the expertise to do so and the resources... we do not need a deal to move product line forward... we are not vulnerable... we cannot be lowballed...
the bard is necessary for the investor's soul... even when, nay especially when unappreciated... lest we forget the human suffering embedded in this noble endeavor of CTIX
All fair and accurate points to be sure... the view of posters on this board re: CTIX are vastly different than the view of many other investors... and, of course, there are still other investors who do not even see CTIX yet and have no view of it whatsoever... time will vindicate those who are most correct in their assessments... 2014 I think will be a very important year in telling this story... by the end of it... I think the picture gains quite a bit of clarity...
Yes. Leo does not intend to sell any rights/licensing cheap... this financing guarantees he doesn't have to...
2014 is shaping up to be a remarkable year for CTIX pps... and the year just might begin a bit prematurely... we shall see...
Aspire knows enough to provide favorable terms on 20 mil... I agree with you a very good sign for retail longs...
excellent info George... appreciate you taking the time to share it with the board...
poly-heist indeed... watching the Frontline episode on super bugs... chilling, sobering, intense... check it out and then read this Brilacidin fact sheet...
http://files.shareholder.com/downloads/ABEA-4ITCYZ/1997024712x0x611205/FEA66C67-D02F-4FF2-B230-AA711F46ED7F/PMX-30063_Antibiotic_Fact_Sheet_Nov_2012_.pdf
a quote from the fact sheet...
"Our defensin mimetics provide potent, broad spectrum activity against multiple Gram-positive bacteria including MRSA, En- terococcus faecium, and Gram-negative bacteria including Eschericia coli, and Klebsiella pneumonia(NDM-1); all of which have become resistant to many antibiotic drugs."
and to think our CTIX shares now include the future valuation of Brilacidin... added for pennies on the dollar... poly-heist indeed...