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Frequently Asked Questions: Breakthrough Therapies
Interesting link: http://www.fda.gov/regulatoryinformation/legislation/federalfooddrugandcosmeticactfdcact/significantamendmentstothefdcact/fdasia/ucm341027.htm
BK, I enjoy your shameless legitimate pumping by request even. Thanks
LoL Sox, when I read the topline results PR all I could think of "was Leo go talk to the FDA" B 2b results are ripe for breakthrough. But I think Leo would have to have the hard numbers from the trial??? I know the company said it will presenting a poster over in Europe this coming April but one would think they would have the "bottom line" results before then?
I am not all disappointed with the current pps run. Some have posted something along the line of "what it is not $4-5". But if you think about it we went from 1.70 straight up to 3.00, first on anticipation of news results than later on Leo comments on the general observations of the B 2b trial. The information Leo gave originally in the general observations of the trial we knew the trial was a major success. Then upon the confirmation with top-line results we moved from ~3 to ~3.40 and likely higher next week I still haven't seen the B 2b results showing up in the news streams. The stock price has doubled to date on this one event and that is pretty good in my book. Of course I think the stock price was and is woefully undervalued still but I am not disappointed with the current run.
I think the company needs to follow up and get this company on to a senior exchange which appears to be in progress. We saw what trial results can do lets see what uplisting does..are the institutional in waiting..lets find out. Partnership, lets get this done! The other B is in the details but a one day antibiotic there has to be more than one big pharma looking at this. Both or either of these events can happen any time now. Aside the from B 2b results, I believe these are the next 2 big catalysts that could hit by the end of the year.
Aside from this we have B-OM starting up, Kevetrin at UofB, and the amazing 350mg/m^2 cohort at Harvard coming to a conclusion.
I have been staring at the stock price of this company since 0.19 cents then 0.50, 0.77, 1.00, had to eye surgery for the long 1.60's and now at 3.38. I do have to say, yes past performance does indicate future results.
Congrats all!
Do we partner before or after BoD? Leaning towards Leo and Dr. M to make the call on their own. Wouldn't hurt to have more voices during the decision process but not sure a newly minted BoD should have too much influence from the get-go.
WOW! Someone call the FDA we need to setup a meeting. Guessing it will take a day or two for news to spread oddly timed PR on a Thursday in the middle of trading.
Tedizolid was approved for complicated skin and skin-structure infections (cSSSI) not ABSSSI. But just for entertainment...It is also a spin off of Linezolid both are oxazolidinone class of drugs which has already been on the market for 14 years, good look with no resistance now. Tedizolid is a 7 day oral tablet which is good because I am not going to the doctor for 7 days because of a scratch on my knee. Lets say we are in a magical world where Tedizolid is approved for ABSSSI medically speaking compliance would work better with a one time IV of Brilacidin at the initial visit at the doctors office then sending someone home with pills to take for 7 days.
Jerry lets not confuse our 2a's with our 2b's there was no 3 day dosing in 2a only 7 day. So any reference to 3 day would have to be 2b. From the 2a the sustained response at day 28 for low, medium and high dose were 95.7, 89.6 and 95.6 respectively for Brilacidin with Dapto at 98%.
http://files.shareholder.com/downloads/ABEA-4ITCYZ/1997024712x0x611205/FEA66C67-D02F-4FF2-B230-AA711F46ED7F/PMX-30063_Antibiotic_Fact_Sheet_Nov_2012_.pdf
As far as the cell membrane I would invite to read publication from my colleagues at the University of Washington.
Congress is passing laws and the President is signing executive orders to desperately promoting antibiotic development. They must have missed your memo on heated up or the already crowded antibiotic market.
Jerry, Dalvance is another remake of a lipoglycopeptide antibiotic with cure rates in the 70th percentile, a second rate antibiotic that was on par with another 2nd rate antibiotic Vanomycin in human trials. Dalvance is a 8 day treatment, 1st day dose with an 7 day follow up dose not much help in patient compliance there.
Daptomycin is the competition and why we went head to head with it. With cure rates in the 90th percentile it controls 3/4 of the market with annual sales of 1 billion.
Brilacidin is a whole new class of antibiotics with synergistic affects in healing. Resistance is futile because it rips off the plasma membrane of the bacteria giving it no chance to adapt. Meaning it will get the full 15 years of market exclusivity provided under the GAIN ACT. Brilacidin sported cure rates in the 90th percentile in phase 2a so its on par with Dapto. In the current phase 2b trial we already know the trial is a success. Either back to back 3 day treatment or 1 day it beats 7 day Dapto for patients compliance. And if it is a 1 day treatment it will revolutionize the ABSSSI antibiotic market.
Now Jerry I am pretty sure your just not trying to "keep it real" because your smart enough to know the facts.
Tduggan, Scottrade also makes funds available immediately no clearance time. For me its a little dangerous ripping funds from a bank account and instantaneously sticking in to the brokerage account because its a little more work getting it out.
Some of Leo's great PR's have caused me to bounce the electrical bill =-)
(kidding)
The larger the sample size the greater the confidence interval. The data we care about would be exclusive to each arm but if referencing the pooled data Leo gave on the B 2b observations they are non-specific to any arm.
We go green from here. Swingers starting to reload biggest catalyst in company history incoming.
"data from all trial sites has been locked" means the data has been handed over for statistical analysis from what I understand. It shouldn't be too much longer now.
"Next few weeks time" Dr. Menon on B ABSSSI its around the 6 minute time on the youtube. One thing I didn't recall any of them mentioning was the possibility of a 1 day treatment or any detail there with the different arms. Good stuff all and all!
Thanks Sox, two weeks to 2b Brilacidin results!
Its been quite since RR
I hear you Karin, I don't have much faith in the CDC and the american medical establishment on the whole makes me nervous. Not only are we getting patients here now we continue to import them. I hope the government does know about Brilacidin and have that option.
Whoa Karin, the government stockpiling Brilacidin??? -I like it!
One trick pony a second tier antibiotic
Dalvance is two 30 minute infusions (IV) a week apart. I would think a 3-day would be preferred over relying on a patient to come back a week later. But what is really cool is that at least one of those one day treatment arms for brilacidin must have worked if not both, IMO. Dalvance is also not a top line antibiotic.
Brilacidin for ABSSSI should fetch a much higher price than Dalvance. Dalvance is a remake drug that went up against Vancomycin data from two of studies:
Trial 1: Dalvance: 83.3% and Vancomycin/Linezolid: 81.8%; Trial 2: Dalvance: 76.8% and Vancomycin/Linezolid: 78.3%.
Now recall the numbers from Brilacidin 2a efficacy no#s: 87%, 92.6% and 83.3% with the comparison being made to top of the line Daptomycin.
https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/1329/dalvance-dalbavancin
http://files.shareholder.com/downloads/ABEA-4ITCYZ/1997024712x0x611205/FEA66C67-D02F-4FF2-B230-AA711F46ED7F/PMX-30063_Antibiotic_Fact_Sheet_Nov_2012_.pdf
Citrati, yep hopefully the deal is only for B ABSSSI the rest of the polyheist drugs should be vetted further to establish their value let alone K and P. Of course, if the money is right lets say 10 billion for the whole kit and caboodle, I won't argue... much. =-)
The DRTX up 72% this deal assures at least a Brilacidin deal IMO or perhaps more. It would be hard to estimate a buyout price for CTIX with all those promising drugs.
Oh darn, Aruda Inc. is our first institutional owner http://investors.morningstar.com/ownership/shareholders-buying.html?t=CTIX
=-)
Monolith, I think we turn green tomorrow. The swingers need to load up for the possibility of a Monday PR. We got some good potential PR news coming such as the start of B-OM, uplisting update and heck if the company has been prodding Harvard any we might get news of when the next safety committee meeting is for Kevetrin.
But yeah with no PR I am guessing it may be 2 weeks or so before the buying frenzy begins in full for B-ABSSSI.
Is it just me or is Prurisol just a complete laggard in this bunch? Brilacidin and all of its indications seem to be blowing right by P.
Sweet Apparition, that needs to be Jimmy B's teleprompter. I got two people at work to actually open Scottrade accounts to invest here. They have never done anything like this before, invest that is, and I actually purchased there first shares for them as a tutorial. They got in at 1.60's and have been jumping up and down for the last 2 weeks with this move to 3. I keep telling them that is nothing this thing will be at 10 in about a month, but they are getting "itchy".
So did jimmy b mention CTIX on squak box?
Everyone get your Survivor "Eye of the Tiger" cds out. With all the catalyst upcoming this month we will not have to listen too long. Weeks away from the companies biggest announcement ever and we already know the answer! 1-day antibiotic incredible!
For those that don't have the cd please see along below: =-)
Rising up, back on the street
Did my time, took my chances
Went the distance now I'm back on my feet
Just a man and his will to survive
So many times it happens too fast
You trade your passion for glory
Don't lose your grip on the dreams of the past
You must fight just to keep them alive
It's the eye of the tiger, it's the thrill of the fight
Risin' up to the challenge of our rivals
And as the last known survivor stalks his prey in the night
And he's watchin' us all with the eye of the tiger
Face to face, out in the heat
Hangin' tough, stayin' hungry
They stack the odds, still we take to the street
For the kill with the skill to survive
It's the eye of the tiger, it's the thrill of the fight
Risin' up to the challenge of our rivals
And as the last known survivor stalks his prey in the night
And he's watchin' us all with the eye of the tiger
Risin' up, straight to the top
Had the guts, got the glory
Went the distance now I'm not gonna stop
Just a man and his will to survive
It's the eye of the tiger, it's the thrill of the fight
Risin' up to the challenge of our rivals
And as the last known survivor stalks his prey in the night
And he's watchin' us all with the eye of the tiger
The eye of the tiger
The eye of the tiger
The eye of the tiger
The eye of the tiger
The eye of the tiger
Read more: Survivor - Eye Of The Tiger Lyrics | MetroLyrics
Big blocks, tick-tock. RR was a hit for sure and these cats may not let you get your shares back!
Last time I saw price action like this was Amgen's 1.2 billion buyout of Micromet. From Dec. 2011 it went from ~$6.00 to just over $8 in one month then lunge up 30% to about the $11.00 buyout price upon announcement. I just got in just under 6 and it seemingly just kept going up from the moment I bought it. I had no idea of the buyout was coming but in retrospect for a month a lot of people did know. Nothing makes being an idiot more tolerable than money.
I don't believe this is happening here at all but it looks and feels the same.
Hahahaha...I don't know what to think if BK and NR start a sing-along here. I guess I will have to start reading georgees post just for any kind of contrast!
Gov. good point, these pharma that have 1 or 2 drugs phase 1 with 1-5 billion market caps may have given away too many rights to big pharma too early for short term gain. Leo's strategy of developing them first in the long-run should be best for shareholder equity. Powder-keg situation!
Still frustrating though. Clovis etc often have drugs for rare cancers no big revenue projections but a faster path to approval but Cellceutix have this as well with there big 3 and it takes a massive tornado of data releases and news catalysts to get us to a 300m market cap.
Hopefully a reckoning is at hand here now!
Here is the PR that mentioned Clovis Onc. from last year involving UofB trial design with AML.
http://cellceutix.com/cellceutix-updates-kevetrin-dosing-increases-and-prurisol-anti-psoriasis-drug-stability-tests-underway/#sthash.6u6SQ9TI.dpbs
CMC great post! Clovis Oncology Inc. is a company that Cellceutix has mentioned before and another head scratcher. The cred. will come when the company is vetted by big pharma in a partnership...big pharma will leave no stone unturned. Cred. will also come with uplisting with all of its oversight rules. People don't talk about it much but our company has a cred. problem (its the only thing that can explain the pps) that will soon be resolved. IMO
Dr.Reddy's seems to only get involved when there is some type of reformulation work done such as Prurisol oral tablet and B-Ocular (liquid B). Interestingly from the wording of the PR the company itself may have been the ones to stabilize B at room temperature. The base material for Kevetrin and Brilacidin are "common" in the pharmaceutical world and are readily synthesized in the lab. No need to build a manufacturing plant while the drugs are still in trials.
Lets see what we got here if all goes well:
Brilacidin: 1 day treatment for ABSSSI. Has their ever been a 1 day antibiotic treatment for any microorganism before? Truly amazing! B's success here doubles the chances for B-OM, B-Otic, B-Ocular, B-Diabetic foot. Novel, unlikely to develop resistance, highly incentivized government programs. Partnered with big pharma by the end of the year or perhaps the government will buy it out under executive order.
Kevetrin: with the activation of p53 we may well usher in what could be the new backbone of cancer treatment. It may take a decade or so to explore its full effectiveness in all solid tumors and blood cancers. Endless partnerships and money in this one. Truly a platform drug here.
Prurisol: An oral tablet for moderate to severe psoriasis patients will gobble this one up.
Then we got antifungal, gram negative and the rest of the defensin-mimetics platform. A treatment for COPD-Huge! Caveman guess here were sitting on 50 billion+ of drugs? Someone has got to buy this out before much of this comes to fruition?
EAT YOUR BROCCOLI! =-)
I remember the struggles of getting the pps over $1.00 seemed to take forever but now I believe we will blast through $3.00 perhaps 4 and 5 too.
Expecting followup PR on uplisting progress, unblinding of B 2b and the start of B-OM all in the next week or so.
Good times!
TD, might have to demote you to Demigod!
I have a p53 story from work. We had a professor come over from Harvard last year, she was part Brigham and Women's Hospital, Harvard Medical School, and Mass. General. Her work is in myogenic cancers those derived in the muscles. She has fish called p53- where they knock out p53 and then plant cancer tumor constructs in to the fish. Well she had a undergrad running one of the experiments where the constructs "leaked" and within days the fish had a tumor nearly the mass of its own body (these were in larval fish). The aggressive growth of course was in p53- fish.
I told her about Kevetrin she had never heard of it. When I said it was non-genotoxic she said "I didn't think that was possible" Conversely, when I asked her about Nutlins she said "that is very toxic". I got a little tongue-tied when explaining Kevetrin's approach to MDM2 pathway so I showed her the companies website. She seemed very interesting.
The important thing here is: If Leo announces a study of Kevetrin with Myogenic cancers at a major cancer research University....THAT IS ALL ME BABY!
EAT YOUR BROCCOLI!
Hey TD, perhaps more interesting will be the change in tumor size, decrease serum tumor marker since these are more measurable/easier to understand than p21 in fact one might want to correlate p21 to the other two secondary measures. I assumed the secondary data is only completed up to cohort 4 just assuming one starts at cohort 1 (or 0) and the data for p21 is only for 14 patients at very low doses. So it sounds to me that most of the data so far is to complete the primary objective safety and dose escalate. Blood samples are being stored for p21 testing later and perhaps serum marker which was mentioned with ovarian cancer. Just a thought..
I am an aquatic biologist/engineer I run experiments all the time (nothing at all like what CTIX is working with). But during an experiment I am not focused at all on analyzing data but rather on making sure everything goes as planned to complete the experiment. I finished a year long experiment 2 weeks ago now I have 1200 images and ~2000 frozen samples to go through. I wont know much about what happened during the experiment until I start to process those samples starting from the beginning and processing data in batches. Science is busy work I didn't really look at the images I took at the time other than making sure I took the picture correctly and saved it to file. The samples went straight in to the freezer.
Just say'in that just because K p1 is now 2 years old and we are not all rich because Leo filed for breakthrough for curing cancer or there was great information leaked out about the trial rather no one really know yet. They have not really started to analyze the data and are still on the primary objective- the experiment. Images and samples for the most part are stored away for later analysis they are not critical at this point.