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Correct. That's what makes it easier to globally register. And that will expedite and streamline the costs for ONCS once they garner device approval.
The interesting aspect f this whole ordeal is: In the US it's a drug and Canada and Colombia (LOL!) as well, but for the remainder of the World including the EU for a CE mark it's a medical device. As a matter of fact the entire World will use the EU CE mark as a determinant for admission by the governing body. They lean on the EU and the US; however, Japan uses the physician exception to an extreme and that makes it easier these days for data. Same used to be said for Germany and Switzerland but the new harmonized EU standards are putting a damper on that now and NEMKO is leading the way so they can monopolize the audit process. Neopulse is already in the books in the EU, they have a hold on it. Why they chose to go US for Immunopulse is because a majority of the journals are in the US and will be very useful as a marketing tool. Add to that the US is also the quasi rubber stamp that the EU is; and now that the EU has NEMKO lobbying it to be more stricter like the US then might as well garner approval here first. No, this kid is sharp and the patent Councel is sharp as well and the new Reg officer was a friend of mine from Biogen. It's a small World.
I know what's going on. I have all the timelines drawn out...the cliff is near for many shorts, some MM's may get notice and pull out first, but it is near. I'm not telling.
LOOK, I don't Blame You for Profit Taking: The Trouble Is I Read the Industry Graphs Over the Last Three Months and Tied it Into Shifting Bank and Holding Corp Funds and Can See Energy Money is Pouring In small cap bios. I Think IDRA is in the perfect storm situation as well. Everything is coming together. Most of their 2004 technology acquisitions are being funded now and they have re-orged, grown and made some top tier talent improvements. I can see the Baker Brothers and Abigail Johnson from Fidelity maxing out their SEC buys, and why not? They have first dibs on IDRA and are rooted right next door on the Boston Wharf so they can stroll in for lunch or tea any day. Nope, this keeps climbing and my thoughts are flipping may be fine and dandy but you better be damn good at it because the spikes are going to become increasingly violent more on the upwind Heiken Ashi Candles GREEN than Red. Too easy to see you will change your habits and go long and hold for sustainable 300-500% old school runs instead of this ticky tack let me cash in on 50-80% schtick.
SCRATCHING MY HEAD ABOUT THE PPS, no really.... How does a company with record sales go down in PPS v. up? Especially with ebola stocks going jihad lately...
I mean what gives?
It's a Pandemic now... =(
MASSIVE ORDERS COMING IN!!!! http://www.zerohedge.com/news/2014-10-15/dallas-commissioners-will-declare-state-disaster-tomorrow-over-ebola-fears
HEADING OVER $2.00! WATCH AND LEARN!!! CDC APPROVED MEANS $$$$$
LOOKS LIKE THE TRAP IS RUSTY... ROFLMAO!@!
WHO SOLD????? LOL!!!!! $THEY ARE ALL ABOUT TO BLAST OFF EVEN HIGHER
THIS WAS THE LAST HURAH UNDER $5.00 FIVE DOLLARS..... Soon we will be hearing settlement talk as the 2016 Caucus looms near and the Republican nominee looks strong for the running. I believe Hedgies will use this political change as an opportunity to leverage the political diaspora into signing off on an FHFA release. PAC money will pour in and make life very difficult for the current caucus as the likelyhood increases day by day.
CNN and WALLSTREET SYNDICATE ATTACKING THE FEDS FROM ALL ANGLES NOW.....No money ever realized back to the taxpayers from F&F. Feds hording it. Taxes going up... All the tax paying investors got screwed too, Feds will not let go. Something has to give....and Oh it will.
Better believe it.
-M-
ANYONE HERE WILLING TO SHORT A MOMO STOCK WITH TONS OF SUDDEN ATTENTION???? I don't think so...
NOTHING WILL CHANGE, F&F is going through the routine again,,,see 1982,,,they were cut loose. Same process, different time.
FILLED THE GAP. ALL UP FROM HERE!!!
COURTS CAN NOT THROW out a con law issue....THIS IS JUST PLANE DUMB
SHORTS NEED TO COVER, today... Word on Wallstreet is serious pumplogy101 for F&F next week. Going to be bear trap paolooza like shooting em in a cage.
FNMA and FMCC Short Squeeze, the discovery process will reveal collusion. The banks tried to get away with it and now are paying the price by being forced to buy back the lame mtg’s. They made enough money during the whole snafu by cutting a deal with the Feds to all but eliminate interest rates. Now F&F has to pay the price by reformation for a blatant wrongdoing by the banks. Here the banks never had a percentile interest paid back to the Feds., instead it was interest free. Both are FDIC backed., no discrepancy in the Statute, Insurance is Insurance. We have a problem Houston!!! You just don’t make discrepancies in statutory compensation dispositions and repayments. The rational was not delineated well enough and it was a contract clause of adhesion for the Feds to take ALL! Some serious collusion going on there. In the discovery process when the Attorneys point out the Dems involved the crap will hit the fan. Especially if there is a nexus to reformation and how they stand to make gains outside of their office duties by Trust investments. This could get ugly. Or it can go away with a new release plan. Guess what happens? Nothing.
F&F keeps on trucking. Watch the way DC deals with it. Same crap different era.
Dead Cat Bounce: Meaowwwwwwwwwwwwwww (thud)!
Let me know how good Monday is when it rises in the morning and then sells off, if you're a flipper you will be ticked off..I'll ride it out but no way in Hell I believe it's going higher without dips and this is perfect for one, textbook. Hope I am wrong. That is all.
I agree, but all these unrealistic pumpers are the ones who usually sell off first.
Sell Off Monday, Can You Read It? MM's seemed to be playing games Friday with a rush of big block buys and tons of pumping on the news...tomorrow night if no follow up, serious manip for sure Monday and stops palooza taken out.
He ate at Shoney's and was feeling sick! How many spoons did he touch at the self serve booth or bathroom handles???? How about his wife and kids??? and the schools and their jobs and coworkers and on and on and on...
I'll be in Puerto Rico in December, both are scaring the Hell out of me...
Hedgies Betting: Tweeting all over the the Internet $40.00+
BOTTOM__LINE: TKMR is the leader for ebola and will likely remain for some time.
Tekmira can get 200 doses to the WHO with no problem. As far as 1 million doses? Not happening...
Sorry, I am a realist. I can see maybe 200,000 to 400,000 max. I just don't see the output capability until spring and by then ebola will be around 4-6 million people. I believe by then the US and other countries will have shut all transport down to Africa, in and out. Anything crossing into the Middle-east will be short lived since they are more educated there and more redumentary brutal in their quick massacres of people thought to contract the disease. It will be a witch hunt and finally allowing the cycle to pass. They all do. Question is will this one go one year as stated by the sp called experts? Well, I am going to contact my old prof at the Harvard School of Public Health and let you know the real facts. I want to know more.
I realize there is also other problems right now with rampant viral diseases. I am supposed to travel to Puerto Rico this fall and right now El Dengue and Chikungunya is rampant...epidemic like the islands in the Caribbean have not seen in a long time. Both are a horrible way to go as well.
All in all, I see TKMR leading the way for now. I am hopeful though the Russian's have a nice elixir as they have stated to add to the fight.
First of all, good subject header...it's the truth.
"Tekmira is ahead of the competition in the race to find a cure for ebola."
Now to answer with my opinion on the so called "others" briefly without too much info:
Competitors listed in alphabetical order
BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) is located in North Carolina with an additional location in Alabama. They use a process called structure-guided drug design to identify and determine molecular structure of the protein in order to design a drug for optimal interaction with the protein. They just received funding to advance development of BCX4430 for treatment of hemorrhagic virus diseases. They are currently in pre clinicals with BCX4430. This funding will allow moving forward with important primate studies, filing of an IND and Phase I clinical trials.
Response: Not happening, they lack the research infrastructure at Triangle Park to develop a vaccine quick enough, most of their products are derived from papers scoured at Penn, Harvard and John Hopkins. Their clinical program is also not as efficient as I would like to see.
Also their phase gates reviews are always delayed.
STRIKE 1! They are out.
Chimerix Inc. (NASDAQ:CMRX) is located in Durham, NC, and is focused on developing oral antivirals in areas of high unmet need. They've put out a press release 9.3.2014 updating their Ebola work. There are no test results from animals yet. All work thus far is in test tubes. They are also one of the companies attending the WHO conference in Geneva.
Reponse: This a joke? No really. No test results? Is the design sketch ink still dryin on the evaporator hoods? Strike 2 !
Fujifilm Holdings Corp. (OTCPK:FUJIY) U.S. partner MediVector Inc. in Boston is privately held and in contact with the FDA regarding their anti-viral compound Favipiravir for usage against ebola. Most of their funding is for their work against the flu. They've started enrolling patients in a Phase 3 clinical trial for Favipiravir against the flu.
Response: The molecule is similar to what TKMR has already, except TKMR has a more efficient delivery mechanism utilizing nano. Nothing new here folks, move on.
Strike 3!! OUT!!! Next batters….
GlaxoSmithKline plc (NYSE:GSK) GSK has a significant global presence in over 150 countries. They are working with research partners to develop a vaccine to prevent ebola. GSK acquired the product when they purchased Okairos in May 2013. Discussions with regulators are ongoing to advance to a Phase I clinical trial later this year.
Response: Glaxo is a five hundred pound gorilla, like Biogen Idec a company which I worked for it will take an act of Congress to get protein formulations and the red tape Arena into some sort of mouse model study...many months if not years folks.
Strike 1 !
Immunovaccine, Inc. (TSX.V:IMV) (OTC:IMMVF) is in Halifax, Nova Scotia. They have recently been testing a vaccine for the prevention of ebola on exposure. The two primates that were vaccinated and then exposed to ebola 70 days later lived. Hopefully, this eventually works as a preventive in humans too.
Response: Here we go again, mom and pops soup kitchen. Even of they formulated the fountain of youth we are back to stage one again, infrastructure…. Mass production capabilities. You just don’t throw recipes over the fence. It doesn’t work that way.
Strike 2!!!
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) executive offices are in Plymouth Meeting PA. They published pre clinical data on their DNA vaccine preventing Ebola and Marburg filoviruses in May 2013. Press release can be found here.The published abstract from the trial can be found here.
Response: In the words of Adam Feuerstein, “We have entered into the realm of maximum bullshit”
Strike 3! Next batter
Mapp Biopharmaceutical produces ZMapp, and they are located in San Diego CA. The company is privately held and can't be traded. Their antibody treatment is produced in tobacco plants. Licenses are transferred to Mapp's commercialization partner, LeafBio. The treatment was only effective in 43% of the animals when they did the pre clinicals.
ZMapp has been used in six human patients thus far. Two US missionaries, one Spanish priest and three other doses. The two missionaries are alive, but the priest died. Of the three doses sent to Africa, one Liberian doctor that received a dose has died. The status of the other two is unknown as I write this. We can't tell from this small number of patients whether or not these antibodies work. 55% have died from the current outbreak and those with supportive care have usually done the best. The two that lived most likely have better immune systems than those living in the outbreak sites in Africa. Better immune systems coupled with better supportive care make a difference in itself. Again, we don't have enough data to know whether or not this drug actually made a difference. I hope it did since we need an effective treatment, but, we simply don't know yet. The recent deaths of ebola patients using ZMapp may dampen the demand for it in the near future.
Response: Well, we know some things now. One they can’t make enough of it. Two, they can’t make it fast enough. Three, it didn’t work for everyone. And Four, there was even one whom had a bad reaction.
Strike 1!!!
NewLink Genetics Corporation (NASDAQ:NLNK) is based in Iowa, USA. The company is cancer focused, but, expanding its pipeline to address Ebola viruses via its subsidiary BioProtection Systems Corporation. The letter contract they have with the US Defense Threat Reduction Agency (DTRA) is for studies that will bring an ebola vaccine closer to human clinical trials. Their product has been developed by the Canadian government.
Response: Newlink genetics was supposed to be ready for a 100 patient cohort quasi rushed study back in mid August. What the Hell happened? This one just fell like right off the cliff.
Strike 2!!
Peregrine Pharmaceuticals, Inc. (NASDAQ:PPHM) is in Tustin CA. The company is developing antibodies for the treatment and diagnosis of cancer. They did some research in 2010 dealing with Ebola, but, it doesn't appear to be a focus of theirs now. The most recent press release that mentions ebola is from November 17, 2010
Response: This one is hilarious! They have a reputation now for mixing up controls; just ask the FDA and the shareholders. ROFLMAO! Yeah, their Clinical QC is with it and sunk for cash.
Strike 3…OMG We have already struck 3 batters in 3 innings and going for a no hitter!
Profectus Biosciences is a privately held company with locations in Baltimore
more MD and Tarrytown NY. They are working on vaccines to protect against exposure. According to this press release, they look forward to combining their vaccines with both Tekmira's therapeutics and the Vanderbilt antibodies.
Response; Too much BS here. Go back to the bench. Heck I can dig up five online papers right now.
Siga Technologies Inc. (NASDAQ:SIGA) is in New York NY. They develop vaccines and therapeutics. Ebola is one of their discovery targets.
A recent court ruling requiring them to pay lump sum damages to PharmAthene PIP may change some of their priorities. They intend to appeal.
Response: Oh great, a Galena wanna-be tied up in a legal money drain; nice company. They should be ready in a few weeks to help
Sarepta Therapeutics (NASDAQ:SRPT), formerly AVI BioPharma is in Cambridge MA. They use RNA technologies to find new therapies. They completed Phase I safety studies in 2012 in both the ebola and marburgviruses. Study results aren't released for either one on the Clinicaltrials.gov site. The ebola trial scheduled to start next was withdrawn due to funding constraints.
Response: Oh well...As a prior senior protein formulations scientist with a lot of viral experience, "if it isn’t published yet it more likely than not means it’s bad news".
Look I have a good idea of what’s going on. It's TKMR or nothing right now. Forget about the stock, at the rate the virus is spreading, 1.4 billion estimated by mid january if the Russians don’t help out we may see something that has not been witnessed in a long time. I think the endemic spread margins are also being down played. It’s worse than they are telling the World because if it wasn't then why are the South African already setting up check-points? Eh? Something smells really bad, and it's probably fish.
ROFLMAO, there are no other companies. Only TMKR. They want the World to think the scientists are all hot on the ebola tail, the truth is it takes a long time to go from lab to patient as in years. Mapp has already shown it can have a serious allergic side effect, and that's about it folks! Nothing to deliver to Africa right now. So what to produce? Who will produce it? Who has the process design for high output? Who has the infrastructure supply management chain? Who has the experience with animal models and now quasi clinical field use? Who has the quickest patent recovery results?
TKMR. No argument, this is as slam dunk as it gets. We should be talking about military containment and medical treatment sites at this point and who bears the cost because I can guarantee its already a done deal. The new hedge fund moves were the tip off, they always have the IN.
Fur, normally I would say it's a scam for an OTC but not this one. I know why they went OTC to begin with and not NYSE or NASDAQ, most of it has to do with the tax structure of the corporation. It suited them then but no longer...with the recent influx of talent and corp profile they will uplist to a larger exchange to acquire easier funding to broaden the pipeline. And reality is until the company is selling a product with a stream of revenue, stock dilutions will come. It is not a bad thing for a good biotech corp. ONCS is a good biotech corp., this is not a golden parachute program for profs to retire after teaching. I can tell you right here and now Punit and his dads intent is to build up the company and sell it, period. No doubt in my mind that is his intent. He's following the recipe to a "T".
Nevertheless, the frustration level will grow even more severely as the market keeps taking hits through October and hopefully by the grace of above we will see some nice PPS movement.
Another factor which has hurt many small biotechs is the fact that large monopoly biotechs have been getting fast track and approval left and right. This tends to harm not benefit smaller biotechs PPS's. A lot of money is pulled out and or distrust in the competitive edge hence shorts mentioning Merck or Baxter or Pfizer etc., but what they don't realize is that these big pharma corps do not want to cure people, they want to to treat them as many times as they may to make a lot of money. How do I know? We used to reduce concentrations of many small molecule products and add tons of excipients to broaden the profit margin. Ethically, wrong. Business-wise it was cut in the cocaine (B-12) so to speak and that is how one makes money. I found it wrong but the Program Managers were given marching orders. I know for a fact that some drugs molecules we made were so strong one cycle could easily wipe out a stage II, but no, that was bad for sales. Nope, they said to lighten the dosage up and usually made us do it by questioning our design risk analysis, that was the message. You went against it you got shown the door.
In this matter, I really believe this company wants a niche and in order to achieve it it must show above and beyond therapeutic efficiency. I believe they have and will continue and you have to remember like the oil industry there are a lot of big names that are purposely antagonizing new technology and denouncing it even if its better because its bad for their strong hold. There are a lot of medicines out there being held back from the market because of the mafia lobbyist from the insurance companies and large biotechs. take Cesium 133 for example, great stuff, excellent resource for various therapies but you have the big gorillas throwing a bone to the EPA never mind the FDA or colloidial silver which i have seen under a microscope absolutely demolish Hep B or Rhino or Strep., and on and on and on...
No, this small company has to become a threat and in order to do it it must ride INO as the bull and allow the public to digest new treatment options. Eventually as the success stories and data pile up, some company will finally nab ONCS and say: "we were wrong all along, this stuff is great!" The question will be who is following ONCS the closest? That is the company to watch. If they partner with ONCS they may eventually outright buy them if the product is a success.
ADAM FEURSTEIN thinks Tekmira is the cheese...he keeps tweeting them:
"Ebola patient Dr. Rick Sacra was treated w/ $TKMR TKM-Ebola for 7 days, confirms Nebraska Medical Center, in a statement."
Actually, I didn't you did. I found out through a Linked-In connection for my history dig, and as far as Yahoo, iHub and the rest of the info jungle all I read was about the in house councel hire (very nice) and Pierce's wife (which is no bid deal to me---IMO).
I tried to tell you that.
Interesting,
Helen Mayfield, the new RAC Manager at ONCOSEC.
We worked for the same company at one time. I knew her from my dept in Pharmaceutical Science. I was a Senior Protein formulations scientist (yes, immunotherapy stuff) and she was process V&V for virology. I was fascinated with her work since she focused on processes I was unfamiliar with. Her process validation on designing V&V’s with qual check points for transmission of possible diseases from Korean Hamsters which were utilized for bacteria phage vector RNA trascriptance was a site to behold. The flow charts posted in the req room were dizzying to follow but made accurate sense. Imagine fermenters 20 feet high and 100 feet long. Viruses and other contaminations can get into the mix so she was involved if I remember right in some pretty cool ISO-Assay and PCR SOP’s as well. Anyway, I didn’t even know she transitioned over to reg’s. She is one sharp cookie though, a top notch talent. Biogen does not employ duds, she was in building 3 and I was in 4. And she was there for the Amevive FDA approval in 2002 which was the coolest show to ever see. It was televised in our auditorium with free beer and Jamaican jerk pork and on and on…for goodies. Still can’t believe she’s in regs now let alone Oncosec. Anyway, that proves to me it's a small World, i'm out of touch more than I thought even with the Internet, they are close to something sweet and very confident about it and they are going out and acquiring some excellent talent to get this thing done. She is my verification of my positive speculation. You go do your own.
Not only that but most don't realize the virus has a 100% chance of mutating in a population of 100,000 or more for a duration of 6 months+. By then TKMR will be making a minor change in RNAi code and the others will be still having their facilities validated. Tough to do both in a pinch and very expensive, TKMR is way ahead. People will realize this soon enough...and I'm not pumping, I'm a realist.
They are not near term competition. Not even one of them has high mod production capabilities cert., by the FDA. The FDA has to walk and in and verify even for emergency use pilots. And they are not going to circumvent the FDA to go OSU because that means the corp would be wasting money since they would have to do it from scratch again to cert in the US.
TKMR is ahead in this regard.
I don't need your DD or your sarcastic remarks. OK? I told you what it takes to move a corporation, I have been around a long time and have gone through a few startups to IPO's including two that are traded on NASDAQ Sepracor (now Sunovion); Biogen (now Biogen Idec) and a couple of others.
1. Phase I Melanoma study long term survival data
Phase 1 is inconsequential. Animal models and biostats, Toxicon on the east coast is Intertek on the West Coast; for layman this is hogwash stats, talk Phase III and everyone pulls out the scotch, see MACK for results of MM-398. And long term. What is that anyway? What quantitative measurements do they have to propose it is long? What are they comparing it to? Did they ever divulge this criteria? I never read it. it doesn't mean that they don't have it, but MACK stated their endpoint goals. What are Immunopulses? Please enlighten me, after all I don't know a Phase IIa from a Phase IIb.
2. Phase II Merkel Cell Study Data
Wonderful, big deal. Tell me about the aggressive indications from a cellular taxonomy standpoint. I need to know what aggressive cells mutations they are talking about. Want to know how to prevent Merkel Cell Carcinomas? Shave your body hair, the Egyptians knew about this 3000 years ago. Think I am talking BS? Go read New England Journal of Medicine and don't ask me for the Journal date, I don't have time to educate a bunch of mortgage closers...
3. Melanoma Combination Study Strategy
Oh yeah, I read about that some time ago. Maybe it was on this blog. Anywa, where did they get the scientific papers to justify investigating the combi? Is it published in some peer reviews? Did they point them out? I don't know, maybe I just missed them. If you know, post the link. Oh and do tell me what the combi is, I don't recall the compounds or immuno's combi they are referring too.
4. Initiation of new Phase I/II Clinical Study in non-skin cancer indication
OK, what does this mean? I don't remember this at all. Do you even know what a non-skin indication is? And if so why bother studying it for product applications when no oncogenetic mutations have even transcribed some sinister RNA's yet? Come on!!! Give me a break! Fruitfly science.
5. Final Data of Phase II Melanoma Clinical Study
OK, this one has meat, but alas and to reiterate some bell curve sentiment what do I know? After all I think a Phase II just goes to a Phase III without a b or an a. Do me a favor and enlighten me. Actually, I have some questions for you: Will Immunopulse be registered in the EU as a drug application or medical device and why? Is the EU about to change their registration policy and will it make it more expensive? When is this proposed? Is it the same for China or Taiwan or South Korea? How about Brazil? Oh yeah Neopulse, they never notified their body for the EU, I was talking BS. Right.
And why did the FDA make Oncosec go through the NDA process and not the PMA? is not IL-12 already approved as a drug? Why are syringes considered a medical device yet they are as in vitro as immunopulse? Why is an MRI a medical device but delivers 10,000,000 the amount of energy than a standard 16v electroporation electrode array? You know I can go on and on and on....but my point is this: are in the dark and guessing? Maybe.
I have my window into some stuff they are doing but not all, I have my reasons for the way I think and you all have yours. But don't give me this DD events is a justified reason for PPS movement. The market determines that. And many are not educated enough in the market to even understand what the heck they are reading. See RXii and the cohort baseline pic stanfu as demoed from CEO Dr. Get himself for an example of what not to show for an RNAi efficiency study.
There are a lot of plumbers and bankers out there who know jack about this technology and many are just riding the wave and don't see the light at the end of the tunnel, they just see day to day flipping, scare tactics by bashers, so called BSing from posters like me, and on and on...but don't be disappointed and posting time is of the essence stuff out or other jargon because it may take longer and few more R/S's are announced (worst case scenario). The money has to come from somewhere and the p-ship may be done and the CEO may be absolved from questioning concerning his ethical loyalty to the commons, but please realize sheet happens and sometimes it takes a bit longer than you expect.
I've seen too many good companies get pummeled lately and it really bothers me, especially the ones whom I have personally worked at or visited or am Linked In with. This is a good company, have patience and I apologize for my rant -- I needed to talk.
LOL! Inovio? They can't even get their first product out of the gate and what are they going to do? Electroporate RNAi into the bloodstream? Nah...
And the other corp is a shell farse.
Fur,
I don't agree with you, I believe it could be longer than you both think or realize. They just hired a councelor, and I realize her forte' is IP but I'll bet they are using her for contracts as well. And you just don't sign p-ships in 6-8 weeks. It takes that long just to negotiate terms and conditions and get the SEC filings in order. And no, I agree, December is not good because Santa and Midnight Moet is in order.
As far as crunch time, they have until spring in my opinion before nerves set in. Swell if anything transpires prior. But I would not wager on anything sooner than November.
I read it, and it read to me like you're impatient. And in my book impatient people are usually negative. You read?
BioCRUST, yuck: still not out of the starting gate.
Mapp, nerd outfit with no dirty hands experience to make the stuff on a mass scale.
TKMR is the only one with design and production realization.
Yes, when it comes to metrics you are the man...