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Half price..by paying 2.80 premium ?
Your are welcome. My position is a long one (couple of years) but I do expect to see incremental move in PPS. From science perspective, the odds are high that any news flow will be positive than a negative unlike a P1/II drug failing in P3. Only -ve aspect I see is the 'incubation' (no pun intended) period for time-to-market is long. Not all investors have that type of horizon.
Hopefully partnership talks that Dr Kim alluded yesterday will materialize in next few months and help to set a new base for INO stock.
$CLDX This is bullish .
In today's Q&A session, Dr Kim categorically mentioned that Inovio's vaccine are the only synthetic ones being tested today. This repudiates the SA article published that mentions that Novartis also makes synthetic. Dr. Kim went further to explain that Novartis's vaccines are adjuvant (Wiki: meaning it is a pharmacological or immunological agent that modifies the effect of other agents, such as a drug or vaccine).
I tend to lean towards Dr Kim's claim as how else can you explain Inovio's patent portfolio especially the Synthetic universal vaccine against the dreaded H1N1 virus.
Interesting
You are right on the money. Dr.Kim is top notch and was awesome today taking pains to explain and answer every question. His choice of words such as 'tip of iceberg', transformative etc makes you wonder where INO will be by end of 2013. I see atleast low $5's.
Added more at 5.15 today..gift from market Will trend up into results due end of March. Odds of +ve outcome high.
Lol..did u try either seeing the presentation deck or participate on the webcast ?
Best so far from Dr. Kim and more to come. Here are some key points:
1. Partnership talks are in progress. Expect news in nex few months
2. Inovio's vaccine are the only synthetic vaccines currently being developed. Novartis is not true synthetic; more like adjuvant
3. Strong patent portfolio
4. News so far is just a tip of an iceberg - to quote Dr. Kim
5. 2013 year is going to be "transformative" / "epic year" per Dr. Kim
I have added more today and in scheme of big things to come, folks who sell out at these prices will wake up to find a partnership or successfull trial news from Crontech (due this Quarter - confirmed today) and see pps gap significantly up.
All IMHO
Agree . I am more interested on getting the AA for CDX-011 for any of the indications. EMERGE seems to be the likely candidate (subset) which should bode well for extensions (other trials including the one you referred).
It could be a close call. What do you think ? TIA
Accelerated Approval path. Seeing the example written in the FDA link below (quoted), it seems almost it's meant for CLDX scenario (Emerge)..wow
http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm
The FDA bases its decision on whether to accept the proposed surrogate endpoint on the scientific support for that endpoint. The studies that demonstrate the effect of the drug on the surrogate endpoint must be “adequate and well controlled” studies, the only basis under law, for a finding that a drug is effective.
Use of a surrogate can save valuable time in the drug approval process. For example, instead of having to wait to learn if a drug actually can extend the survival of cancer patients, the FDA might now approve a drug based on evidence that the drug shrinks tumors because tumor shrinkage is considered reasonably likely to predict a real clinical benefit. In this example, an approval based upon tumor shrinkage can occur far sooner than waiting to learn whether patients actually lived longer. The drug company will still need to conduct studies to confirm that tumor shrinkage actually does predict that patients will live longer. These studies are known as phase 4 confirmatory trials.
If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug. If the confirmatory trial does not show that the drug provides clinical benefit for patients, FDA has regulatory procedures in place that could lead to removing the drug from the market.
Here is the link:
http://boardvote.com/symbol/CLDX/communique/205900
CDX-011 Developments
In December 2012, we had our end of Phase 2b meeting with the United States Federal Drug Administration, or FDA, for our CDX-011 program, which we have characterized as positive. Based on this meeting, we intend to initiate a CDX-011 study suitable for accelerated approval in the second half of 2013. We are currently finalizing the clinical trial design and will update investors on our plans for the accelerated approval trial on our year-end 2012 call in early March 2013. Also in December 2012, we announced final results, as shown below, from the EMERGE study which suggested that CDX-011 induces significant response rates compared to currently available therapies in patient subsets with advanced, refractory breast cancers with high glycoprotein NMB, referred to as GPNMB, expression (expression in greater than 25% of tumor cells) and in patients with triple negative breast cancer. The overall survival and progression free survival of patients treated with CDX-011 was also observed to be greatest in patients with triple
The strong positive reaction to the stock offering where CLDX upped to $95 from original $75m offering indicates marketis waking up to the fact that CLDX going ahead with Ph3 via AA - likely means single arm study w/ GPNMB marker.
We should know more about the AA trial plans & timeline etc during planned year end call in early March 2013. The pps will be in low-teens by then, IMHO
While nothing is guarranteed, TSRX will be one of the stocks that will end up in double digits come end of this year. I hope to look back at this post while I am cashing my chips at the bank.
Yep..I like the odds too.
Karin,
CLDX is on AA track granted by FDA. The timeline you have posted is without factoring the AA path.
This major change is one of the reason they were over subscribed (90m instead of 75m worth of stock) and were able to sell at a pretty good price 7.50.
See SGEN trejectory...CLDX will follow..
I am into value stocks with 1 year potential that borderlines on awesome returns
INO IMUC CLDX TSRX to name a few..risk is distributed as well. I might get back into CTIX depending on quality / information presented in ASCO.
The interim look is for safety and tolerability. But some of the news from this likely to signal how strong or good the trial is going. See some of the previous posts that articulates this expectation.
As far as cash is concerned. they raised not too long ago in low 2's. I think they have enough to go until end of this year when the full results are expected to be released. Unless the stock moves quickly, my opinion is not any time soon.
I would suggest longs do not put any stoplosses. If you believe in science, the fundementals are all there and points to bright future for the company.
I see $500m market cap in couple of months which puts INO pps around $4+ per share. Lot of catalysts in 2013.
Excellent write-up in prestigious MIT journal. Talks about INO's unique DNA based platform. A must read:
http://www.technologyreview.com/news/510316/why-the-flu-is-so-relentless-and-how-technology-might-help/
Well, the interim checkup is primarily a safety evaluation, but should the immunotherapy demonstrate tolerability, I expect a positive reaction to the pps propelling to previous highs in 4's minimum.
It will be real interest to see IMUC doing an oral presentation in ASCO which typically tends to draw more crowd to such a session.
I see IMUC in $25 to $30 range early 2014 upon +ve results due this year but one step at a time
It all depends on the interim review due this qtr. IMUC being one of the best immunothereapeutic company (at par with CLDX), I expect quick ramp up to $5 short term. I am also hoping they will do an oral presentation at ASCO 2013 but probably not as full details of the ongoing trial will not be out until end of this year.
Regardless I agree, 2013/14 is going to be great for IMUC. Remainds of INFI..$4 stock early 2012 now is at $35 !
LTG, I really hope I am wrong for the sake of those patients. Unfortunately HEAT was a dismal news for HCC patients. Just don't want someone to get burned again. But I guess folks on $heff's board are pro's and traders..good luck to them.
IMHO, there is no future for CLSN. They are selling ATM to just fund the payroll. Likely this will go BK.
Guys, I have been an IMUC investor for quite some time.
For those who are relatively new, there was a wonderful coverage right on CNN about ICT-107 and how it's remarkably enabling couple of patients still live. Actually none other than Dr. Sanjay Gupta interviewed that GBH patient who against all odds still is alive.
We haven't seen anything yet on the IMUC's enormous potential. If DNDN with its 1st generation technology is north of $6, IMUC deserves much more with their next generation breakthru that is not only less costly but can be delivered to the patient quicker.
$NAVB to collaborate with Maimonides Medical Center on cinical trial utilizing Lymphoseek for lymphatic mapping in colorectal cancer.
Sorry for the typo in my previous msg. The ticker for Trius Therapeutics is $TSRX
$THRX
Piper Jaffray
C O M P A N Y N O T E
D e c e m b e r 1 3 , 2 0 1 2
Trius Therapeutics, Inc. (TSRX) Overweight
Top Pick for 2013 Ahead of Pivotal ESTABLISH-2 Data in 1H:13
PRICE: US$4.58
TARGET: US$13.00
Changes Previous Current
Rating — Overweight
Price Tgt — US$13.00
C O N C L U S I O N
2012 has been a memorable year for biotech. Recently though investors have become
more defensive, locking in gains and taking year-end profits. We look to hit the "reset"
button on January 1st. Despite macro issues such as the fiscal cliff taking center stage,
we expect the robust productivity of the biotech sector to result in new drug approvals
and launches, driving profitability and continued M&A. Trius is one of our Top Picks
for 2013. The primary value driver for Trius remains data from the ESTABLISH-2 trial
by early 2Q:13. Trius remains on track to file an NDA in 3Q:13 and GAIN accelerated
approval by mid'14. We see tedizolid as a differentiated MRSA drug and Trius as a
potential acquisition candidate. We reiterate our Overweight rating and $13 price target.
• Derisked Tedizolid Data Only Months Away. The primary value driver for Trius
remains data from the ESTABLISH-2 trial (n=~667) by early 2Q:13 comparing
tedizolid to Zyvox in ABSSSI. Enrollment will be more evenly balanced between the
U.S. and Europe, likely benefiting tedizolid, which does better in patients with cellulitis
and larger lesions. Assuming positive results, Trius intends to file an NDA in 3Q:13
and tedizolid could be approved under the GAIN Act by mid-2014, at least 12 months
ahead of Zyvox going generic. We now expect Trius to seek a partner for tedizolid in
Europe after ESTABLISH-2 data, bringing in non-dilutive funding and sharing future
development costs.
• Differentiated MRSA Drug. Tedizolid is administered 200mg QD x 6 days while Zyvox
is 600mg BID x 10 days. This lower pill burden and shorter duration should benefit
compliance. In ESTABLISH-1, tedizolid had less of an impact on platelets (9.2% vs.
14.9%), and fewer GI disorders (16.3% vs 25.4%, p=0.004). Tedizolid appears well
positioned against Zyvox and Cubicin, making Trius a likely take-out candidate by
either Pfizer (PFE) or Cubist (CBST) to defend their franchises.
• Other Near-term Milestones. We look for partner Bayer to begin Phase III trials of
tedizolid in Japan in January and Trius to begin Phase III pneumonia trials in 2013.
• New Gyrase Program Represents Huge Potential. Trius is developing a preclinical
dual DNA Gyrase B (GyrB) and Topoisomerase IV E (ParE) program representing an
entirely new class of drugs with broad gram-positive and gram-negative activity. The
program is fully funded through Phase I under a $28 million NIAID contract, and
could enter the clinic in 2013.
R I S K S T O A C H I E V E M E N T O F P R I C E TA R G E T
Tedizolid may fail in pivotal trials or to gain approval. Trius may not partner tedizolid
and require additional capital.
C O M P A N Y D E S C R I P T I O N
Trius is developing antibiotic drugs including tedizolid for gram+ infections.
Piper Jaffray
C O M P A N Y N O T E
D e c e m b e r 1 3 , 2 0 1 2
Trius Therapeutics, Inc. (TSRX) Overweight
Top Pick for 2013 Ahead of Pivotal ESTABLISH-2 Data in 1H:13
PRICE: US$4.58
TARGET: US$13.00
Changes Previous Current
Rating — Overweight
Price Tgt — US$13.00
C O N C L U S I O N
2012 has been a memorable year for biotech. Recently though investors have become
more defensive, locking in gains and taking year-end profits. We look to hit the "reset"
button on January 1st. Despite macro issues such as the fiscal cliff taking center stage,
we expect the robust productivity of the biotech sector to result in new drug approvals
and launches, driving profitability and continued M&A. Trius is one of our Top Picks
for 2013. The primary value driver for Trius remains data from the ESTABLISH-2 trial
by early 2Q:13. Trius remains on track to file an NDA in 3Q:13 and GAIN accelerated
approval by mid'14. We see tedizolid as a differentiated MRSA drug and Trius as a
potential acquisition candidate. We reiterate our Overweight rating and $13 price target.
• Derisked Tedizolid Data Only Months Away. The primary value driver for Trius
remains data from the ESTABLISH-2 trial (n=~667) by early 2Q:13 comparing
tedizolid to Zyvox in ABSSSI. Enrollment will be more evenly balanced between the
U.S. and Europe, likely benefiting tedizolid, which does better in patients with cellulitis
and larger lesions. Assuming positive results, Trius intends to file an NDA in 3Q:13
and tedizolid could be approved under the GAIN Act by mid-2014, at least 12 months
ahead of Zyvox going generic. We now expect Trius to seek a partner for tedizolid in
Europe after ESTABLISH-2 data, bringing in non-dilutive funding and sharing future
development costs.
• Differentiated MRSA Drug. Tedizolid is administered 200mg QD x 6 days while Zyvox
is 600mg BID x 10 days. This lower pill burden and shorter duration should benefit
compliance. In ESTABLISH-1, tedizolid had less of an impact on platelets (9.2% vs.
14.9%), and fewer GI disorders (16.3% vs 25.4%, p=0.004). Tedizolid appears well
positioned against Zyvox and Cubicin, making Trius a likely take-out candidate by
either Pfizer (PFE) or Cubist (CBST) to defend their franchises.
• Other Near-term Milestones. We look for partner Bayer to begin Phase III trials of
tedizolid in Japan in January and Trius to begin Phase III pneumonia trials in 2013.
• New Gyrase Program Represents Huge Potential. Trius is developing a preclinical
dual DNA Gyrase B (GyrB) and Topoisomerase IV E (ParE) program representing an
entirely new class of drugs with broad gram-positive and gram-negative activity. The
program is fully funded through Phase I under a $28 million NIAID contract, and
could enter the clinic in 2013.
R I S K S T O A C H I E V E M E N T O F P R I C E TA R G E T
Tedizolid may fail in pivotal trials or to gain approval. Trius may not partner tedizolid
and require additional capital.
C O M P A N Y D E S C R I P T I O N
Trius is developing antibiotic drugs including tedizolid for gram+ infections.
What's your read on INSM PPS upon successfull P3 results come mid this year ? Interesting to see reputed Ayer Capital recently took a large stake in INSM.
Current pps is also below the price many of the insiders bought. Also like the automatic insiders buy program CEO has instituted.
Thanks
"The Biotech Buyout Binge" research report.
This a very tiny biotech - essentially a "penny" stock. But it's a penny stock with a lot of promise.
The company is Inovio Pharmaceuticals Inc. (NYSE: INO), a Blue Bell, Penna.-based venture that's working on synthetic vaccines for cancers and for infectious diseases.
At first glance - with a market cap of roughly $92 million and a stock that's trading at 66 cents a share - Inovio looks like the classic penny stock. And because the company currently has no sales, the initial impression is certainly that of an early-stage, penny stock biotech.
But this is why there's such great value in having access to the insights of a high-tech guru - who's able to tell us that there's much more to the Inovio story than most investors think.
"While it's true that Inovio has no sales at present, what's more important to note is that this is a company that's still been able to finance its operations because it has done a superb job raising money from both government sources and foundations," Michael said. "What that tells us is that Inovio has great science. You see, the folks in charge of the funding are able to differentiate between hype and promise, and they can see that Inovio's science has great promise."
Indeed, Inovio's anti-malarial-vaccine initiative has received millions of dollars in funding from a group affiliated with Bill and Melinda Gates. That's been enough to help finance the clinical trials it's pursuing, and to continue its research-and-development efforts.
The biotech is working on vaccines for cervical cancer and leukemia. And it has an injection-enhancing technology that it refers to as "electroporation." As you'll see, that technology is pretty intriguing.
"When a patient gets an injection ... a shot ... they also receive a quick electric pulse," Michael explained. "That pulse causes cell membranes to open and accept the DNA contained in the injection. Those cells then produce the antigens needed to tell the immune system to fight that particular, targeted disease. It's really quite ingenious."
But it was Inovio's pursuit of a "cure" for the flu - its synthetic vaccine effort - that started this conversation. I urged Michael to tell us more.
"The company is working on a "universal' flu vaccine - which is what we really need to avoid pandemic-like outbreaks," Michael told me. "Right now, vaccine-makers try to develop inoculations that are unique to the current flu season. That means they have to be developed, manufactured and distributed as quickly as possible. And if they "miss' and don't match the vaccine to the virus, or if a new strain of virus emerges, the vaccine isn't effective, and it's usually too late to develop a new one."
The obvious solution is to create an influenza vaccine that can protect us from existing and newly emergent "unmatched" strains of the virus. Lots of companies are trying to do this, and it's also one of Inovio's key goals.
"What we really need to see is a vaccine that can give us protection against current, known strains of the flu - and pre-emptive protection against strains that could emerge," Michael told me. "It takes a unique technology to achieve that objective. And that's what Inovio is trying to do with its "synthetic consensus' design approach - also known as its "SynCon®' technology."
To form their "Buy, Sell or Hold" ratings, most tech analysts read whitepapers, troll news sites, read stock charts, attend trade shows ... you get the idea.
But before he told me about this particular company, Michael actually had dinner with Inovio co-founder and company CEO J. Joseph Kim. So he was able to get his questions answered on a firsthand basis. And Michael also got some great insights on the biotech sector in general.
But that's another story for another time.
Analysts have a consensus target of $2 a share on Inovio
This SA article has a reference to the link. Anyway both are good
http://seekingalpha.com/article/1076261-resistance-to-resistance-is-futile-the-growing-opportunity-for-trius-and-tedizolid
Another good PR opportunity right in front of FDA !
Info for FDA forum on accelerated approval
Monday:
http://www.fda.gov/Drugs/NewsEvents/ucm335680.htm …
Speakers include $TSRX $GSK $CBST $FOLD
9:59 – 10:09 am (10:09– 10:14 am)
Jeffrey Stein, Antibiotics Working Group (AWG),
Trius Therapeutics
Good PR and agree with biospecialist post earlier on this board on EDAP potential.
Bought a significant position below 3 today. Market potential in US alone is huge. Reasonable target of $10 upon approval.
FDA usually takes 180 days per their posted guidelines before announcing the decision on PMA process.
I sold out of that position long back (with some decent profit), only to loose it all on C_SN..
Just getting more careful with where I put both my money and mouth going forward
Lol...this is exactly the mindset I had when few bears knocked on C_SN's door. Please no way I am insinuating the same with CTIX. I just need more time and need to do more homework before I get in again.
EOD, it's all about how you rotate your limited money supply
This is what happened. Took a starter position, did some more analysis and realized I need to wait for some more concrete outcome based on both trials and potential roadshows. The downside is my basis won't be as low as some of you who are already in early. No worries.
P.S: I lost a bundle on C_SN ; so need to be careful on using my meagre liquidity..another reason. Good lucks to others on CTIX, though
I will sell today (I just have a starter position of 5k that I bought at 1.89)
Thanks. I rather would get in at higher prices once PI is vetted out. The slight sliver lining is the quality & reputation of the clinical sites: Dana-Farber Cancer Institute and the Beth Israel Deaconess Medical Center.
I am more looking from th standpoint of a company doing 'dog & pony' show at reputed bio conferences such as recent JP Morgan and up coming Cowen's in early March. I would expect Dr. Menon to participate and the tell the world of the remarkable story if he truly believes and purports to be scientific power horse, he is touted to be by CTIX CEO.
Thanks to all for the explanation to my question.
If the objective is to contrast early signs of efficacy between Kevetrin with/without standard chemo and especially on drug-resistant cell lines, it definitely shows great promise.
Very interesting indeed.