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bio-guy

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  • Why I'm Upgrading AEterna Zentaris On Valuation [View article]
    I did misunderstand. 1.50 target although higher than 74 cents is still pretty soft and would be only about $100 mil MC. It really does come down to if the data is positive and how much so. My estimates are control Median OS of about 7-9 months. Hopefully AEZS-108 can replicate its 15 month median OS from the phase II. If that's the case the trial would be a slam dunk. I happen to agree with your chances of success at about 30%.

    As for dilution, 65 million isn't bad. ARNA was at 220 million shares by the time Belviq was approved.

    As for Macrilen, that NDA was most likely a ploy to raise capital on their part so I have no problem with it. The drug probably doesn't have much value outside of potential cancer-related cachexia, although that phase II seems to have been stopped.

    Regardless, you have to realize that this is a very targeted form of an already very toxic yet effective drug. This can potentially change how we treat cancer, going after specific receptors on the tumors with targeted agents. If results end how I predict they may, this has billion dollar written all over it. If it's available to buy a 1.50 with positive results that would be a "go all in" moment, similar to ACAD at $5 after positive pimavanserim results.
    Feb 10, 2015. 12:55 PM | 1 Like Like |Link to Comment
  • Why I'm Upgrading AEterna Zentaris On Valuation [View article]
    Positive results will rocket this stock. Your upside target of about 70 cents will likely come even before data is even released as people jump in for a piece of the action. The potential for AEZS-108 to treat any type of refractory LH-receptor positive cancer is HUGE. Hardest part about trading is understanding the value of your investment. You use many various calculations to get to your conclusions which grossly underestimate the true potential here. If you simplify it and take a close look at what you actually have if results are positive it's a gold mine. Doxorubicin is the most efficacious yet most toxic chemotherapeutic agent. AEZS-108 is a more potent and far less toxic version of doxorubicin. It has zero activity against LH-negative cancers which highlights it's advanced targeted mechanism of action. If this drug is approved I expect the company to go after a blanket approval for LH-receptor + cancer rather than waste years doing trials for individual cancers. That would easily make AEZS-108 a billion dollar drug and give AEZS a market cap reflective of that, rather than this pathetic smoke and mirrors MC of 35 million.

    Let me reiterate my main point. Hardest part of trading is understanding the value of your investment. This article proves my point exactly. It's a complete and total misunderstanding of the true potential here.
    Feb 10, 2015. 12:16 PM | Likes Like |Link to Comment
  • Titan Pharma Approaches Expected FDA Approval [View article]
    No delay coming. No CRL likely either. Approval with an 80% spike is my opinion. Good luck everyone, we shall wait and see
    Apr 29, 2013. 09:42 PM | 1 Like Like |Link to Comment
  • Titan Pharma: Trading The FDA Run-Up, Round 2 [View article]
    Very well written article which puts things in perspective. This stock has excellent risk vs reward considering the priority review and favorable advisory panel vote. I bought in at 1.25 prior to adcom and averaged up to 1.50 (something I rarely do) because of the excellent opportunity I saw in Titan. This is primed for explosion. The market has seen two big down days and this didn't budge a bit, actually trading higher yesterday. Nobody is giving away shares cheap and once the volume picks up this will move quickly. Look for it to cross its 50 day moving average (low 1.80s) on high volume. That will be your indication the ball's in motion. Could come tomorrow, could come next week. Either way I'd be extremely surprised if this sits at 1.80 going ink PDUFA. Place your bets ladies and gentleman, this should be a fun one.
    Apr 18, 2013. 07:14 PM | Likes Like |Link to Comment
  • A Look At One Of The Fastest Growing Industries In The Market And How To Benefit [View article]
    There is a way for pharmacists to know if patients are doctor shopping or filling scripts at other pharmacies. Its called the Control Substance Prescription Drug Monitoring Program, and most states utilize this. In Illinois, our database just merged with Indiana because they finally realized you could just drive 25 miles from Chicago and fill in Gary or some other slum in Indiana and not show up in the database. By the end of the year there is a mandate for all medical records to be electronic. I believe sometime in 2014 there will be a national database you speak of, and no, there is no privacy concern. Our database is only available for physicians, pharmacists, and other prescribing providers. They actually call your work the verify employment after you sign up. It's well encrypted, but I'm sure some wise hacker can access the info.

    TTNP looking strong. Once it breaks the 50 day moving average at 1.86 look for a gap up. I expect $2 either to come this week or next week. $3 on approval is very possible as well. You are getting great risk reward at this price of 1.80 considering a strong positive Adcom and FDA willingness to approve. The FDA knows this is a big problem as well, evident by the recent post by the commissioner Hamburg on the FDA voice blog. I think TTNP can rally all the way to its recent previous high of 2.54, and will break that on approval. A REMS delay is no concern. Unless the Earth (or stock market) is going to blow up in the next 90 days I would just hold, or even add, on a REMS delay.
    Apr 8, 2013. 08:20 PM | 1 Like Like |Link to Comment
  • Titan's Probuphine: An Effective And Promising Treatment Option [View article]
    Great article, although the stock price doesn't reflect it. This is going nowhere until larger forces decide it is. I just keep adding the further it goes down. Patience will prevail but many will sell through the blood bath. Hard to tell how low they take it before it turns around from being so far oversold. Stocks like this that trade OTC should be avoided at nearly all costs. I saw the same value you did and bought in to all this shenanigans. Fortunately I have an average of 1.40 but I wouldn't at all be surprised to see it go below that.
    Apr 2, 2013. 03:59 PM | Likes Like |Link to Comment
  • Questions That Must Be Answered For The Success Of Probuphine [View article]
    It can be controlled. It's called the prescription monitoring program. Almost every state utilizes it and providers and pharmacists have access to the informations. I am an Illinois pharmacist and are state database recently merged with Indiana. I suspect in the near future once medical records all go electronic this information will be even easier to access and all shared between states. Plus, Probuphine patients will still require monthly follow ups and many doctors will give small amounts of Suboxone for PRN breakthrough use, maybe like 10-20 tablets per month. You are unfortunately not understanding the big picture. This will get approved and trade around $3 when that happens. Afterwards a sell off to mid to low $2 is entirely possible. All that will matter then is insurance reimbursement. If docs can bill for the procedure along with the actual device they can make a fortune. Monthly follow ups to see how treatment is going and occasion PRN Suboxone scripts will make them even more money. At around 1.60 per share, TTNP is a fabulous investment. Look at ZIOP. They just failed their trial for their only drug and the company tanked around 70% yet somehow their market cap is still higher than TTNP! If this stock goes down Monday to the 1.50 level I will treat you to a fabulous Mastro's dinner because I will gladly drop another $100k at that price. the smartest investors understand the value of their investments.
    Mar 31, 2013. 11:23 AM | 2 Likes Like |Link to Comment
  • Questions That Must Be Answered For The Success Of Probuphine [View article]
    Warren Buffet stated that "a public-opinion poll is no substitute for thought". I was looking at a stock EDAP for prostate cancer when it was $1 and asked my urologist friend what he thought of their ultrasound technique cancer treatment. He said it wasn't popular and would consider it a fourth or fifth viable option. I stayed away and the stock trades at over $4 now.

    I worked many years in a chain retail pharmacy. Let me assure you that 95% of Suboxone scripts I filled were through insurance, either Medicaid or private. With that said, it would be ridiculous to think most of those people paid cash at the doctor's office. The ones that go to these "cash only" doctors are not getting Suboxone. They agree getting Norco, Vicodin, Oxy, and so on. The real issue is not whether docs will do this procedure, it's whether they will be reimbursed for it.

    I believe they will be reimbursed due to the fact that Suboxone is currently readily paid for by Medicaid and private insurers through my experience. The only way Medicaid would ever deny a prior auth for suboxone is if the controlled substance monitoring program indicated the patient was filling other opioid medications, i.e. doctor shopping.

    Furthermore, smart and money hungry docs will love Probuphine! They get to bill for the procedure and act as drug supplier, making a double whammy! And most patients will still require monthly follow up to get scripts for PRN Suboxone use (maybe few times a week). You're doctor friend is out of touch with reality and you following his one opinion makes you out of touch as well. Short away or don't buy and miss the gains. Either way it'll be a $3 stock after April 30th and probably a $5 stock by end of year.

    Disclosure: Long 220k shares at average 1.30. (I bought Tuesday after briefing docs were released and added around 1.60 after positive Adcom). Aint nobody taking any of those shares from me for a penny under $2.50
    Mar 31, 2013. 11:09 AM | Likes Like |Link to Comment
  • 3 Small Cap Biopharmas Primed To Move Much Higher Now [View article]
    ACAD had 3 phase 3 trials initiated. One failed, one terminated early, and the 3rd was a hit! They will require another phase 3 unless they get breakthrough designation and FDA allows them to submit early, but nothing of this sort has been mentioned.
    Mar 29, 2013. 10:33 AM | Likes Like |Link to Comment
  • Sarepta Therapeutics' Eteplirsen Trial: A Closer Look Reveals Clinical Uncertainty [View article]
    Put the champagne on ice fellas... Payday coming soon and more important, hope for thousands of affected children and families. No better success story than eteplirsen in my opinion.
    Mar 29, 2013. 09:23 AM | 2 Likes Like |Link to Comment
  • Sarepta Therapeutics' Eteplirsen Trial: A Closer Look Reveals Clinical Uncertainty [View article]
    "Ceredase had a less subjective clinical endpoint"

    Thanks for the highly scientific explanation! Now you make perfect sense! Less subjective indeed.

    The dystrophin productions appears to happen before a clinical response is seen. It appears to take 12-24 weeks for dystrophin production and another 12-24 weeks to see clinical benefit. We can spend 2-3 years to figure out why it is we see the great benefit we see. But in the meantime do we let kids suffering with this disease go untreated? Do we continue telling them we have nothing that works? Or do we give them a drug that has shown amazing benefit once thought unimaginable?

    Really just answer this question. If your child suffering with DMD and is 7 or 8 years old would you want them on this drug or would you want to wait and 2-3 years to know a little bit more? Just remember, there is a good posibility they will lose their abilty to walk in 2-3 years.

    Common sense prevails on this one.
    Mar 28, 2013. 09:57 PM | 5 Likes Like |Link to Comment
  • Sarepta Therapeutics' Eteplirsen Trial: A Closer Look Reveals Clinical Uncertainty [View article]
    Hey rookie, Ceredase, the nearly identical precursors to Cerezyme, was approved in 1991 with a single trial involving 12 patients. I won't provide a reference, you gotta do your own due diligence here.

    Unfortunatly two patients did progress rapidly shortly after beginning the trial. That would likely be attributed to the fact that DMD is a progressive neurodegenerative disease. Again, I won't provide the reference, gotta do your own DD.

    Reference whatever you'd like to make your point. Im sure someone will be impressed ;)
    Mar 28, 2013. 09:18 PM | 1 Like Like |Link to Comment
  • Sarepta Therapeutics' Eteplirsen Trial: A Closer Look Reveals Clinical Uncertainty [View article]
    Welcome to Seeking Alpha iBiotech. I see this is your first article, which is understandable because anyone with a reputation to maintain wouldn't go against SRPT.

    With that said, it's nice to hear an opposing view. One of my main principals in investing is to never bet on a sure thing. Articles like yours assure me that when AA comes the stock will most definately explode to the upside. Nothing wrong with your opinion here. Readers should just be sure to understand it's an opinion and not the reality. Reality is that drugs have been approved on such low numbers of patients and the FDA focuses more on data sets than size of studies. Furthermore, the reality is that no drug has ever shown to produce the results seen with eteplirsen with such a phenomenal safety profile, and advocacy groups are very vocal about that. These types of responses seen were virtually unimaginable just a year ago. Hard to bet against this one, but based on the rising short interest many would agree with you.

    AA coming and explosion to 60+ will follow. I bet the farm here from $25 a share. Contemplating $25 puts, which are very cheap now, but honestly think its a waste of money. If AA is denied, 23-25 may be as low as this goes.
    Mar 28, 2013. 08:18 PM | Likes Like |Link to Comment
  • 3 Small Cap Biopharmas Primed To Move Much Higher Now [View article]
    "and likely will not hold that gap in the short term"

    Maybe, maybe not. 6.8 million shares short according to most recent figures. A move to 70 or 80 and I'd say you're right, it likely won't hold that. A move to 50-55 and I would have to disagree. That gap will hold and it would likely trade higher afterwards.

    Only time will tell. I don't think you can wisely make any decision until the gap occurs. This is $35 now, a 50% move takes it to around $53. To sell everything at 53 or to go short at 53 would be quite dangerous in my opinion given the current short interest numbers. Shorts are playing with fire here. Anyone want to know the potential of this company then look no further at Alexion. With just half the market cap of them this trades at close to $300 a share. A 50% move up on AA announcement would attract a lot of new investors and create a lot of panic for shorts. Nothing wrong with taking profits but always remember the potential value of your investments. Selling at 53 to buy back at 73 doesn't make much sense. I'd rather hold at 53 on AA and add if it closes the gap.
    Mar 27, 2013. 02:35 PM | 1 Like Like |Link to Comment
  • An Alternative Reading Of FDA Briefing Materials On Titan's Probuphine [View article]
    Congrats to all those who held or bought through or after Tuesdays blood bath! Nice call Regexpert! I'm gonna start following you now on Seeking Alpha so I can do the opposite of what you say. You say SRPT is a bad investment as well, I'm all in on that one ;)
    Mar 21, 2013. 07:28 PM | Likes Like |Link to Comment
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