Seeking Alpha
Seeking Alpha Portfolio App for iPad
Finance
(1)

Mike Havrilla

View as an RSS Feed
View Mike Havrilla's Comments BY TICKER:
Latest  |  Highest rated
  • Electro-Optical Sciences: Positive Results for MelaFind [View article]
    Someone still disagrees with you -- MELA now flirting with 8 bucks from around $4 when I wrote the original article!


    On Apr 13 11:06 PM hoopdreamerz@yahoo.com wrote:

    > Mike, the results were horrible. This will never get approved.
    May 1 12:46 PM | Likes Like |Link to Comment
  • Sequenom Splattered, Exact Sciences Could Benefit [View article]
    Except for the fact that a blood-based screening test could be developed around EXACT's IP for the Vimentin gene.


    On May 01 08:27 AM hoopdreamerz@yahoo.com wrote:

    > Stool test for colon cancer screen will be trumped by blood based
    > tests. You can flush exas and its test down the toilet.
    May 1 09:12 AM | 1 Like Like |Link to Comment
  • Updated FDA, Clinical Trial Calendars: Vion, Discovery Labs, Northfield Labs [View article]
    Thanks!


    On Apr 27 10:09 AM R.Strauss wrote:

    > Great, better than most wordy financial newspapers. Your consice,
    > on target,get right to the bottom line.... Keep up your good work
    > !!!!
    Apr 27 11:35 AM | Likes Like |Link to Comment
  • FDA, Clinical Trial Updates: Pro-Pharma Looks Promising [View article]
    I agree the sell-off in GTXI appears over-done and like the stock in the single digits for 50-100% potential upside with FDA approval in late October. Likely to get approved with warning for small sub-group of patients and stock price should start to move up in anticipation of the PDUFA date.


    On Apr 26 09:38 AM rundowndown wrote:

    > Mike,
    >
    > Thanks for all you do. What do you think of GTXI going in to today's
    > presentation at the AUA of toremifene phase 3 clinical trial results?
    >
    >
    > The FDA is ruling on its bone drug in October. GTXI was knocked down
    > from the upper teens to below 10 in January when the EMEA said that
    > Fareston should not be used by patients at risk of prolonged QT interval
    > (this was for Orion's breast cancer drug using Fareston). GTXI got
    > knocked down by 40% since Fareston is their key drug to help prevent
    > bone loss from prostate cancer treastment, and Lazard said at the
    > time that the knockdown was overdone and kept it at a buy. EMEA say
    > the benefits outweigh the risks for the drug but wanted assurance
    > on the QT heart risk (namely Torsades de Pointes). GTXI is doing
    > QT prolongation studies as part of its NDA. With 21 years clinical
    > experiments and over 480,000 patient years with doses up to 240 mg
    > in women (who are more susceptible to the arrythmia), there have
    > been no reported cases of Torsades de Pointes.
    >
    > The stock is just under its 50 day MA at around 9.4, but there is
    > almost 40% short interest in GTXI and 26.7 days to cover, I think
    > GTXI could see a nice move next week starting Monday. It has gotten
    > back into the mid 11s twice since the EMEA news, and should the FDA
    > approve the drug in August, it will go well past the 17-18 PPS it
    > sat at before EMEA/Orion.
    >
    > I haven't seen much attention at all given to the stock heading in
    > to today's presentation other than your recent article, but do you
    > see the event as a game changer?
    >
    > Any thoughts?
    Apr 26 11:29 AM | 1 Like Like |Link to Comment
  • FDA, Clinical Trial Updates: Pro-Pharma Looks Promising [View article]

    I agree with your thoughts and would only add the potential for a takeover given their IP surrounding RNAi, $27.5M market cap, and flurry of M&A deals in the bio-pharma space ranging from micro to mega-cap deals so far this year.

    On Apr 26 08:21 AM jimmy Turano wrote:

    > Nice article Mike. I wonder if you can enlighten investors on <br/>Biotech
    > Stocks such as 'MRNA' who although this current year has made two
    > partnership deals, is dependent on collaborations/partner... but
    > is years away from any final stages or approvals. Is it best for
    > investors to buy and wait because the stock is under $1 dollar?<br/>Fina...
    > since fundamentals &amp; statistics are horrendous, and letter of
    > 'going concern' issued with De-Listing hanging in the balance currently,
    > should investors only consider the premise of 'potential' as a sole
    > method of achieving success in the future with 'MRNA'?
    Apr 26 08:32 AM | 1 Like Like |Link to Comment
  • FDA, Clinical Trial Calendar Updates: Actelion, Merck Discontinue Partnership [View article]
    If you don't want to pay 10 bucks a month then just read all of my update articles for free!


    On Apr 21 11:24 PM kamalmisc wrote:

    > Hi,
    >
    > I checked the BioMedReports.com website and to see the clinical trials
    > and calendar you need to have a subscription. At $120 is it worth
    > it?
    >
    > KC
    Apr 22 09:09 AM | Likes Like |Link to Comment
  • Tracking Cancer Diagnostic and Therapeutic Stocks [View article]
    The index is not meant to be a comprehensive list of cancer companies -- it is concentrated in the small/micro-cap space for speculative investors.


    On Apr 13 10:10 AM experienced wrote:

    > The list shows only a relative handful of cancer related r&amp;d
    > firms and gives a somewhat distorted picture. Many firms in the list
    > are in financial trouble, making it unlikely that common shareholders
    > will receive a return commensurate with risks. No timetables are
    > given for approval, other than the test phase for certain compounds.
    > There is not enough material here to make a well formed decision.
    Apr 14 05:10 AM | Likes Like |Link to Comment
  • Banking on NeoStem [View article]
    HealthShares closed all of their ETFs late last year and the Company has no products on the market at this time.


    On Apr 13 06:05 PM Minlita wrote:

    > More HealthShares EFT:
    >
    > - HealthShares™ Cardio Devices ETF - HHE
    >
    > - HealthShares™ Diagnostics ETF - HHD
    >
    > - HealthShares™ Emerging Cancer ETF - HHJ
    >
    > - HealthShares™ Enabling Technologies ETF - HHV
    >
    > - HealthShares™ Patient Care Services ETF - HHB
    >
    >
    Apr 14 05:08 AM | 1 Like Like |Link to Comment
  • 12 Extreme FDA Trades on New Product Decisions [View article]
    The upcoming FDA panel meeting will be key (6/2/09) and if it gets a positive review and rec for approval the stock could easily trade above your cost basis. However, the FDA has been tough on approving new antibiotics or even expanding the label of already approved anti-infectives over the past year so it makes for a high risk/reward trade going into the panel meeting.


    On Apr 13 08:57 PM godfreta wrote:

    > What do you think about adls. I have been holding now for three years.
    > I am dying here. My cost average is about .69 cents. Ihave 50% of
    > my savings in this company. I am physician and i CAN NOT IMAGINE
    > it failing.
    Apr 14 05:06 AM | Likes Like |Link to Comment
  • Electro-Optical Sciences: Positive Results for MelaFind [View article]
    Thats fine, the stock is still up from around 4 bucks to 6 and change in a few weeks so someone disagrees with you in addition to me!


    On Apr 13 11:06 PM hoopdreamerz@yahoo.com wrote:

    > Mike, the results were horrible. This will never get approved.
    Apr 14 04:43 AM | Likes Like |Link to Comment
  • 12 Extreme FDA Trades on New Product Decisions [View article]
    CTIC did not submit the pixantrone NDA yet:
    biomedreports.com/arti...


    On Apr 09 06:36 PM Earl who likes seeking alpha wrote:

    > You missed a major one in my opinion. CTIC, who you did mention,
    > sold their share of Zevalin in order to help cashflow for the rest
    > of the year. CTIC has pixantrone, a chemotherapy drug, which has
    > the potential to exceed Rituximab (currently a $5 bil a year drug).
    Apr 9 08:18 PM | Likes Like |Link to Comment
  • FDA, Clinical Trial Calendar Updates: SOMX, EPIX, HLUKY, ARKTF [View article]
    Check out the Global Tobacco Index of 24 cos which is included with the other health indexes at BioMedReports.com:
    biomedreports.com/heal...


    On Apr 08 09:33 AM felixd wrote:

    > I understand that Pharma is keenly focused on getting their products
    > on the FDA docket for approval but it is not much use to an investor.
    > The FDA approval process is just too slow, problematic, and almost
    > always results in a delay. Indeed, FDA approvals of new drugs is
    > a national embarrasment as fewer and fewer new drugs are being approvaed,
    > despite the fact that pharma spends huge amounts in R&amp;D.
    >
    > If you want an investible new development from the FDA it might well
    > be in cigarettes. Now that FDA looks to take over full regulation
    > of tobacco, and given the new added taxes on cigarettes, costs in
    > US for a pack are now over $5 and will likely rise some more. In
    > Mexico you can buy a pck for 20 pesos, or about a $1.80. Seems to
    > me that the better investment is in a small tobacco barn located
    > on the other side of the border in Mexico that is seeing business
    > boom thanks to US taxes and the FDA.
    Apr 8 09:37 AM | Likes Like |Link to Comment
  • Expecting Post-Stimulus Catalyst for Stem Cell Research Companies [View article]
    Please visit my website and let me know if you would like to contribute articles such as your reply below. Mike@BioMedReports.com


    On Apr 02 12:02 AM quiact wrote:

    > Over 100 years ago, a Russian histologist suggested stem cells be
    > applied for scientific research. They are the human body’s equivalent
    > of a generator, as they can renew, regenerate, and replicate under
    > the right conditions.
    >
    > The apex of cellular therapy and regenerative/reparative medicine
    > has been reborn after an 8 year moratorium that basically halted
    > federal funding for stem cell research with most states in the U.S.
    >
    >
    > Now the NIH can award grants to scientists involved with biomedical
    > research involving stem cell therapy through the CMS to each state
    > in the U.S.
    >
    > While never banned, stem cell research had limited funding during
    > this time. And this was unfortunate, because there are several likely
    > uses of stem cells.
    >
    > These uses include the replacement of tissues in the human body,
    > as well as repairing cell types that are defective. Also, stem cells
    > can deliver genetic therapies that are needed in certain patients.
    >
    >
    > ESCs are totiplotent if obtained from the morula which is a pre-blastocyst
    > stage. Normally, the stem cells are acquired from the blastocyst
    > itself. From this source, the stem cells can be any cell in the human
    > body except for the placenta, and are pluripotent.
    >
    > Embryonic stem cells are obtained from a 4 day old embryo called
    > a blastocyst, and are pluripotent from this source. The blastocyst
    > contains about 100 cells, and is not suitable at this stage for implantation
    > into the uterine wall.
    >
    > The inner core of the blastocyst has about 20 cells, and this is
    > where stem cells are obtained.
    >
    > These cells are unspecialized cells that can be developed or morphed
    > into the over 200 cells available in the human body through differentiation,
    > as ESCs are undifferentiated by nature.
    >
    > As such, they can become any human cell, as long as they are prevented
    > from clumping or crowding together when explanted into cultures as
    > they are propagated. After stem cells are cultured, they are moved
    > to what are called stem lines.
    >
    > Until recently, ESCs were believed to be most beneficial instead
    > of the adult stem cell alternative (seekingalpha.com/symbo...),
    > as these stem cells are limited to application to the tissue the
    > stem cells were obtained from only. However ASCs (somatic stem cells)
    > now can be coerced into differentiation through plasticity (trans-differentiation).
    > This likely will reduce if not eliminate those opposed to stem cell
    > therapy because of moral and ethical reasons related to the utilization
    > of ESCs.
    >
    > Thanks to molecular biology, four transcription factors control the
    > transfer of genetic information from DNA to RNAS to regulate gene
    > expression. So ASCs can have the same beneficial qualities as ESCs.
    >
    >
    > In the past, viral vectors and exotic genes interfered with the purity
    > of ASCs. Now ASCs are re-programmed using plasmids instead of viruses
    > and oncogenes that can become detrimental for the patient treated.
    >
    >
    > So now, ASCs can safely become induced pluripotent cells with the
    > same potential as ESCs. As a result, the ASCs are free of genetic
    > artifacts that potentially can interfere with transgene sequences.
    >
    >
    > They are capable of, and are able to renew and reproduce with minimal
    > effort, stem cells, under the right laboratory conditions.
    >
    > Human blood can be reproduced with stem cells under the right conditions,
    > it has been shown by researchers.
    >
    > SCT can also be used to investigate disease states for better treatment
    > options.
    >
    > Disease-specific stem cell lines, which are those cells that are
    > pluripotent and are created with the same genetic errors of certain
    > diseases, are studied for this reason.
    >
    > So there clearly is a huge potential for stem cell-based therapies.
    > The first FDA approved clinical trial occurred early in 2009. This
    > human trial will involve evaluating primarily the safety of ESCs
    > designed to be used as treatment for spinal cord injury patients.
    > The trial was submitted by Geron Corp.
    >
    > Pfizer, the largest drug company, has implemented stem cell research,
    > as they are an asset to drug discovery by creating within the organization
    > a regenerative medicine unit. Other large pharma companies are implemented
    > similar research protocols for the same reasons.
    >
    > Geron Corp. in California is the world’s leading esc developer, and
    > financed researchers at Univ. of Wisconsin, who isolated the first
    > human esc in 1998.
    >
    > Stem cell therapy potentially can cure multiple sclerosis, among
    > other disases and those with damaged human tissue. The therapy prevents
    > the advancement of disease, as well as reverses the neurological
    > dysfunctions associated with MS. Patients are injected with their
    > own stem cells obtained from their bone marrow, which are called
    > haemopoietic stem cells.
    >
    > These particular stem cells are the origin of all blood cells. Further
    > large clinical trials are needed to support these results. Studies
    > have shown between 70 and 80 percent of MS patients who received
    > stem cell therapy did not relapse afterwards.
    >
    > Allogenic, or donor transplants, have a risk of graft versus host
    > disease. Autologous, which is the patient’s own stem cells, are preferable
    > and most beneficial. Similar results from this autologous bone marrow
    > transplant cellular therapy are seen with Chron’s disease as well.
    >
    >
    > During the procedure, the immune system is reset so it is not in
    > an autoimmune state where it attacks the human body. The process
    > lasts about 2 months, and consists of 6phases:
    >
    > 1. Initial chemo
    > 2. Release of stem cells
    > 3. Acquisition of stem cells
    > 4. Cells are then frozen until ready for transplant
    > 5. Second chemo to reduce leukocytes
    > 6. Autologous stem-cell transplant. Immune system is reset.
    >
    > Positive results from stem cell therapy are seen usually within a
    > month, and patients can request another treatment about 6 months
    > after the first treatment presently. This stem cell paradigm of therapy
    > addresses the etiology of a disease state, instead of focusing on
    > the symptoms only. As such, this is the practice of regenerative
    > medicine with the implementation of SCT.
    >
    > Some believe ethical restraints are needed regarding the use of ESCs
    > for therapeutic reasons. Yet they improve the quality of life of
    > those with devastating diseases which involves suffering without
    > any relief.
    >
    > So stem cell therapy and research may be the most right and ethical
    > thing to do for such patients. Not only is the tremedous suffering
    > relieved with those possessed with devistating diseases, their functional
    > ability is restored for those who receive stem cell therapy.
    >
    > Embryos are acquired from fertility clinics (IVFs) that have thousands
    > routinely stored and are abnormally fertilized. This means that they
    > could never go on to become a human, and would be destroyed otherwise.
    >
    >
    > Ironically, one could argue it is inappropriate to discard what may
    > be valuable and ethical for others, potentially.
    >
    > Most couples with frozen embryos would gladly give them to such research,
    > surveys have concluded.
    >
    > These embryos are believed by many to not be morally equivalent to
    > human life, but only have the potential for life. And they are used
    > for therapeutic cloning, known as somatic cell nuclear transfer,
    > and not reproductive cloning.
    >
    > Ten states have banned this cloning out of ignorance, it seems. Bioethic
    > principles, which are beneficience, or physician-centered decisions,
    > as well as non-maleficence, which is first do no harm, are not corrupted.
    >
    >
    > Furthermore, autonomy, which is the patient’s right to determine
    > their health, and justice or fairness remain intact.
    >
    > Stem cells should be utilized for those terminally ill as well, many
    > believe. Many are seeking stem cell therapy overseas due to retrictions
    > that exist in the U.S. presently. The United Kingdom is believed
    > to be the leader in stem cell research p
    >
    Apr 5 08:19 AM | Likes Like |Link to Comment
  • Cytori Therapeutics: Natural Play on Cosmetic Medicine [View article]
    thanks for the continuous KOOL public service announcements!
    Mar 19 04:21 PM | Likes Like |Link to Comment
  • Javelin Pharma's Late-Stage Pipeline Pain [View article]
    My title read: Javelin Pharma: Late-Stage Pipeline Targets Pain

    biomedreports.com/arti...

    I do not work for Seeking Alpha as an editor or control what they publish! Obviously, I am bullish on JAV.


    On Mar 19 02:20 PM beginswithz wrote:

    > What a misleading headline...it sounds as if JAV is failing in late
    > stage trials! The article seems to document just the opposite.<br/>
    >
    > Consider reprinting under a different heading or retracting this
    > article!
    Mar 19 04:19 PM | Likes Like |Link to Comment
COMMENTS STATS
178 Comments
53 Likes