Mike Havrilla
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178 Comments
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Electro-Optical Sciences: Positive Results for MelaFind [View article]
On Apr 13 11:06 PM hoopdreamerz@yahoo.com wrote:
> Mike, the results were horrible. This will never get approved.
Sequenom Splattered, Exact Sciences Could Benefit [View article]
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.
Updated FDA, Clinical Trial Calendars: Vion, Discovery Labs, Northfield Labs [View article]
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
> !!!!
FDA, Clinical Trial Updates: Pro-Pharma Looks Promising [View article]
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?
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 & 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'?
FDA, Clinical Trial Calendar Updates: Actelion, Merck Discontinue Partnership [View article]
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
Tracking Cancer Diagnostic and Therapeutic Stocks [View article]
On Apr 13 10:10 AM experienced wrote:
> The list shows only a relative handful of cancer related r&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.
Banking on NeoStem [View article]
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
>
>
12 Extreme FDA Trades on New Product Decisions [View article]
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.
Electro-Optical Sciences: Positive Results for MelaFind [View article]
On Apr 13 11:06 PM hoopdreamerz@yahoo.com wrote:
> Mike, the results were horrible. This will never get approved.
12 Extreme FDA Trades on New Product Decisions [View article]
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).
FDA, Clinical Trial Calendar Updates: SOMX, EPIX, HLUKY, ARKTF [View article]
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&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.
Expecting Post-Stimulus Catalyst for Stem Cell Research Companies [View article]
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
>
Cytori Therapeutics: Natural Play on Cosmetic Medicine [View article]
Javelin Pharma's Late-Stage Pipeline Pain [View article]
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!