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Mike Havrilla

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  • BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
    dreamdivers, you can review my article archives and easily distinguish between information provided on upcoming data points, regulatory decisions, and clinical catalysts as compared to stocks that I own or write commentaries on.

    AGEN is tracked in the FDA Calendar database because it will release an update next year from the patient registry which will impact the stock price. I have never written an opinion piece on AGEN or recommended that anyone buy the stock and have only pointed it out for the pending catalysts in the form of the EMEA decision and clinical data update.

    On Oct 21 09:17 PM dreamdivers wrote:

    > So in your article today you devote an entire first paragraph to
    > summarizing the "positive" data, which you later admit comes only
    > from the company data mining retrospectively? Meanwhile, you reluctantly
    > admit only when directly questioned that pivotal trials in both RCC
    > and melanoma failed? You guys really should be ashamed, why not just
    > put on cheerleader skirts and make it official.
    Oct 21 09:37 PM | 5 Likes Like |Link to Comment
  • BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
    User 476730, Adam correctly pointed out in his article that the reason for no US approval and the negative opinion for EU approval announced today for Oncophage (aka vitespen) lies in the fact that the clinical trials did not achieve their prospective (i.e. before the trial started) primary outcomes in the pivotal Phase 3 trials that I have referenced below in melanoma and kidney cancer. "Positive data” from the trials was only generated after the fact by analyzing the data (data mining) to identify subsets of the patient population which may have benefitted from treatment in the study.

    1.) melanoma trial: J Clin Oncol. 2008 Aug 1;26(22): 3819.
    www.ncbi.nlm.nih.gov/p...

    Intention-to-treat analysis showed that overall survival in the vitespen arm is statistically indistinguishable from that in the PC arm. Exploratory landmark analyses (data mining) show that patients in the M1a and M1b substages receiving a larger number of vitespen immunizations survived longer than those receiving fewer such treatments. Such difference was not detected for substage M1c patients.

    2.) kidney cancer trial: Lancet. 2008 Jul 12;372(9633):145-54. Epub 2008 Jul 3.
    www.ncbi.nlm.nih.gov/p...

    No difference in recurrence-free survival was seen between patients given vitespen and those who received no treatment after nephrectomy for renal cell carcinoma. A possible improvement in recurrence-free survival in patients with early stage disease who received vitespen will require further validation.

    From AGEN website / PRs: The end-of-study results showed that in a substantial subset of patients (n = 362) at intermediate risk for disease recurrence (this is data mining since the substantial subset was not identified prior to the study), Oncophage demonstrated an improvement in recurrence-free survival of approximately 45 percent. For intermediate-risk patients, there was also a trend towards improved overall survival, the study’s secondary endpoint. The interim analysis from the patient registry, INSPIRE, reflects a median follow-up of 4.5 years from the largest, randomized Phase 3 kidney cancer trial ever completed to date in the adjuvant setting. The patient registry was launched in order to confirm encouraging overall survival trends observed from the Phase 3 non-metastatic kidney cancer study with final results from INSPIRE expected mid-2010.

    Mike


    On Oct 21 07:18 PM User 476730 wrote:

    > Mike:
    > Today A. Feuerstein has mentioned in The Street that Phase III trials
    > for kidney cancer and skin cancer failed in the past.
    >
    > Is that true?
    >
    > I don't know how to read the info above.
    Oct 21 08:03 PM | 5 Likes Like |Link to Comment
  • BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
    dreamdivers, there is a market for an informational database service of pending clinical trials and FDA decisions that compiles and updates this type of data for investors and traders in one location. Analyzing and writing opinions for the over 400 entries on a daily basis would be an entirely different level of service and require a full-time staff of analysts.


    On Oct 21 02:53 PM dreamdivers wrote:

    > Um Mike, rather than just regurgitating AGEN's press releases, perhaps
    > you might try explaining why the EMEA gave Oncophage such a quick
    > thumbs down. I know actual analysis is not something Biomedreports
    > is very familiar with, but you might try it sometime.
    Oct 21 03:28 PM | 4 Likes Like |Link to Comment
  • Venaxis Poised For Run-Up Into Pivotal Study Results [View article]
    CT scan is the gold standard for diagnosis and to determine if surgery is required to remove the appendix so APPY1 test would fit in between to determine if the patient is low-risk for appendicitis so that CT scan/radiation exposure is not really necessary which is especially important in younger patients at higher risk to the radiation exposure
    May 1 12:26 PM | 3 Likes Like |Link to Comment
  • Access Pharma: A Smallcap Cancer Biotech Call Option Trade [View article]
    Thanks, Jimmy -- I agree it is very important to have a low cash burn rate, mid-late stage pipeline compounds, and it is a bonus to find small/micro cap bio-pharmas with an experienced management team and approved product on the market to begin generating royalty revenues.
    May 28 10:31 AM | 3 Likes Like |Link to Comment
  • Ventrus Bio Poised For Run-Up Into Second Round Of Phase III Results [View article]
    They have presented plans to contract a specialty GI sales force that would target gastro docs so while a partnership/buyout would be much better (Salix Pharma is big into GI drugs and recently acquired Santarus so that would be the best outcome since they are in the mid-cap range so would consider a niche product like this one compared to big pharma which would never be interested), I think they could market okay on their own given a targeted audience of GI docs that is already familiar w/ the drug (compounded diltiazem) with the advantage of having a potentially FDA approved, off-the-shelf option that could be covered by third-party payers.
    Nov 27 10:17 AM | 2 Likes Like |Link to Comment
  • BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
    Fer,

    INSPIRE reflects the name of the patient registry that was launched in 2007 to confirm the survival trends and to continue collecting overall survival data observed from the Phase 3 kidney cancer study, providing an additional 3 years of data since the trial was closed. The Phase 3 trial is over, and the update next year is for the patient registry.

    Recurrence events in patients with stage I or II disease were reported in 19 (15.2%) patients in the Oncophage group and 31 (27.0%) in the observation group, which represents a patient subset with early stage disease.

    On Oct 22 02:26 PM User 476730 wrote:

    > Mike,
    > I'd like to insist if you could clarify in words that only a shmuck
    > could understand. I'm confused in regards to the kidney cancer study.
    >
    >
    > So far I believe there are some contradictions:
    >
    > Study ongoing:
    > 1. From AGEN website / PRs it seems that the Phase 3 non-metastatic
    > kidney cancer study is still ongoing with final results from INSPIRE
    > expected mid-2010.
    > Was INSPIRE the Phase III study?
    >
    > Study failed:
    > 1. "... the reason for no US approval and the negative opinion for
    > EU approval announced today for Oncophage (aka vitespen) lies in
    > the fact that the clinical trials did not achieve their prospective
    > (i.e. before the trial started) primary outcomes in the pivotal Phase
    > 3 trials that I have referenced below in melanoma and kidney cancer."
    >
    > 2. kidney cancer trial: Lancet. 2008 Jul 12;372(9633):145-54. Epub
    > 2008 Jul 3.
    > No difference in recurrence-free survival was seen between patients
    > given vitespen and those who received no treatment after nephrectomy
    > for renal cell carcinoma.
    >
    >
    > Does the following mean the study was not tested in patients with
    > early stage disease?:
    > "A possible improvement in recurrence-free survival in patients with
    > early stage disease who received vitespen will require further validation."
    >
    >
    >
    > What exactly does this mean?:
    > "Positive data” from the trials was only generated after the fact
    > by analyzing the data (data mining) to identify subsets of the patient
    > population which may have benefitted from treatment in the study.
    >
    >
    >
    > Bottom line, is phase III for kidney cancer failed and buried or
    > still ongoing with final results (from INSPIRE?) expected mid-2010?
    >
    >
    > Thanks again.
    > Fer
    Oct 22 02:44 PM | 2 Likes Like |Link to Comment
  • BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
    dreamdivers, your comments are laughable and misdirected, have you reviewed the article history for AGEN?

    seekingalpha.com/symbo...

    You don't seem to understand the difference between recommending a stock and providing info about biomed stocks with pending catalysts in a calendar database for subscribers to research further and make their own decisions.

    Not to mention the fact that I recommend a strategy (outlined in the extreme trade articles) of investing in a basket of small / micro-cap biomed stocks with pending catalysts well ahead of their binary events and selling before the event occurs.


    On Oct 22 01:34 PM dreamdivers wrote:

    > I think it's almost laughable that Havrilla is now leaving comments
    > on Feuerstein's TSCM article trying to "explain" how the EMEA managed
    > to reject Oncophage, despite the wonderful data mining results.
    Oct 22 02:24 PM | 2 Likes Like |Link to Comment
  • Access Pharma: ProLindac, MuGard Updates [View article]
    If you are for real, why weren't you at the Rodman conference asking tough questions after the presentation this past Friday -- or is your due diligence limited to looking for typos in my articles? I am open to hearing the bearish case for any of my long positions and actively seek this out as part of my research in addition to contacting my network of doctors, pharmacists, etc. in the clnical oncology space, the management teams of the company and related companies, and others in the financial/fund management space to get a full spectrum of views.


    On Sep 13 08:57 AM hoopdreamerz@yahoo.com wrote:

    > How much does Access pay you for these articles? This is an awful
    > company but maybe if you put out 1,000 pieces on it you can get it
    > up to $10.
    >
    > Recurrent isn't spelled recurarent.
    Sep 13 09:56 AM | 2 Likes Like |Link to Comment
  • Access Pharma: ProLindac, MuGard Updates [View article]
    hoopgooberz, you would have done much better to buy Access when I started covering the company and bought it in May around $1.50. There is still time to buy now with many catalysts before year-end, but you obviously have a personal vendetta against the company, me or both . . . of course I am sure that you only have the investing public's best interest fueling your anonymous stalking/posting. Maybe this will help you understand how BioMedReports earns subscriber revenue (although I doubt you will accept this) and we are not paid by the companies we cover.
    biomedreports.com/comp...




    On Sep 13 08:57 AM hoopdreamerz@yahoo.com wrote:

    > How much does Access pay you for these articles? This is an awful
    > company but maybe if you put out 1,000 pieces on it you can get it
    > up to $10.
    >
    > Recurrent isn't spelled recurarent.
    Sep 13 09:22 AM | 2 Likes Like |Link to Comment
  • Caraco Pharma Poised for a Turnaround [View article]
    So stop reading my articles -- you won't hurt my feelings and we will both be better off!


    On May 30 04:50 PM User 286452 wrote:

    > I grow weary of how you have pushed and pushed this stock over the
    > past year and how you have made great claims of its certain movement.
    > It is obvious you struggle with objectivity and it is not helpful
    > to those of us who have read your articles.
    May 30 08:39 PM | 2 Likes Like |Link to Comment
  • Cell Therapeutics' Turnaround Remains on Track [View article]
    Just keep the risk/reward in mind -- CTIC is up about 15-fold since early February when I wrote about the stock at 8 cents and there are a lot of shares outstanding. CTIC can still go higher with regulatory catalysts in 2H09, but you have to adjust your expectations given the returns already this year and the amount of common shares outstanding.


    On May 08 03:18 PM Ghaith84 wrote:

    > hi mike i need your comment on this,
    >
    > CTIC has sold its stake in zevalin and redeemed all prefered stocks,
    >
    > that means CTIC has gathered it all up and has expectations for pixantrone
    > else they wouldn't have given up the zevalin(if they don't get the
    > approval). I guess we will see this stock very high and beyond our
    > expectations , i guess 50$ is my first target but what I am really
    > concerned about is that I am holding a share that has value and prospect
    > no matter what price we will reach, I will hold till I get to my
    > price,
    >
    > NOTE: all stated is an opinion
    May 8 04:00 PM | 2 Likes Like |Link to Comment
  • Merrimack Poised For Post-Offering Bounce Ahead Of Phase III Results [View article]
    There is no interim analysis planned for MM-398 as per update in the recent prospectus filing so next catalysts included completing enrollment this quarter w/ top-line data to follow 4Q13-1Q14...MM-398 is a novel, stable nanotherapeutic encapsulation, or enclosed sphere carrying an active drug, of the marketed chemotherapy drug irinotecan. MM-398 achieved its primary efficacy endpoints in two Phase 2 clinical trials, one in pancreatic cancer patients and one in gastric cancer patients. We are conducting a Phase 3 clinical trial of MM-398 in patients with metastatic pancreatic cancer whose cancer has progressed on treatment with the chemotherapy drug gemcitabine. We expect to complete enrollment in the third quarter of 2013 and to announce top line results during the fourth quarter of 2013 or the first quarter of 2014…

    My price estimates are not long-term in nature or derived from discounted cash flow analysis...they are short-term trading targets based on moving averages and typical small-cap bio stock price percentage reactions to binary events such as clinical trial results or FDA decisions.
    Jul 18 09:23 AM | 1 Like Like |Link to Comment
  • Venaxis Poised For Run-Up Into Pivotal Study Results [View article]
    They expect to make initial shipments to distributors along w/ hospital marketing studies this quarter but no meaningful revenue is expected to begin until next year
    Apr 30 08:55 AM | 1 Like Like |Link to Comment
  • Amicus Therapeutics Poised For Rebound Into December Phase III Results [View article]
    below is what FOLD announced w/ 2Q12 results & during 3Q12 results announced the six-month primary endpoint data is due next month so what data is not being released?

    2Q12 results> http://bit.ly/SKBUrQ

    "Amicus and GSK have recently engaged in encouraging interactions with the FDA regarding the planned NDA for migalastat HCl. The agency indicated it would consider safety and efficacy data from both the six- and 12-month kidney biopsies to support conditional approval under subpart H. In order to preserve the integrity and availability of clinical data for the open-label follow-up period, Amicus and GSK have jointly determined that the unblinding and analysis of the data from the primary six-month treatment arm will not occur prior to the fourth quarter 2012. Both companies remain blinded to the results at this time."

    3Q12 results> http://bit.ly/RHJbXk

    During the fourth quarter 2012, Amicus and GSK expect to announce the primary endpoint analysis, based on interstitial capillary globotriaosylceramide (GL-3) as measured in kidney biopsy at 6 months. Results from the 6-month follow-up period in Study 011 are expected in the first half of 2013, which will include 12 months on migalastat HCl in the treatment group and 6 months on migalastat HCl in the placebo-crossover group.
    Nov 8 01:04 PM | 1 Like Like |Link to Comment
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