Mike Havrilla

BioMed News: Antigenics, Shire, King Pharma, Delcath Systems

here is the actual strategy. . . provide subscribers with info on pending biomed catalysts in a calendar format, provide some examples / strategies for how to use the info in the calendar (e.g. Extreme Trading articles, including 85 single digit stocks in my most recent update), and price the service economically so retail investors can affort to subscribe.


On Oct 23 10:53 AM [e-mail] wrote:

> here's havrilla's strategy:
> * Buy before the news
> * pump it up with biomedreports and press releases
> * sell before the news.
>
> What a shameless scammer you are!
>
> <<<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.>>

BioMed News: Antigenics, Shire, King Pharma, Delcath Systems

Bam, Was having technical / IT issues with Google's blogger service so I have redirected mikehavrx.com to the ProActiveNewsRoom.com site, which already has a blog, my stock indexes, etc.

Mike


On Oct 22 10:43 PM BambamPoop wrote:

> Mike,
>
> What happened to your site? mikehavrx.com ? discontinued? or just
> temporarily down?
>
> bambampoop

BioMed News: Antigenics, Shire, King Pharma, Delcath Systems

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

BioMed News: Antigenics, Shire, King Pharma, Delcath Systems

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.

BioMed News: Antigenics, Shire, King Pharma, Delcath Systems

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.

BioMed News: Antigenics, Shire, King Pharma, Delcath Systems

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.

BioMed News: Antigenics, Shire, King Pharma, Delcath Systems

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.

Extreme FDA Trades: 30 Stocks Under 5 Bucks

JAV will be filing a NDA for Dyloject in the fall, which is already approved in Europe. The Ereska results are frustrating because of how close they were to being statistically significant so this one is up in the air whether or not a NDA will be filed.


On Aug 11 12:24 PM shave-tits wrote:

> Re: $JAV - Oh well, it happens to everyone I guess. Too bad you bought
> yesterday, and not today, you would have gained a larger qty of shares.
> Darn that crystal ball.
>
> Does this disappointing news about the trial results mean that their
> drugs will not be successful? Will they have to reengineer it, or
> do the rest results need more investigation to determine if something
> was tested wrong? How does this affect the future of $JAV, will it
> rebound, or is it viewed as a loser...?

Extreme FDA Trades: 30 Stocks Under 5 Bucks

Check out this good, recent update article for JAV:
seekingalpha.com/artic...

JAV also mentioned above in my extreme trade article for pending Ereska Phase 3 results:

Ereska is a non-opiate pain drug being developed by (1) Javelin Pharma (AMEX:JAV)($1.90) for the acute treatment of moderate to severe pain in military, trauma, post-operative, and emergency room settings with the potential for treating breakthrough pain from cancer as well. The drug is delivered by a disposable manual pump with a rapid onset and duration of pain relief of about two hours without opiate side effects such as respiratory depression. JAV expects to release the primary endpoint data from the Ereska (intranasal ketamine) Phase 3 pivotal trial in mid-2009, which consists of 220 adult patients to evaluate the safety and effectiveness of the drug in the treatment of acute pain (arising from surgery, trauma, or injury).


On Aug 10 12:23 PM shave-tits wrote:

> hi mike I just got a twt that you're buying JAV, but it didn't say
> why... can you elaborate? is a testing trial due for reporting soon?