Mike Havrilla

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.

Access Pharma: A Smallcap Cancer Biotech Call Option Trade

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.

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.

Access Pharma: ProLindac, MuGard Updates

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 [e-mail] 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.

Access Pharma: ProLindac, MuGard Updates

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 [e-mail] 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.

Caraco Pharma Poised for a Turnaround

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.

Cell Therapeutics' Turnaround Remains on Track

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

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.>>

CombiMatrix: Full Array of Pending Catalysts

boris123, I think the upside is at least 2X from current levels with success on the investment bank/asset sale(s) + resolution on the legal front + windfall cash payment. Plus additional catalysts in the form of CCA data/development, Leuchemix, the prostate cancer study and NY state licensure.


On Sep 02 02:14 PM boris123 wrote:

> Mike, thanks for the writeup. So if this investment bank can help
> liquidate some of the assets you mention, what is a ballpark stock
> price given the proceeds that such sales would bring in. I infer
> that you think $7 is far too low.

7 Extreme FDA Medical Device Trades

Hardly a recommendation of Nephros -- just writing about the stocks people are trading ahead of FDA decisions. Who cares what you did or wrote 20 years ago -- it is even less relevant to traders than pending 510k applications!


On Jun 08 03:00 PM doubleshortetf wrote:

> Pimping penny stock NEPH.PB here which went from 14 to 82 cents as
> your 1st "recommendation"?
>
> Listen Class II device 510k is dime a dozen as copycat device and
> most are approved within 90 days. Now PMA is different story.
>
> So please stop pimping 510k candidates here.
>
> PS - I wrote my 1st 510k as co-op engineer for well established medical
> device company which got acquired by J&amp;J over 20 years ago. Yes,
> just about any one can write 510k.

Caraco Pharma Poised for a Turnaround

The digoxin recall didn't do much for investor confidence in management so I think most are waiting on the sidelines until the FDA makes a definitive statement regarding resolution of the Form 483 issues. Next milestone is for the formal written response by Caraco within 30 days (June 11) and then it is in the hands of the FDA for the final decision.

In the meantime, Caraco still makes money and derives about two-thirds of sales from distribution of Sun Pharma's products so they are not burning cash like a development-stage biotech while waiting for resolution of the manufacturing and quality control issues. Also, the FDA warning letter only prevents new product approvals and not products which are already on the market.


On May 30 09:30 PM thedivot wrote:

> Mike,
> The fact that the FDA found no deficiencies leads one to conclude
> (as you did) that there will be a positive resolution to the inspection
> issues. So why is the stock down? Why aren't other investors coming
> to the same 'obvious' conclusion thereby driving up the price? Is
> there something else lurking out there that is keeping the stock
> down?

Pending Clinical Trial Results: Ten Extreme Trades

Dan,

My focus is to provide info on FDA, clinical trials, and emerging small/micro-cap stocks. I am not focused on recommending stocks or tracking portfolios -- just tracking all of the info so investors/traders have a source for new ideas and pending results/decisions.

Mike


On May 14 10:53 AM Norwell wrote:

> Hi,
>
> I was wondering if there is a log of your 'portfolio' performance
> somewhere? The area of micro-bio's exploding seems interesting. I
> just can't tell if there is any logical (repeatable) approach that
> may work towards an alpha return.
>
> Dan