Mike Havrilla

Long-term horizon
Mike Havrilla
Long-term horizon
Contributor since: 2006
Company: BioRunUp.com
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.
FYI on the chart/trade summary section; I wrote and submitted this article on Saturday
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.
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
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
forgot to embed the six-month stock chart...
http://bit.ly/11nH9zK
tax loss selling is possible but with stock stabilizing in mid-$10s and expected near-term FDA decision for Monovisc plus expected record 4Q revenue early next year I think stock has great upside potential into year-end and through early next year.
I guess we will find out next month and there is always risk of failure in P3 trials but I don't see how either company would be hiding anything since results remained blinded to both companies...also with the timeline for the P3 results next month there is an opportunity to trade the stock for a rebound/run-up into the results as it is trading well below the 50/200-day moving averages and had a strong run-up about a month ago to mid-$6s
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.
I am hoping they give some kind of guidance to report the P3 results...would make it a great run-up trade...otherwise results could be out at any time...I ended up closing my position today with the stock in the red on big up market day and going into the weekend so will watch until their quarterly results/update
thanks, I bought a small position yesterday...may just let it ride thru results unless stock makes a big run before they are out
1) original agmt OCT 2010 $GSK purchased 6.9M shares @$4.56 which was 19.9% stake at the time
2.) $FOLD sold 11.5M shares @$5.70 in MAR 2012 which diluted $GSK's original stake
3.) expanded agmt w/ $GSK in JUL 2012 includes addt'l purchase of 2.9M shares @$6.30 bringing Glaxo ownership stake back to 19.9% w/ total ownership of 9.8M shares of $FOLD stock
is very tough to catch a falling knife and pick exact bottom...my guess is the stock drifts lower after the failed P3 trial and planned start of second P3 trial for diltiazem not expected until 4Q12...recent big gainers in biotech with near-term late-stage clinical and/or FDA catalysts...also iferanserin was main value driver for stock since diltiazem cream available from compounding pharmacies and there is already approved drug RECTIV for same indication
Amarin was developing AMR101 for other neurological indications in Phase 2 and discovered the triglyceride lowering effect indirectly in these trials and was able to proceed directly to the Phase 3 trials due to a well established safety profile and known mode of action for omega-3s to lower triglycerides. After the failed Phase 2 neuro studies, Amarin did recapitalization to support the Phase 3 trials which ended up being highly successful.
The fact that Lovaza generates about $1 billion in annual global sales clearly validates the major sales potential for more potent prescription-grade omega-3 products since omega-3 supplements have been widely available for years so NEPT is basically trying to do the same thing with krill oil and hopes to generate Phase 2 data during 2H12 to show improved results compared to regular omega-3s based on the unique features of NKO such as the phospholipid make-up and antioxidant properties. It is true Phase 3 results are a long way off but their nutraceutical biz is growing and profitable (see news today on $25 million order) on standalone basis and majority subsidiary Acasti is the R&D branch.
yeah the 510k clearance came quickly this time compared to the first drawn-out attempt! Looking at 1Q12 results, seems NEPH is closing in on break-even/profitable results w/ one remaining milestone pmt from Bellco and potential for more extensive military orders...valuation seems a bit high at over 10X sales but such an early stage that anything could happen from here
Glaxo would be natural fit assuming AMR101 gets the extended patent protection...would be a nice follow-on product to lovaza before generic competition in a few years...Pfizer would also make sense given that Lipitor went generic...I think somewhere in high teens to low twenties for fully diluted valuation around $3 billion makes sense assuming peak sales around $1 billion for AMR101 similar to Lovaza (which likely benefits from extensive off-label use by prescribers)
yeah that ship sailed long ago! I will venture to say that I have no control over ARNA share price at this point w/ the stock trading 10's millions in volume daily and I have no plans to trade it long or short
Yes, PCRX plans to conduct addt'l studies to support use of EXPAREL for nerve blocks and epidural administration--they are hoping to get premium pricing for the long-acting (72 hours) feature compared to standard formulations of bupivacaine
check out my new publishing business and website at mikehavRx.com
Justin is an excellent writer and investor, with a focus on options and stocks of innovative growth companies in the clean-tech and bio-medical space. His new website and service at RxInvestors.com is an excellent value and resources for investors.
NEH, The major investment and agreement with Sanofi (SNY) may give you some confidence, along with the manufacturing facility in Central PA.
Mike
On Nov 01 12:07 PM NEH wrote:
> I love it Mike - it's exactly the kind of under-the-radar investment
> I look for. Sadly, the manufacturing partner is in China, and I don't
> trust anything manufactured in China these days.
Hope8610, As I posted in the previous comment, I believe the science will ultimately make CLDX a winner, but the downturn in the stock price has been unrelenting thus far. IMUC also turned down today despite impressive Phase 1 survival data for its cancer stem cell vaccine ICT-107.
Mike
On Oct 27 03:16 PM Hope8610 wrote:
> I bought 4000 CLDX at $8.80. will it keep going down? should I hold
> it or sell it? what
Thanks, retiredpharma -- I believe the science will ultimately make CLDX a winner, but the downturn in the stock price has been unrelenting thus far.
Mike
On Oct 24 12:02 PM retiredpharma wrote:
> Mike,
>
> I read you often and I am a bio-pharma investor! Bought Avant before
> the CLDX merger about 13 and sold all into the August 2008 run-up
> at 17-18! Got back in a bit early but average cost of shares is about
> 7 even w/ this bad recent downturn.
>
> I believe in the science of CLDX but like many I am questioning the
> silence from management. Not sure if this is a legal thing w/ the
> CRGN merger but now that the merger is behind us it seems to persist!
>
>
> I want to double down now and probably will no matter but would like
> your thoughts on this Transparency Issue...real or imagined?
>
> retiredpharma
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 hoopdreamerz@yahoo.com 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.>>
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
dual cit, thanks for the heads up on Starpharma and I will take a closer look. I have been following Unilife Medical (UNIFF.PK) since early this year and the stock is doing well -- the Company is also relocating near me in Central PA from Australia.
Mike
On Oct 22 08:56 PM dual cit wrote:
> Mike, perhaps you can begin to follow some of the more exciting biopharma
> companies coming out of Australia. For example, Starphama (ADR: seekingalpha.com/symbo...).
> I believe your followers would benefit greatly from your knowledge
> here.
>
> Disclosure: We are one of the original VC's of this company and are
> long.
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
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.
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.
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.
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.