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
This Is Worth Your Attention. Please Read It. [View instapost]
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.
Unilife: Medical Device Innovator Creating Jobs in Pennsylvania [View article]
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.
Celldex Therapeutics: Plenty of Cash, Pending Clinical Catalysts [View article]
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
Celldex Therapeutics: Plenty of Cash, Pending Clinical Catalysts [View article]
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
BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
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.>>
BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
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
NF Energy: Continuing Its Robust Growth [View article]
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.
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
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 [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.
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.
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.
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 [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.
NF Energy: Continuing Its Robust Growth [View article]
Check out NeoStem (AMEX: NBS) for a play on China pharma, stem cells / regenerative medicine, and medical tourism with its pending China Biopharma (CHBP.OB) merger: www.mikehavrx.com/2009...
As for the BioFund strategy. . . would expect NFEC to represent just one of about 20 long positions with remainder in healthcare sector, but biology in the broadest sense encompasses ecology so it is not much of a stretch to evaluate companies in the green / clean energy space for a small portion of the fund holdings (e.g. 5%).
A Primer on Pacira Pharma [View article]
Regulatory Catalyst News for ALKS, AMLN, LLY, MNKD, SVNT [View article]
This Is Worth Your Attention. Please Read It. [View instapost]
Unilife: Medical Device Innovator Creating Jobs in Pennsylvania [View article]
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.
Celldex Therapeutics: Plenty of Cash, Pending Clinical Catalysts [View article]
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
Celldex Therapeutics: Plenty of Cash, Pending Clinical Catalysts [View article]
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
BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
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.>>
BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
Mike
On Oct 22 10:43 PM BambamPoop wrote:
> Mike,
>
> What happened to your site? mikehavrx.com ? discontinued? or just
> temporarily down?
>
> bambampoop
NF Energy: Continuing Its Robust Growth [View article]
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.
BioMed News: Antigenics, Shire, King Pharma, Delcath Systems [View article]
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 [View article]
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 [View article]
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 [View article]
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 [View article]
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.
NF Energy: Continuing Its Robust Growth [View article]
www.mikehavrx.com/2009...
As for the BioFund strategy. . . would expect NFEC to represent just one of about 20 long positions with remainder in healthcare sector, but biology in the broadest sense encompasses ecology so it is not much of a stretch to evaluate companies in the green / clean energy space for a small portion of the fund holdings (e.g. 5%).