How long before people are saying "I wish I would have loaded the boat when PDSB was at $3.XX, next time it drops under $5 I will definitely buy a lot more"

I know with the recent weakness going from over $7 just a couple weeks ago to half that is painful, those who have done their DD know what could be. Any single piece of positive news and this thing explodes, the question is how high does it get to? Remember at current prices the stock is < $100 million market cap, just plain crazy.

GLTA, hope the market settles down this week and we get back to moving substantially higher.

Jim, So sorry for your loss.

I received a response from Investor Relations regarding the Farmacore PR a couple of weeks ago asking why PDSB hasn't issued a PR:


PDS Info <info@pdsbiotech.com>
Wed 3/3/2021 12:28 PM

Chris,

Thank you for your question and continued support of PDS Biotech.

In November 2020, we announced that Farmacore Biotechnology had a successful pre-IND meeting with ANVISA and that we anticipated clinical trials to begin in Brazil during the first half of 2021. That timing has not changed. You can expect that we will provide further updates as the program advances meaningfully.

Best,

Deanne
Deanne Randolph

Media and Investor Relations

My original email sent today:

To: info@pdsbiotech.com <info@pdsbiotech.com>
Subject: Farmacore submission of data package

Good morning

I am an investor and PDSB and am curious why the company decided not to issue its own press release regarding this important milestone that happened 2 weeks ago? To me, this news is big and I would have expected the company to make an announcement concerning this important milestone.

You never know, it could happen tomorrow, although I won't hold my breadth. I just want to see them come out with great data on their HepB treatment. That is the real payoff if it happens and the reason I have held on so long.

Hope Reddit goes nuts with this but it likely just a few people posting about it. Been in Abus since the tkmr days. Hope it gets what it's due.

I don't understand why PDSB hasn't released a PR on the submission by Farmacore.

Farmacore PR regarding submission for approval

Brazilian company Farmacore Biotechnology announces that it has submitted the pre-clinical data package of the versamune ®-CoV-2FC vaccine for analysis by Anvisa

Thursday, 18 February 2021 10:25

Called Versamune®-CoV-2FC, the vaccine is the combination of a recombinant protein from SARS-CoV-2 itself, co-developed by Farmacore and PDS Biotech

The Brazilian company Farmacore Biotechnology, in partnership with the U.S. company PDS Biotechnology Corporation, has just submitted the regulatory data package Vaccine Versamune®-CoV-2FC against COVID-19 for analysis by ANVISA, in order to obtain agreement for the project and strategy for human testing phase 1/2. The company presented promising and robust preclinical data in tests already performed on rodents with the S1 protein associated with the Versamune vaccine platform®.

Called Versamune®-CoV-2FC, the vaccine is the combination of a recombinant protein from SARS-CoV-2 itself, co-developed by Farmacore and PDS Biotech, with the nanotechnology of the Versamune® platform by PDS Biotech, a patented technology for the activation of immune system T cells and antibody production. The vaccine is funded by the Ministry of Science, Technology and Innovations (MCTI) and is within the strategies stipulated by redevirus MCTI.

The results obtained so far demonstrate that the vaccine induces the generation of neutralizing antibodies and, at the same time, reinforces the immune response by activating the cell defense system. The expectation is that this combination – the generation of antibodies against S protein and T-cell activation – will provoke a robust immune response and offer long-term immunization, capable of tackling virus mutations.

Versamune® is a highly innovative and unique vaccine platform in its ability to promote the induction of strong CD8+ T-cell responses against viral targets. In the versamunevaccine formulation®-CoV-2FC, the use of s1 protein (which includes RBD) that contains conserved T-cell epitopes of the virus allows the induction of CD8+ and CD4+ T-cell responses directed against non-variable (conserved) regions of the virus. This approach offers potential for long-term protection against multiple virus mutations.

The project has received investment from the Ministry of Science, Technology and Innovation to perform part of the pre-clinical studies and is seeking funding for the execution of clinical trials.

Pharmacore is in contact with specific government agencies with the aim of extending pre-clinical funding to cover the next human clinical trial, scheduled to begin in the first half of 2021.

"Preclinical results demonstrated potential to induce a broad and robust immune response. We look forward to evaluating our vaccine in partnership with Farmacore in human clinical trials and to moving forward with our studies, which shows the potential for new Versamune-based vaccines®, to provide long-term protection against SARS-Cov2 (COVID 19) virus infection."

"In this global pandemic, it is the responsibility of the scientific community to be flexible and to ensure that we are prioritizing the vaccine with greater clinical potential and that we can progress more quickly," said Helena Faccioli, CEO of Farmacore. "We are excited to continue advancing in the partnership with PDS Biotech and to have the support of ANVISA to provide the opportunity to develop a treatment in Brazil in the fight against this pandemic." – complements the executive.

The companies plan to use several research and development sites in the United States and Brazil to advance the preclinical and clinical development of the vaccine. Farmacore will lead regulatory and clinical trial efforts in Brazil, while PDS Biotech will continue to contribute scientific knowledge and operational support.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with an increasing number of cancer immunotherapies and infectious disease vaccines based on the Versamune-t-cell activation technology platform ® (company intellectual property). Versamune® effectively provides disease-specific antigens for in vivo uptake and processing, in addition to activating the important immunological pathway of type 1 interferon, resulting in the production of potent "killer" T cells, as well as neutralizing antibodies. PDS Biotech has created several therapies based on combinations of Versamune® and disease-specific antigens designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About Farmacore

Farmacore is a biotechnology company founded in 2005 as a startup, focusing on research and development of innovative immunobiological products for use in the human health and veterinary sectors. It is a technology-based company that conducts research and development of biotechnological products and processes for the human and veterinary sectors. It develops innovative biotechnological and immunobiological products and adds value to them at all stages of development, from project design to the production of biomolecules www.farmacore.com.br.

About Versamune®-CoV-2FC

Versamune®-CoV-2FC is a vaccine project for COVID-19 that combines the Versamune® immune activation platform with a recombinant fusion protein developed by Farmacore from Coronavirus 2, Severe Acute Respiratory Syndrome (SARS-CoV-2) recognizable by our immune system (antigen). The target profile of the vaccine is to provide rapid induction of neutralizing antibodies, as well as "killer" T cells and memory T-cells against the SARS-CoV-2 virus, in patients vaccinated with Versamune®-CoV-2FC to protect against COVID-19 and prevent the spread of infection.

About RedeVirus MCTI

Committee created by MCTI in February 2020 that brings together experts, government representatives, ministry funding agencies, research centers and universities with the aim of integrating and implementing initiatives to combat emerging viruses, including the development of national vaccines to cope with COVID-19.


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I can't take credit for the find, someone on Twitter posted the link to the Farmacore PR. We need PDS to follow up here.

Press release issued today by partner Farmacore. Why hasn't PDS issued our own release?

Farmacore PR

Brazilian company Farmacore Biotechnology announces that it has submitted the pre-clinical data package of the versamune ®-CoV-2FC vaccine for analysis by Anvisa

Thursday, 18 February 2021 10:25

Called Versamune®-CoV-2FC, the vaccine is the combination of a recombinant protein from SARS-CoV-2 itself, co-developed by Farmacore and PDS Biotech

The Brazilian company Farmacore Biotechnology, in partnership with the U.S. company PDS Biotechnology Corporation, has just submitted the regulatory data package Vaccine Versamune®-CoV-2FC against COVID-19 for analysis by ANVISA, in order to obtain agreement for the project and strategy for human testing phase 1/2. The company presented promising and robust preclinical data in tests already performed on rodents with the S1 protein associated with the Versamune vaccine platform®.

Called Versamune®-CoV-2FC, the vaccine is the combination of a recombinant protein from SARS-CoV-2 itself, co-developed by Farmacore and PDS Biotech, with the nanotechnology of the Versamune® platform by PDS Biotech, a patented technology for the activation of immune system T cells and antibody production. The vaccine is funded by the Ministry of Science, Technology and Innovations (MCTI) and is within the strategies stipulated by redevirus MCTI.

The results obtained so far demonstrate that the vaccine induces the generation of neutralizing antibodies and, at the same time, reinforces the immune response by activating the cell defense system. The expectation is that this combination – the generation of antibodies against S protein and T-cell activation – will provoke a robust immune response and offer long-term immunization, capable of tackling virus mutations.

Versamune® is a highly innovative and unique vaccine platform in its ability to promote the induction of strong CD8+ T-cell responses against viral targets. In the versamunevaccine formulation®-CoV-2FC, the use of s1 protein (which includes RBD) that contains conserved T-cell epitopes of the virus allows the induction of CD8+ and CD4+ T-cell responses directed against non-variable (conserved) regions of the virus. This approach offers potential for long-term protection against multiple virus mutations.

The project has received investment from the Ministry of Science, Technology and Innovation to perform part of the pre-clinical studies and is seeking funding for the execution of clinical trials.

Pharmacore is in contact with specific government agencies with the aim of extending pre-clinical funding to cover the next human clinical trial, scheduled to begin in the first half of 2021.

"Preclinical results demonstrated potential to induce a broad and robust immune response. We look forward to evaluating our vaccine in partnership with Farmacore in human clinical trials and to moving forward with our studies, which shows the potential for new Versamune-based vaccines®, to provide long-term protection against SARS-Cov2 (COVID 19) virus infection."

"In this global pandemic, it is the responsibility of the scientific community to be flexible and to ensure that we are prioritizing the vaccine with greater clinical potential and that we can progress more quickly," said Helena Faccioli, CEO of Farmacore. "We are excited to continue advancing in the partnership with PDS Biotech and to have the support of ANVISA to provide the opportunity to develop a treatment in Brazil in the fight against this pandemic." – complements the executive.

The companies plan to use several research and development sites in the United States and Brazil to advance the preclinical and clinical development of the vaccine. Farmacore will lead regulatory and clinical trial efforts in Brazil, while PDS Biotech will continue to contribute scientific knowledge and operational support.

About PDS Biotechnology

PDS Biotech is a clinical-stage immunotherapy company with an increasing number of cancer immunotherapies and infectious disease vaccines based on the Versamune-t-cell activation technology platform ® (company intellectual property). Versamune® effectively provides disease-specific antigens for in vivo uptake and processing, in addition to activating the important immunological pathway of type 1 interferon, resulting in the production of potent "killer" T cells, as well as neutralizing antibodies. PDS Biotech has created several therapies based on combinations of Versamune® and disease-specific antigens designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.

About Farmacore

Farmacore is a biotechnology company founded in 2005 as a startup, focusing on research and development of innovative immunobiological products for use in the human health and veterinary sectors. It is a technology-based company that conducts research and development of biotechnological products and processes for the human and veterinary sectors. It develops innovative biotechnological and immunobiological products and adds value to them at all stages of development, from project design to the production of biomolecules www.farmacore.com.br.

About Versamune®-CoV-2FC

Versamune®-CoV-2FC is a vaccine project for COVID-19 that combines the Versamune® immune activation platform with a recombinant fusion protein developed by Farmacore from Coronavirus 2, Severe Acute Respiratory Syndrome (SARS-CoV-2) recognizable by our immune system (antigen). The target profile of the vaccine is to provide rapid induction of neutralizing antibodies, as well as "killer" T cells and memory T-cells against the SARS-CoV-2 virus, in patients vaccinated with Versamune®-CoV-2FC to protect against COVID-19 and prevent the spread of infection.

About RedeVirus MCTI

Committee created by MCTI in February 2020 that brings together experts, government representatives, ministry funding agencies, research centers and universities with the aim of integrating and implementing initiatives to combat emerging viruses, including the development of national vaccines to cope with COVID-19.


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I hope we don't see any M&A deal for awhile. If things work out great, pdsb would get some Operation Warp Speed funding of a few hundred million negating the need for any cash raise near term. After that the price would skyrocket on that news alone. Once that happens, then the greed monster in me wants them to explore M&A, not before.

GLTA, let's hope this meets or exceeds its potential in the near term. Would love to have a monster like SAVA. Best of all, the run SAVA had so far in '21 will pale in comparison to the return pdsb could have if the stars align.

Nice blocks on the bid, 2 for 50,000 shares @3.56 and 1 for 25,000 @ 3.53 currently hitting the tape. More buying to come? Things are heating up.

Couldn't help myself and talked myself into adding more at $3.52 to an already overweight position. Now makes up my 4th largest holding. Hope it skyrockets and becomes my #1 position soon. Good luck to all.

Courtesy of Albert on Twitter

100% Brazilian coronavirus vaccine enters human trials this year, scientists say


Tweet from Albert

So glad someone tweeted about a post on this board. I almost never come over to ihub even though I have a lifetime membership bought many years ago. Fress, you are a poster worth following, thank you for all your information. This is a board I definitely will be monitoring going forward.

I took a position in pdsb last year and just kept increasing it over the following months as I continued with my due diligence. I fully expect it to turn into one of my largest investments this year, at least I hope it does. Already one of my largest investments in terms of cash invested, now I just need to watch it grow. The potential is unreal considering its low float and market cap. Any 1 of the catalysts you have summarized so well come out positive and this is a 10-20 bagger or more in a heartbeat.

Good luck to all and hope it works out to its potential.

Spread to Congo, I wonder how many of the 70 who died actually died from Ebola?

Congo says two samples test positive for Ebola in northern outbreak

Sunday, August 24, 2014 12:30 p.m. CDT
KINSHASA (Reuters) - Two out of eight cases tested in an outbreak of deadly fever in the north of the Democratic Republic of Congo were positive for the Ebola virus, Health Minister Felix Kabange Numbi said on Sunday.

The World Health Organization said on Thursday that at least 70 people had died in an outbreak of hemorrhagic gastroenteritis in Congo's northern Equateur province. A WHO spokesman had said the outbreak was not Ebola.

http://www.bbc.com/news/world-africa-28922290

I am sorry for all longs and I wish you the best. Even though I have been out of the stock for several years, I still follow the ongoing legal drama with IDCC. One of these days IDCC will actually win the first round in one of its court battles. It amazes me how many times it gets smacked down in round one only to get up and win in future rounds but still not get anywhere near where it deserves. I have read too many conspiracy books and watched too many conspiracy movies to not help but think there is something bad going on behind the scenes. The individual investor sometimes doesn't stand a chance although we keep trying.

Good luck to the longs and hopefully Tuesday can bring some decent news to stop the carnage that may happen on Monday. Hopefully it isn't too bad, you have withstood way too many buying opportunities over the years. Good luck.

I still don't fully understand why Roche sold us something that is on the verge of a phase 2 especially since Curis wouldn't have bought it unless it showed promise, but I don't have to :^) They have had a very long relationship and who knows what is going on behind the scenes and what Roche's long term plans are? When they signed the agreement way back when in 2003, I believe, Roche purchased some shares of Curis, $5 million worth if my memory is correct. I wonder if they are still an investor and if that has anything at all to do with the deal? Like I said, I don't understand why a promising compound was sold by Roche for what appears to be very little but there are many reasons behind deals of this sort and it normally takes years to figure out why for the outside investors.

I know a lot has to go our way for it to happen, but I can't help but dream that a run similar to infi or pcyc will happen to our Curis one day. That is the reason why we invest in biotech's in the first place, isn't it?

INFI 2 year chart
http://finance.yahoo.com/echarts?s=INFI+Interactive#symbol=infi;range=2y;compare=;indicator=volume;charttype=area;crosshair=on;ohlcvalues=0;logscale=off;source=undefined;

PCYC 2 year chart
http://finance.yahoo.com/echarts?s=PCYC+Interactive#symbol=pcyc;range=2y;compare=;indicator=volume;charttype=area;crosshair=on;ohlcvalues=0;logscale=off;source=undefined;

IF, and I know how big a word IF is, if 427 or 907 work as we hope coupled with potential for HH plus debio and a big run could definitely happen. With Vismodegib approval IMO it reduces our downside risk and I stand behind what I have been saying for the past year after approval and that is at less than $5/share, the long term (measured in years not months) to owning Curis is limited IMO. Throw in the potential for expansion and other compounds and we could be on the verge of an explosion in the stock price. Good luck and although I thought it was a certainty that 2012 was going to be a great year for Curis, 2013 could be the year I was hoping 2012 was going to be, at least I hope so.

Bangtime, if a couple of things go our way over the coming weeks and months, there will be many longs (and shorts too) who will be kicking themselves for not loading the boat while the stock was on a 50% off sale. While I never thought we would see $4's let alone $3's and $2's after approval of Erivedge, it has made me buy a lot more shares than I ever thought I would own during the past year. Time will tell if it was a good or bad move but right now I feel pretty confident that this will turn out very good for me. Good luck and hopefully the uptrend in price continues so we can say good bye to the $3's and $4's and hello again to $5's and higher in the coming months and years.

Debiopharm begins treating patients in Phase I/II lung cancer trial

Last updated: 08/31/2012 05:06:55

Aug 31, 2012 (Datamonitor via COMTEX News Network) -- Curis, Inc., a drug development company, and Debiopharm Group, a group of companies with a focus on the development of prescription drugs, have announced that Debiopharm has begun treating patients in its HALO Phase I/II clinical trial of orally-administered Heat Shock Protein 90, or HSP90, inhibitor Debio 0932 in combination with chemotherapy regimens in patients with advanced stages of non-small cell lung cancer, or NSCLC.

The HALO, or HSP90 inhibition And Lung cancer Outcomes, study is a Phase I-II clinical trial of the safety and efficacy of the oral HSP90 inhibitor Debio 0932 in combination with standard of care, or SOC, agents in first- and second-line therapy of patients with advanced NSCLC.

On August 10, 2012, Debiopharm initiated the Phase I portion of this clinical trial designed to determine the recommended Phase II dose of Debio 0932 in combination with various chemotherapy regimens in patients with stage IIIb or IV NSCLC with disease that is characterized as wild-type EGFR (Epidermal Growth Factor). Debio 0932 will be administered in this study in combination with cisplatin/pemetrexed and cisplatin/gemcitabine in treatment-naive patients, and with docetaxel in previously treated patients.

Once a recommended Phase II dose of Debio 0932 in combination with each of the 3 chemotherapy regimens described above has been identified, the randomized, double-blind, placebo-controlled Phase II portion of this study will then begin where approximately 140 eligible patients will be randomized to receive chemotherapy with either placebo or Debio 0932.

The primary objective of the Phase II study is to determine the efficacy of Debio 0932 in combination with chemotherapy. The KRAS mutation status will also be assessed and used as a stratification factor.

HSP90 is a chaperone protein that controls the folding and processing of certain client proteins. HSP90 clients include many proteins that drive tumor development and progression, such as EGFR, HER2, c-MET, AKT, KIT, FLT3, and VEGFR. Inhibition of HSP90 leads to degradation of client proteins targeting multiple oncogenic signaling pathways.

Debio 0932 is an oral second-generation HSP90 inhibitor, which has shown extended tumor retention, blood-brain-barrier penetration, and promising anti-tumor activity both as monotherapy and in combination against a broad range of tumors in preclinical models.

"Our team is pleased to report that we have successfully advanced Debio 0932 into a large clinical trial to study its potential to provide benefit to patients suffering from non-small cell lung cancer," said Rolland-Yves Mauvernay, president and founder of Debiopharm Group, who added: "We believe that HSP90 represents an important molecular target in cancer therapy in general and in lung cancer in particular. We expect this Phase I-II study as well as the ongoing Phase Ib clinical trial to yield key data that will guide this important molecule's further development."

"Debiopharm has generated a body of clinical data with Debio 0932 to date, showing that it is generally well tolerated and that the molecule demonstrates signs of clinical activity, including a confirmed partial response that was observed in a patient with K-ras-mutated lung cancer," said Dan Passeri, Curis' president and CEO. "We believe that these data demonstrate the potential of Debio 0932 and our HSP90 inhibitor technology, and importantly, Curis is eligible for future milestone payments based on the successful achievement of specific clinical development and regulatory approval objectives under this collaboration."

http://www.citiadr.idmanagedsolutions.com/news/global_story.idms?type=scrolling&ID_NEWS=243897185

Vismodegib Reduces Tumor Burden in Nevus Syndrome

(My comment: This story was from the August issue of Clinical Oncology News but not sure when it was in the NEJM?)

From The New England Journal of Medicine

Vismodegib (Erivedge, Genentech-Curis), the recently approved orally administered hedgehog-pathway inhibitor, effectively reduces the basal cell carcinoma (BCC) tumor burden in patients with basal cell nevus syndrome (BCNS). The availability of this drug represents a significant advance in treating this rare disorder.

BCNS can cause the eruption of thousands of BCCs on a single patient, with resultant diminished quality of life and frequent scarring surgeries. The authors of this study, headed by Jean Yang, MD, PhD, of the Children’s Hospital Oakland Research Institute, in California, reasoned that vismodegib’s efficacy against BCCs might translate to efficacy against BCNS. This randomized, double-blind, placebo-controlled multicenter trial was published in The New England Journal of Medicine (2012;366:2180-2188, PMID: 22670904); the research was partially funded by Genentech. The primary end point was reduction in the incidence of new surgically eligible BCCs after three months. The secondary end point was reduction in the size of existing BCCs.

Patients were assigned in a 2:1 ratio to receive either vismodegib (150 mg per day) or placebo for up to 18 months. Patients were followed for a mean of eight months. The rate of surgically eligible BCCs was lower with vismodegib (two cases per group per year) versus placebo (29 cases; P<0.001). The size of existing BCCs also was reduced compared with baseline (–65% in the vismodegib group vs. –11% in the placebo group).

The researchers noted that in some patients in the vismodegib group all such carcinomas clinically regressed, and no tumors progressed while under treatment with the drug. Residual BCC was not detectable in 83% of biopsied samples removed from sites of clinically regressed BCCs. However, 14 of 26 (54%) patients receiving vismodegib had to discontinue treatment because of adverse events, which most frequently included loss of taste, muscle cramps, and hair and weight loss.

The authors concluded that vismodegib reduced the BCC tumor burden in patients with BCNS, and the results “confirm the essential role of the hedgehog pathway in basal-cell carcinomas.”

The study by Yang et al is the result of the discovery of the relationship between the hedgehog signaling pathway and the development of BCC in patients with BCNS by Dr. Epstein and colleagues. Patients with BCNS (Gorlin’s) develop innumerable tumors, which lead to significant morbidity because treatment options are primarily surgical. The development of vismodegib is a breakthrough for modifying the result of a defect in the tumor-suppressor gene that encodes patched 1 (PTCH1), a primary inhibitor of the hedgehog signaling pathway. The majority of sporadic BCCs (the most common cancer in the United States) have enhanced hedgehog signaling as well.

A large study in this patient population would be difficult to achieve. However, this study (N=41) showed a significant halt in the production of new tumors and reduction in the size of “surgically eligible” BCCs present at the onset of the study. One weakness of the study is the relative short time of treatment. The study was stopped because of the significant improvement in patients receiving vismodegib compared with the placebo group. Of patients receiving vismodegib, 54% stopped taking the drug due to adverse side effects including taste disturbances, muscle cramps, hair loss and weight loss. Also of note is that surgically eligible BCCs that responded to therapy recurred within months of stopping treatment.

Overall, this study confirms that vismodegib is successful in stopping the growth of BCC in patients with BCNS. This is an exciting advance for patients who until now have had few options other than surgical excision and destructive treatments: a molecularly targeted drug that helps to correct a missing tumor suppressor in patients with a genetic disease. Future studies will hopefully investigate the optimum duration of treatment and further define the patient population who will benefit from this therapy.

http://www.clinicaloncology.com/ViewArticle.aspx?d=Solid%2BTumors&d_id=148&i=August+2012&i_id=879&a_id=21513

I like both but i think even with its recent run sgen has a long run ahead. Not so sure of imgn but i still like it at these levels. I still like curis better than imgn though as you can tell.

My other favorite is SGEn followed by imgn. I am not sure which i like better cris or sgen at the moment.

Rbf keep posting. I like the fact you have experience in the field and can provide much appreciated insight to those of us who don't.

Then why don't you invest in those other companies?

bth, where do you come up with this stuff? How could you have any idea they "got the dosing all screwed up with 101"? Where in the world did you come up with a claim like this. What is your expectation of a reasonable time frame for bringing a compound from concept to approval? Just for reference, Roche with all its resources signed their agreement with Immunogen for TDM1 in 2000 and they are now on the verge of submitting for approval which could come any day now, 12 years and countless millions later. They signed the agreement with Curis in 2003 and already have the drug approved for market.

Many other companies with much more resources take far longer to bring drugs from concept through even just to a successful phase 1 than Curis has with 101. Add in the development work they did prior to offloading 0932 to debio and now that is on the verge of a phase 2 in a relatively short period of time. You surely don't have an understanding of the business you claim to be invested in. Everything they do is trial and error learning along the way. If it were easy everyone would be doing it and the success rate wouldn't be as low as it is. A company as small as Curis with the possibility of multiple successes in the future is pretty amazing IMO.

Have mistakes been made? Sure but EVERY biotech company from Curis to Roche have made mistakes. Actually every company no matter the industry or no matter how successful have made mistakes. Ever hear of the Newton from Apple? Somehow they got past it and had a fair amount of success even with the failures. Good management learns from its mistakes. The great thing is the mistakes that management at Curis have made have not caused the company to go out of business like countless other biotechs.

longcast, it really isn't our job to advertise the drug and I would defer to Roche's marketing power to know what works and doesn't. The first step is in educating the physicians and no matter what we could do on the net, it wouldn't compare with Roche's marketing department. Sales will come, we need to be patient and let it happen. It hasn't been on the market for that long AND it came early. Roche hasn't become as successful as it is without having a top notch sales team. This will succeed, hang in there.

I found the proposal I was thinking of but I was wrong about what it was concerning. Here is the proposal for a sample format of what we could propose related to Curis and stock based compensation.

http://ir.interdigital.com/secfiling.cfm?filingID=1193125-05-86621

"Mr. Michael Cohen, 11601 Wilshire Blvd, suite 500, Los Angeles, CA 90025, owner of 44,500 shares of the Company’s common stock has proposed the adoption of the following resolution and has furnished the following statement in support of his proposal exactly as it was provided to us:

Stockholder Resolution - Elect Each Director Annually

Shareholders recommend that each and every director be elected annually. This proposal recommends that our company’s governing documents, including the bylaws, be amended accordingly. The declassification shall be phased in a manner that does not affect the unexpired terms of Directors elected prior to 2005.

Proponent’s Supporting Statement

This resolution recommending annual election of all Directors is intended to promote increased accountability of Directors, reduced entrenchment of management, and increased shareholder value in the event of offers to purchase the company.

This resolution addresses the main concerns about declassified boards which were recently summarized by Ted Allen(1), Managing Director of Institutional Shareholder Services, as follows: “The ability to elect directors is the single most important use of the shareholder franchise, according to ISS and many investors. ISS believes that all directors should be accountable on an annual basis. A classified board can entrench management and effectively preclude most takeover bids or proxy contests.”

Furthermore, in its 2004 Postseason Report (2), ISS found that “No fewer that 50 firms this year offered their own binding proposals to declassify their boards. In many cases, the company’s actions led shareholders to withdraw proposals on this year’s ballot. A number of firms were responding to past majority votes on shareholder resolutions.”

The good thing about shareholder rights is that it doesn't matter if you own 1 share or a million, either could submit a proposal for the annual meeting. The bad thing is that although it could be put up for a vote, the bod could make it a non binding proposal. I will look up a proposal that was submitted to a different company I used to be involved in that another shareholder submitted about 4 years ago for a sample. It covered essentially what you are talking about. Hopefully I can find it.

Links that may be of interest although somewhat dated material:

http://www.cancerforums.net/threads/19850-New-way-to-halt-small-cell-lung-cancer?highlight=hedgehog

http://www.asco.org/ASCOv2/Home/Education%20&%20Training/Educational%20Book/PDF%20Files/2007/07lung09.pdf

http://www.cancerforums.net/threads/22377-Potential-Combination-Therapy-For-Esophageal-Cancer?highlight=hedgehog

Fred, any shareholder has the right to submit a matter to the vote of shareholders. Here is the section dealing with matters to be submitted for a vote at the annual meeting from last years proxy statement. I am all for reigning in excessive compensation and have been an outspoken critic for years about what I think is a failed experiment in compensation practices that began in the late 90's all across wall street. Unfortunately, society and institutional investors still haven't realized the true cost of stock based compensation. Until the institutions demand changes, public companies will continue to dilute investors ownership.

IMO employees should be paid in cash as their compensation and investors should be rewarded with increased prices and dividends. There should also be a requirement for members of upper management to always hold a certain amount of stock in the companies they work for and they should be required to pay for it themselves. That way they would cherish it since they paid for it and they would truly have their interests aligned with the long term interests of shareholders. They wouldn't just be looking for short term gains in stock prices as a way of cashing out during times of temporary price increases. Any officer or member of manatement with a contract should have it spelled out in their contract that by the end of X years they must purchase and hold stock equal to X times their annual compensation. That is how many partnership agreements work for newly admitted partners as far as maintaining their capital accounts. They could pay for it through discounted stock purchase plans and with cash bonuses that are truly earned not just handed out like candy.

Stockholder Proposals for 2013 Annual Meeting

Any proposal that a stockholder of Curis wishes to be considered for inclusion in our proxy statement and proxy for the 2013 annual meeting of stockholders must be submitted to our secretary at our offices, 4 Maguire Road, Lexington, MA 02421, no later than December 22, 2012.

If a stockholder of Curis wishes to present a proposal at the 2013 annual meeting, but does not wish to have the proposal considered for inclusion in our proxy statement and proxy, such stockholder must also give written notice to our secretary at the address noted above. The secretary must receive such notice not less than 60 days nor more than 90 days’ prior to the 2013 annual meeting; provided that, in the event that less than 70 days’ notice or prior public disclosure of the date of the 2013 annual meeting is given or made, notice by the stockholder must be received not later than the close of business on the 10th day following the date on which such notice of the date of the meeting was mailed or such public disclosure was made, whichever occurs first. The date of our 2013 annual meeting has not yet been established, but assuming it is held on May 30, 2013, in order to comply with the time periods set forth in our by-laws, appropriate notice for the 2013 annual meeting would need to be provided to our secretary no earlier than March 1, 2013, and no later than March 31, 2013. If a stockholder fails to provide timely notice of a proposal to be presented at the 2013 annual meeting, the proxies designated by the board will have discretionary authority to vote on any such proposal.

Here is a recently completed pancreatic study. I wonder when the results will be published considering the clinical trials website was updated in June showing it was completed? Results could come any day.

http://www.clinicaltrials.gov/ct2/show/NCT00878163?term=GDC-0449&rank=24

Vismodegib and Erlotinib Hydrochloride With or Without Gemcitabine Hydrochloride in Treating Patients With Metastatic Pancreatic Cancer or Solid Tumors That Cannot Be Removed by Surgery

This study has been completed.

First Received on April 7, 2009. Last Updated on June 17, 2012 History of Changes
Sponsor: Mayo Clinic
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00878163
Purpose
RATIONALE: Drugs used in chemotherapy, such as vismodegib and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving vismodegib together with erlotinib hydrochloride with or without gemcitabine hydrochloride may kill more tumor cells.

PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib hydrochloride when given together with vismodegib with or without gemcitabine hydrochloride in treating patients with metastatic pancreatic cancer or solid tumors that cannot be removed by surgery.


Condition Intervention Phase
Pancreatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: erlotinib hydrochloride
Drug: gemcitabine hydrochloride
Drug: vismodegib
Genetic: gene expression analysis
Genetic: polymerase chain reaction
Other: circulating tumor cell analysis
Other: immunohistochemistry staining method
Other: immunologic technique
Other: laboratory biomarker analysis
Radiation: fludeoxyglucose F 18
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Trial of the Combination of GDC-0449 and Erlotinib +/- Gemcitabine

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer
Drug Information available for: Gemcitabine Fludeoxyglucose F 18 Gemcitabine hydrochloride Erlotinib hydrochloride Erlotinib Vismodegib
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
Maximum tolerated dose of erlotinib hydrochloride when administered with vismodegib [ Designated as safety issue: Yes ]
Maximum tolerated dose of erlotinib hydrochloride when administered with vismodegib and gemcitabine hydrochloride [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
Adverse events as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
Response as assessed by modified RECIST criteria [ Designated as safety issue: No ]
Effect of treatment on selected biomarkers in circulating tumor cells and tumor biopsies [ Designated as safety issue: No ]
Effect of treatment on fludeoxyglucose F 18 positron emission tomography imaging [ Designated as safety issue: No ]
Association between clinical (toxicity and/or tumor response or activity) and biologic (pharmacodynamic) results [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: March 2009
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:

Primary

To determine the maximum tolerated dose of erlotinib hydrochloride and vismodegib with or without gemcitabine hydrochloride in patients with unresectable solid tumors.
Secondary

To describe the adverse events profile associated with these treatment regimens.
To describe the responses in patients treated with these regimens.
To assess the effect of erlotinib hydrochloride and vismodegib on selected biomarkers in circulating tumor cells and tumor biopsy samples from patients with metastatic pancreatic cancer.
To assess the effect of erlotinib hydrochloride and vismodegib on fludeoxyglucose F 18 positron emission tomography imaging in patients with metastatic pancreatic cancer.
To study the association between clinical (toxicity and/or tumor response or activity) and biologic (pharmacodynamic) results associated with erlotinib hydrochloride and vismodegib in patients with metastatic pancreatic cancer.
OUTLINE: This is a dose-escalation study of erlotinib hydrochloride.

Patients receive oral vismodegib once daily and oral erlotinib hydrochloride once daily on days 1-28. Some patients also receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients treated at the maximum tolerated dose undergo fludeoxyglucose F 18 positron emission tomography at baseline and on day 28. These patients also undergo tumor tissue and blood sample collection at baseline and periodically during study for correlative laboratory studies. Samples are analyzed for tyrosine phosphorylated or total MAP-K, EGFR, AKT, and other potential biomarkers of activity/response and for levels of genes transcriptionally activated (e.g., BCL-2, GLI, BFL-1/A1, 4-1BB, PTC1) by immunofluorescence, IHC, and quantitative-PCR.

After completion of study therapy, patients are followed at 3 months.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
DISEASE CHARACTERISTICS:

Diagnosis of 1 of the following:

Histologically confirmed malignant solid tumor (for patients enrolled in the dose-escalation or in the gemcitabine hydrochloride portion of the study)

Unresectable disease
Not amenable to any other standard therapies or patient refuses standard therapy

No known standard therapy that is potentially curative or definitely capable of extending life expectancy exists
Adenocarcinoma of the pancreas (for patients treated at the maximum tolerated dose [MTD])

Metastatic disease
Tumor amenable to biopsies AND patient willing to submit biologic samples for translational research studies
No CNS metastases unless stable for at least 2-3 months based on imaging and clinical assessment AND does not require steroids
PATIENT CHARACTERISTICS:

ECOG performance status 0-2
Life expectancy = 12 weeks
ANC = 1,500/µL
Platelets = 100,000/µL
Total bilirubin normal
Hemoglobin = 9.0 g/dL
AST = 3 times upper limit of normal (ULN)
Creatinine = 1.5 times ULN
INR normal (for patients treated at the MTD)
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during and for 12 months after completion of study treatment
Willing to complete a daily pill diary
Willing to abstain from smoking
Able to swallow or have medication administered through a G-tube and absorb the medication
No seizure disorder
Not immunocompromised (unless related to corticosteroid therapy)
No concurrent uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
No other active malignancy except nonmelanotic skin cancer or carcinoma in situ of the cervix
No myocardial infarction within the past 6 months or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias
No NYHA class III-IV congestive heart failure
No abnormalities of the cornea based on history (e.g., dry-eye syndrome, Sjögren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer's test or similar tear-production test)
PRIOR CONCURRENT THERAPY:

Recovered from all prior therapy
More than 4 weeks since prior and no concurrent chemotherapy (6 weeks for mitomycin C or nitrosoureas)
More than 4 weeks since prior and no concurrent immunotherapy or biologic therapy
More than 4 weeks since prior and no concurrent radiotherapy
No prior radiotherapy to > 25% of bone marrow
No more than 2 prior chemotherapy regimens for the current metastatic malignancy

Full dose chemotherapy used in conjunction with concurrent radiotherapy will be included as prior therapy
Prior hormonal therapy (e.g. leuprolide, aromatase inhibitors, or tamoxifen) allowed and not included as a prior chemotherapy
No previous therapy with a hedgehog inhibitor
No other concurrent ancillary therapy considered investigational (i.e., utilized for a non-FDA approved indication and in the context of a research investigation)
No concurrent CYP3A4 inhibitors or inducers
No concurrent prophylactic colony-stimulating factors
No other concurrent investigational agent that would be considered treatment for the primary malignancy
No concurrent therapy for a prior malignancy except hormonal therapy
No concurrent highly active antiretroviral therapy

The study that is the subject of the video is scheduled to be completed 12/12. I wonder when the results will be released? Will they discuss preliminary results next month during the SU2C televised event?

!


Hedgehog Inhibitors for Metastatic Adenocarcinoma of the Pancreas

This study is currently recruiting participants.

Verified March 2012 by Sidney Kimmel Comprehensive Cancer Center

First Received on March 1, 2010. Last Updated on March 25, 2012 History of Changes
Sponsor: Sidney Kimmel Comprehensive Cancer Center
Collaborators: Stand Up To Cancer
Genentech
Celgene Corporation
Information provided by (Responsible Party): Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01088815
Purpose
This is an open-label, single arm, multi-center, Phase II trial to evaluate the progression free survival in patients with metastatic adenocarcinoma of the pancreas treated with a hedgehog inhibitor (GDC-0449) in combination with chemotherapy (gemcitabine and nab-Paclitaxel).


Condition Intervention Phase
Metastatic Pancreatic Cancer
Drug: Gemcitabine, nab-Paclitaxel, GDC-0449
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Gemcitabine and Nab-Paclitaxel in Combination With GDC-0449 (Hedgehog Inhibitor) in Patients With Previously Untreated Metastatic Adenocarcinoma of the Pancreas

Resource links provided by NLM:

MedlinePlus related topics: Cancer Digestive Diseases Pancreatic Cancer Pancreatic Diseases
Drug Information available for: Pancreatin Paclitaxel Pancrelipase Gemcitabine Gemcitabine hydrochloride Vismodegib
U.S. FDA Resources

Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
To evaluate the progression free survival with the combination of GDC-0449 with Gemcitabine and nab-paclitaxel. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
• Progression free survival

To evaluate the safety of this combination in patients with metastatic adenocarcinoma of the pancreas. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
• Toxicities according to National Cancer Institute Common Toxicity Criteria for Adverse Events


Secondary Outcome Measures:
To evaluate other efficacy measures and the changes in the pancreatic cancer stem cells with the combination of GDC-0449 with gemcitabine and nab-Paclitaxel. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Overall survival
Tumor response
Pancreatic cancer stem cells in tissue and peripheral blood
Hedgehog signaling pathway downregulation


Estimated Enrollment: 80
Study Start Date: September 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
Drug: Gemcitabine, nab-Paclitaxel, GDC-0449
One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then
Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily
Detailed Description:
The emergence of new small molecules with capacity of blocking the Hedgehog signaling pathway provides a novel therapeutic approach in pancreatic adenocarcinoma treating the primary tumor, stroma, systemic metastases and pancreatic cancer stem cells by hedgehog pathway inhibition. This phase 2 clinical trial will evaluate the progression free survival (PFS) in patients with previously untreated metastatic pancreatic adenocarcinoma. We hypothesize that the combination of cytotoxic agents (gemcitabine and nab-paclitaxel) with the Hedgehog inhibitor GDC-0449 may increase PFS.

This study includes correlative studies to attempt to understand the stem cell biology and mechanism for any observed clinical benefits with the use of Hedgehog inhibitor GDC-0449. These include changes in the hedgehog pathway and changes in pancreatic cancer stem cell markers with pre and post treatment biopsies. The safety of GDC-0449 when combined with chemotherapy gemcitabine and nab-paclitaxel will also be assessed by evaluating adverse event rate.

Following the determination of eligibility patients will receive the following treatment:

One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then
Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily
Patients may continue on treatment regimen until they experience progressive disease or unacceptable toxicity, require palliative radiotherapy, withdraw consent or the physician feels it is not longer in their best interest to continue on treatment.

Eligibility

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:

Patient has histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas. Patients with islet cells tumors are excluded. Biopsy within 14 days of starting treatment.
Patient has measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan.
Patient has NOT received previous radiotherapy, surgery or chemotherapy or investigational drug therapy for the treatment of metastatic disease. If the patient received radiotherapy, chemotherapy or investigational therapy in the adjuvant setting it should be completed 3 weeks prior to enrollment. If a patient received gemcitabine in the adjuvant setting, tumor recurrence must have occurred at least six months after completing the last dose of gemcitabine
Age >18 years.
Life expectancy of greater than 1 month.
ECOG performance status 0 or 1 (Karnofsky >70%).
Patients must have adequate organ and marrow function
Exclusion Criteria:

Patient had received chemotherapy or radiotherapy for metastatic disease
Patient is receiving other investigational agents.
Patient has known brain metastases, unless previously treated and well controlled for at least three months (defined as clinically stable, no edema, no steroids and stable in 2 scans at least 4 weeks apart)
History of allergic reactions attributed to compounds of similar chemical or biologic composition to GDC-0449 or other agents used in the study.
Patients taking medications with narrow therapeutic indices that are metabolized by cytochrome P450 (CYP450), including warfarin sodium (Coumadin®) are ineligible.
Uncontrolled illness including, but not limited to, ongoing or active infection requiring IV antibiotics, symptomatic congestive heart failure not controlled with medication, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Pregnant women are excluded
Patient has undergone a major surgery, other than diagnostic surgery (i.e. surgery done to obtain a biopsy for diagnosis without removal of an organ) within four weeks prior to Day 1 of treatment on this study.
History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk from treatment complications
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088815

Contacts
Contact: Rosalind Walker, BSN 410-955-9628
Contact: Hongyan Cai, MS 410-614-4208

Locations
United States, Arizona
Translational Genomics Research Institute (TGen) Active, not recruiting
Scottsdale, Arizona, United States, 85258
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21205
Contact: Rosalind Walker, RN 410-955-9628
Contact: Hongyan Cai, MS 410-614-4208
Principal Investigator: Daniel Laheru, MD
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Amy Kramer Amy.Kramer@uphs.upenn.edu
Contact: Colleen Redlinger, BA 215-662-7687 colleen.redlinger@uphs.upenn.edu
Principal Investigator: Peter O'Dwyer, MD
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Stand Up To Cancer
Genentech
Celgene Corporation
Investigators
Principal Investigator: Daniel Laheru, MD Sidney Kimmel Comprehensive Cancer Center JHMI
Principal Investigator: Ana De Jesus-Acosta, MD Sidney Kimmel Comprehensive Cancer Center

http://www.clinicaltrials.gov/ct2/show/NCT01088815?term=GDC-0449&cond=pancreatic&rank=3

Bangtime and others. Here is a section of the terms of IHUB regarding posts subject to deletion. I hope IHUB becomes the go to site for posts about Curis but we all need to understand this site is much different than what we are used to. All members are allowed to request that deleted messages get reviewed by IHUB Admin if you think your post was deleted in error.


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They report the revenue for the same quarter Roche sells the drug. They probably receive the cash the following quarter.

BTH you said:

You're right they blew the estimated timeline. How is this any different than any other biotech company? We as shareholders want them to give us projections for things like new drugs in development and then we complain that they didn't achieve the estimate. They can't win. Although they gave us the estimated timeline, they didn't go into details as to why it was delayed. I am certain companies from Curis to Roche experience these types of delays all the time. Obviously it would have been better for them to have achieved the projection but we have no idea what held them back. I keep reminding everyone to remember what type of company Curis is, it is a small company and should not be held up to the same standards as a Roche. How many companies that are as small as Curis have a cancer drug approved? Granted Curis doesn't own the drug but they had minimal cost in the development of Erivedge and stand to reap hundreds of millions in royalties over the next several years. Not many companies the size of Curis can say the same thing.



Why won't you debate the issue? IMO it is because you don't have a valid argument. If Dan sold 50% of his holding that would say a lot. The fact that he sold less than 5% says nothing no matter how many times you post that it does. (I am going from memory as to the 5% figure, I think the figure is closer to 3%.) As I said, the problem isn't the sale, it is the fact that investors allow employees to dilute their ownership and every company does it. I didn't bother to look it up but I bet Dan received almost as many options this year as he sold stock, that is the real problem. As long as he knows he will continue to get more shares or options every year, he will continue to sell. As far as your other point about why don't they buy some, why should they? They have tons of shares and continue to hold tons of shares. Continuing to hold millions of shares tells something and that is they have faith in the future. It tells much more than the sale of a small percentage of their holdings which tells nothing.

As far as the drop in price, I don't remember where I found the article but I posted an article over on Yahoo months ago that discussed how shorts and hedge funds are following a practice of shorting stocks in companies that have recently had drug approval in the months following approval. The article said that it is due to the vast majority of the sales in the early quarters after approval don't live up to unrealistic expectations of shareholders and analysts. That sounds very reasonable to me from where I sit.

As I have posted the same thing happened to SGEN after approval of their drug last August until May of this year where it began a very nice run. The recent weakness in the stock price could be temporary as I believe or it could signal all the things you believe and it will be more permanent. I sleep very well at night and my investment in Curis doesn't worry me a bit.

BTH you said:

BTH, how do you know what all analysts were expecting as far as sales are concerned for the quarter? Please provide a link as to where there was one analyst downgrade after the quarterly results were posted to support your opinion. In addition to my knowledge Roche has yet to provide any near term projections so analysts could be doing what I did and providing unsupported guesses at this point. While the ramp up was slower than I would have hoped, according to Michael Gray the number of prescriptions written quarter to quarter grew by a factor of 4 and revenue generated from prescriptions for the quarter was actually $7-7.5 million. Not that far off estimates if you are correct with what you think analysts were expecting. If that type of growth continues the current quarter will provide some nice upside when it is reported in a couple of months.

You then said:



Again please provide a link to this. Do you work in the industry? Do you have any clue as to how many delays there are with bringing compounds to market? The sheer complexity of dealing with molecules always produces delays. I would much rather the company take its time and bring the molecule forward only after they have done as much dd into whether or not it has a good chance of success than rushing it through early testing only to have it fail.



See response above. The industry is littered with delays in bringing compounds forward. Not a big deal especially considering the size of the company and its resources it has.




Please answer this, what percentage of shares plus options did they sell that make up these large insider sales? As I have pointed out countless times before over on Yahoo, insider sales are not the problem with Curis or most other publicly traded companies. The problem is stock and option grants that are obscene. Once shareholders have allowed insiders to get these shares for free, of course they will sell occassionally. While the number of shares sold sounds like a lot to most individual investors, the reality is the sale make up a very small percentage of the number of shares they actually own. This is true throughout wall street and is not unique to Curis. So I will ask again, what percentage of shares were actually sold by insiders compared to how many shares plus options they have? I can guarantee you it makes up a relatively small percentage of their overall holdings and doesn't signal a thing as to what the future holds.



Curis is a small company with less than 40 employees with limited resources. These trials take time and they need to manage their assets prudently. Management with its limited resources helped Roche produce the first hedgehog pathway that has been approved. How long did it take Genentech with all the resources it had at its disposal to bring Erivedge to market? And remember that was approved after only a Phase 2 trial. How many years would it have taken them to bring it to market if the FDA required a phase 3? If it takes Roche this long to bring a drug to market from concept to approval, why do you have higher standards for Curis to bring drugs to market?

The approval is huge for Curis and its investors considering Roche is predicting revenue of over a Billion/year which we will make us very profitable for only the approved indication and the street gives zero value for any potential growth in Erivedge indications or potential for other compounds in development. The fact that the stock price is declining for a month doesn't mean it will be dead money for 2 years or even 2 weeks. In the biotech world this could turn around big tomorrow for all we know.

Not sure why you are so negative towards the management of a company you pretend to be heavily invested in. From my point of view they have been doing a very good job with the resources they have. I would much rather have them be prudent not only with the cash they have but also with potential dilution to existing shareholders. There are many companies with much less going for them that trade at ridiculous levels and right now IMO Curis is trading at ridiculously low levels given what it has going for it. Any day now we could get word that Erivedge is working well on pancreatic, lung or any number of other trials it is currently involved in. This alone could make the future look even brighter than where it is. In a heartbeat it could explode and for some reason the street is giving zero credit for the potential right now. I believe this will change in a very short time but if not, I am willing to wait it out.

Not sure if you will actually respond in a civil way or not now that we are not on Yahoo but I welcome a civilized debate on the issues.

I haven't listened to today's presentation yet but i just looked at the pdf on curis website. On page 2 for the oral form of 101 it shows phase 1 testing in 2nd half of 2012, not IND, but testing!! On page 3 it shows IND in 3rd Qtr. This is great. In less than 6 weeks they will be filing the ind for oral 101 with the expectation of starting the trial before year end!!!! Any day now we might get the press release of IND filing!

Operable bcc results for Erivedge due in 1st half of 2013 per page 9

How is this company trading at 4 and change?

I forgot what it looked like with cris. At least my sgen and imgn went up today and that gave me the guts to jump in with more cris. Lets hope tomorrow shows real green with our little fella.

Just don't hold me responsible :^)

I have never (well only once before) been this overweighted in a stock. Keeping my fingers crossed it works out as well as I hope. GLTA

I just hit the buy button again for another 1,000 @ 4.10. I am nuts!

Let's hope the drip, drip, drip stops now that we have another strong piece of news. While this is good news, it is not unexpected. Not really expecting much of a price reaction out of it but hopefully it stops the drip that has been happening for the past month. GLTA and it is another sign that this company is not just a one trick pony, granted that one trick is a great one, but there are other tricks up its sleeve.