This from the press release:
PRINCETON, N.J., Oct. 13, 2015 (GLOBE NEWSWIRE) -- Advaxis, Inc. (ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, today announced that three abstracts featuring Advaxis’s Lm Technology™ cancer immunotherapies have been selected for poster presentation at the Society for Immunotherapy of Cancer’s (SITC) 30th Anniversary Annual Meeting & Associated Programs, November 6-8, 2015, at Gaylord National Hotel & Convention Center in National Harbor, Md.
The poster presentations featuring Advaxis immunotherapies at SITC 2015 include:
• Cohen et al., Phase I/II study of ADXS11-001 or MEDI4736 immunotherapies alone and in combination, in patients with recurrent/metastatic cervical or human papillomavirus (HPV)-positive head and neck cancer.
• Haas et al., Phase 1-2 study of ADXS31-142 alone and in combination with pembrolizumab in patients with previously treated metastatic castration-resistant prostate cancer (mCRPC): The KEYNOTE-046 trial.
• Ghamande et al., High-dose treatment with ADXS11-001, a Listeria monocytogenes (Lm)-listeriolysin O (LLO) immunotherapy, in women with cervical cancer.
Jim, nice post, thanks for the info. I think we will see a sizable movement in price during the SITC conference, especially if those short on this one start feeling nervous that they are on the wrong side of the trade. GL2U & A. The clinical hold I think will be lifted by then, JMHO.
Mr Shet, is FOS AGAIN, LOL, where's my shocked face. How Ironic that your last name merde, turns out to be french for shet, correctly spelled of course. Whoda thunk;-)))))))))))))))))))))))))))))))))
The article is dated Oct 7th so it is a recent review of past history and reiterates that top investors are still bullish on Advaxis, which is why I posted it. I will keep your point in mind when sifting through whatever news I can find that might be worthwhile sharing.GL2U & A
This was a news article under the news tab associated with Advaxis on Yahoo Finances home page it is dated yesterday but I cut out the paragraph that might be of interest to all of you, the news is somewhat old but in spite of the recent SP performance, a reminder that some serious money is behind this company might be in order. GLTA
Hedge Funds Think Only 1 Of These 3 Trending Stocks Is Worth Buying
By Jay Smith in Market Movers,News
Published: October 7, 2015 at 11:14 am
Within our extensive database of around 730 elite funds, top investors were bullish on Advaxis, Inc. (NASDAQ:ADXS) in the second quarter. A total of 13 elite funds reported holding stakes worth $205.57 million (32.2% of the float) as of June 30, up from 12 funds and $123.68 million respectively a quarter earlier. Phill Gross and Robert Atchinson‘s Adage Capital Management increased its position by 10% to 5.64 million shares while Kevin Kotler’s Broadfin Capital raised its stake by 80% to 1.45 million shares. Samuel Isaly’s Orbimed Advisors upped its position by 76% to 755,100 shares. 25.1% of the float is short.
When the shorts decide its time to start to cover this will explode.Looking forward to the fireworks.
if ADXS, actually delivers a cure.What price a cure, when with the current standard of care the race is on which happens first, you die or go bankrupt
rEAL iMBECILE; "I learned a great deal about the investigative process." Everyone learned a long time ago, your FOS, and live in a fantasy world of your own making a BS bubble impervious to reality.
"those that say I'm crazy," No One says, they know your crazier than a loon.
"Loyal Shareholder." as loyal as a rattlesnake.BSA
i thought it might help everyone understand what has been happening to the SP in the recent past and why standing pat until this clears itself up with more information down the road, which, is likely to happen at the SITC conference in MD on Nov 4th
In the interest of providing some real information to those of us long on this equity and committed to the long term bet on its success. Hope it helps clear some of the confusion surrounding the clinical hold.
This was published by"The Smarter Analyst" today at 1:04PM by Jason Cohen,Editor
H.C. Wainwright’s healthcare analyst Swayampakula Ramakanth weighed in today with his views on Advaxis, Inc. (NASDAQ:ADXS), after the company announced that the FDA has placed a clinical hold on all four ongoing clinical studies of its experimental cancer drug after a patient died.
Ramakanth wrote, “The clinical hold was issued in response to a safety report filed by the company involving one patient who had previously enrolled in an investigator-sponsored study in 2013. Prior to her death earlier this year, the patient had tested positive for Listeria monocytogenes (Lm) in her blood. According to both the lead investigator of the study and Advaxis’ investigation, the patient’s death was caused by respiratory failure due to metastatic disease and was not related to the Lm. However, we believe that the FDA has ordered the clinical hold as a precautionary measure due to the high mortality rate associated with Lm infections, and has requested additional information regarding this event.”
“While we await the FDA’s recommendations for resolving the clinical hold, we believe that potential modifications to the studies may include: 1) excluding patients with prosthetic implants from enrolling in the studies; 2) increasing the course of antibiotics following each vaccine dose; and 3) conducting additional patient screens to ensure that Lm is no longer detectable. We do not anticipate these modifications to have any impact on the clinical outcomes of the studies,” the analyst added.
Ramakanth reiterated a Buy rating on Advaxis shares, with a price target of $30, which implies an upside of 195% from current levels.
According to TipRanks.com, which measures analysts’ and bloggers’ success
The Confusion revolves around the term clinical hold which someone else posted The study is not on a clinical hold but continuing with existing participants, which is not a clinical hold as i see it, if someone continues to receive treatment, as best as I can tell, the FDA is not involved in the decision to stop recruitment. Though i have not been able to determine why recruitment has been stopped. I would think it would be incumbent on the company management to make sure issues such as these get clarified in a timely fashion but so far mums the word from management which, might explain the wild gyrations in the SP that are occurring on large volume. i don't know how you all feel about it, but I think DOC should be saying something, no news or ambiguity is poison to a biotechs SP.
Here is the link as best as I can display it with spaces to get yahoo's message board software to allow it to post. take out the spaces and you have it
clinicaltrials dot gov/ ct2/ show/ NCT01266460? term= GOG+0265&rank=1
Here is the link as best as I can display it with spaces to get yahoo's message board software to allow it to post
clinicaltrials dot gov/ ct2/ show/ NCT01266460? term= GOG+0265&rank= 1
This is what I found doing a google search of FDa Clinical holds not sure if it is relevant but posted FYI
Under the Food and Drug Administration (FDA) regulations, an investigational new drug
application (IND) is either allowed to proceed or placed on clinical hold (21 CFR 312.42). A
clinical hold is an order issued by the FDA to the applicant to delay a proposed clinical
investigation or to suspend an ongoing investigation. A clinical hold may be either a
complete clinical hold or a partial clinical hold. An applicant may then respond to the clinical hold. Once
the applicant has submitted a complete response to the clinical hold, the Agency must evaluate the response and decide whether to lift the hold.
Section 117 of the Food and Drug Administration Modernization Act of 1997 (Modernization
Act) provides that “Any written request to the Secretary from the applicant of an investigation
that a clinical hold be removed shall receive a decision, in writing and specifying the reasons
therefor [sic], within 30 days after receipt of such request.” In addition, in conjunction with the
re authorization of the Prescription Drug User Fee Act of 1992 (PDUFA), the Agency committed
to user fee performance goals incorporating the same response time. In her letter to Congress
regarding re authorization of PDUFA, the Secretary of Health and Human Services committed the Agency to respond to an applicant’s complete response to a clinical hold within 30 calendar days of the Agency’s receipt of the applicant's complete response. Beginning in fiscal year (FY) 1998,the Agency has committed to respond to at least 75 percent of complete responses within 30 calendar days of receipt of the complete response. In FYs 1999-2002, the Agency will respond to at least 90 percent of the complete responses within 30 calendar days of receipt of the complete response.
I am not sure what Mcbridetina is talking about. Maybe I should but I don't, based on the above. Did Advaxis submit an NDA?
I just don't see a big market for the kind of low nicotine cigarette this company has developed. I agree, The idea of healthy smoke is I Think somewhat Oxymoronic. Lowering the nicotine level just simply lowers the addictive quality of smoking, So what we're going to try and succeed in making it simply a bad habit.There are plenty of other carcinogenic substances in cigarette smoke. Lower nicotine smoke versus fresh air, which is healthier?now there's a trick question.
22nd Century Group, Inc., a plant biotechnology company, focuses on tobacco harm reduction and smoking cessation products produced from modifying the nicotine content in tobacco plants through genetic engineering and plant breeding. It develops smoking cessation products and modified risk tobacco products for smokers who are unable or unwilling to quit smoking and who may be interested in cigarettes which reduce exposure to certain tobacco smoke toxins and/or pose a lower health risk than conventional cigarettes. The companys products include RED SUN and MAGIC regular and menthol cigarettes; and SPECTRUM government research cigarettes. It is also developing X-22, a prescription smoking cessation aid, which is a tobacco-based botanical medical product for use as a smoking cessation therapy; and modified risk cigarettes, such as BRAND A, which has approximately 95% less nicotine than tobacco in cigarettes, as well as BRAND B cigarettes that contains low amount of tar per milligram of nicotine. The company was founded in 1998 and is based in Clarence, New York. Currently 89cents
Did you ever spend some time in a bar called the Black rose near the Quincy market and across from the Aquarium. It was a great Irish bar.