Here it STATES That they did not need to continue to enroll all 74 patients because the first phase of the enrollment had such HIGH improvements that they stopped the trial early to move on to phase III without enrolling the remainder of patients. This happens when proof of their trial objective was more than expected and passed their primary objective for safety and tolerability.
All this is very encouraging...Anyone thinking different can not comprehend what the meaning and significance of this trial assessment was about. Not many phase II trials can end early with a FDA
The HOPEMD study was designed as a proof-of-concept open-label clinical study in 74 patients for 24 weeks, following which all patients would be randomized into a treatment arm or non-treatment control group, and followed for an additional 12 months in a continuation study. The primary objective was to assess the safety and tolerability of Cabaletta. Secondary endpoints were to determine if Cabaletta improves or prevents worsening of OPMD disease markers. As previously reported, based on the positive signals seen in the first 25 patients enrolled in Canada and Israel, further recruitment has been terminated, with the aim of beginning a Phase 3 study. These 25 patients remain in the Phase 2 study. To date, 22 patients have completed 24 weeks of treatment. Of these patients, 19 have now been randomized into the continuation study. Although unplanned, an analysis was done on clinical data accumulated as of September 1, 2015 on these 25 patients.
In this analysis, Cabaletta was observed to be safe and well-tolerated with no drug-related serious adverse events
NOTE: Seven baseline VFS-PAS measurements recorded in Israel were uninterpretable due to faulty radiological procedure and were excluded from the interim data set. (This happens in some trials. That's why they have trials in different locations to compare data. It's a shame this happens as much as it does.)
Sentiment: Strong Buy
Pernix Therapeutics Patient Assistance Program. (PTX is helps people in need)
At Pernix Therapeutics, we believe that a lack of prescription insurance coverage and cost should not prevent patients from getting the medication they need. To make sure patients have access to the medications prescribed by their healthcare providers, Pernix Therapeutics is proud to offer the Pernix Therapeutics Patient Assistance Program. The Pernix Therapeutics Patient Assistance Program delivers Pernix Therapeutics selected medications at no cost to eligible patients.
TREND IS YOUR FRIEND WHEN YOU LOOK AT THE MARKET IS THERE A WIND AT YOUR BACK ? BE CAREFUL…EVEN TURKEYS CAN FLY IN A TORNADO… That's what happened in the market. To many Drug stocks ( many without revenue and positive earnings) became over rated along with many other sectors. Just like Housing/gold & oil/gas related socks. What sectors will be the next to rise or fall?
PTX does have earnings and new product growth. They are accumulating products at a cost. As their products bring in new value and revenues, PTX will see higher earnings/revenue/cash. PTX finds great deals and will continue to add more products/partners to their portfolio over time. They are also ripe for another company to buy them as they expand their products. It depends what direction they are going. Growth or Growth for buyout at much higher price.
As they say, "Trend is Your Friend"! Now find the pattern. High MA Failing in making new Highs, and Low MA making new Lows, Warns of a Trend Change......Already happened! Now we recently had, Low MA making New Lows (Bottoms) and High MA making New Highs...Warns of a Trend Change.....
So if you did not cover or buy at the bottom. $1.91, you most likely missed your best price to cover or buy...
Do NOTE that PTX's revenue trends for 2016/2017 will more than triple.....
Why because you say so? Price has already hit and bounced off a price lower than it should have gone...Greed is where you are....and that is Pathetic....
Hope you covered or went long yesterday...since Hillary's outlined drug plans have a low or little chance of success....Her remarks was just a good excuse to put a negative outlook on all drug stocks and put a scare into selling created by again, the news media. Of course the shorts picked this up and took advantage knowing this sector has been overheated for awhile.
Most drug Stocks are now appear to be oversold and have little or nowhere to go but up....
Presidential candidate Hillary Clinton outlined her plans to curtail rising drug prices. We believe her proposals have been suggested in the past by others, with limited impact on the industry. Clinton's call for Medicare to negotiate drug pricing has been suggested in the past and we see little chance of this passing a Republican controlled Congress. Clinton also calls for a $3K annual cap on out-of-pocket spend for drugs, but healthcare reform already includes a cap. Also, a R&D spending mandate will have limited impact on biotech names such as Celgene (CELG 115
The $600 billion advertising industry, which is growing at 5% rate annually, is undergoing a rapid transition. While TV ads continue to rule the roost with over 40% share, digital ads that include online desktop and mobile ads have taken the center stage and are growing at a rapid pace. According to eMarketer, Mobile advertising is the key driver of growth around the world and advertisers will spend $64.25 billion worldwide on mobile advertising in 2015, an increase of nearly 60% over 2014. So while social media platforms, search engines, programmatic ad platforms and other Internet properties stand to gain from this trend, the clear losers are the TV networks and print media that rely on advertising.
Budget allocation for online ads is increasing at the expense of TV and print media. While budget for TV ads is expected to shrink by 3% each year till 2020, print ad revenue is on a steep decline. World-wide, print ads declined 5.2% in 2014 from a year earlier and are down over 17.5% over the last five years. This leads us to believe that print ads will be relegated to the botoom tier and makeup only a small portion of the ad industry in the future. However, a turf war between TV ads and Online ads will continue in the near foreseeable future.
What Is Driving The Fundamental Shift In Ad Dollars From Traditional To Online Media?
The Internet advertising market is gaining traction owing to increasing ubiquity of smartphones, tablets and PCs, coupled with an improvement in ad measurement techniques. Internet penetration is changing user behavior and user-generated content is facilitating a move away from traditional content generation sources such as TV and printpublications. More notably, the move online is being driven by the emergence ofprogrammatic platforms that is enable advertisers to generate higher ROI for their ad dollars by matching relevant ads to websites with engaging content across geographies and time slots. Consider the following:
Sentiment: Strong Buy
This Week Could get a little Bumpy for Biotech, as Hillary moves forward with her newest Presidential campaign approach! Can her plans work? She could not get the Health Care Plan Right when she was in charge in revamping Healthcare during President Clinton term. OBAMA took office and created his own Health Care Plan in less time than Hillary could say Here's My New Health Care Plan....
Hillary's Newest Proposals:
Drug price plan could be a part of a group of health proposals from Clinton, who said Sunday on the television program "Face the Nation" that she had several ideas on health care.
"I’m going to address them this week, starting with how we’re going to try to control the cost of skyrocketing prescription drugs," she said. "It’s something that I hear about wherever I go."
The index was already vulnerable and Clinton’s tweet was likely a major factor in the decline, said John Fraunces, portfolio manager of Turner Medical Sciences Fund, said by phone. "Pricing is a theme that seems to be of growing concern in health care area, ourselves included."
Terry Haines, a political analyst with Evercore ISI, didn’t think Clinton could actually have an impact. "Regardless of what any Democratic candidate says about drug pricing, his or her ability to make that a reality as president is close to zero." Haines said in a note to clients that he doubted a drug pricing proposal could get through Congress.
Clinton's Tweet on High Drug Prices Sends Biotech Stocks Downs. Hillary Clinton tweeted Monday that she would release a plan to combat the high cost of prescription drugs.
And of course you bashers deserve to be here bickering and trying to find fault in everything about PPHM. But noticed you do not give any credit where credit is deserved....Lots of progress and new pipeline growth to continue thru end of 2015 and beyond.
Note: PPHM is now collaborating with several companies. and expanding their future pipeline with revenues they earn with their growing manufacturing plant...........
1. Peregrine and AstraZeneca Collaborate Immuno-Oncology Combination Clinical Trial--evaluate bavituximab in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736) in multiple solid tumors.
Collaboration with Memorial Sloan Kettering Cancer Center to evaluate combinations of bavituximab with other checkpoint inhibitors and immune stimulatory agents for the purpose of developing new and increasingly effective anti-cancer treatments.
2. Phase III SUNRISE Clinical Trial on Track to Complete Patient Enrollment by Calendar Year-End 2015--
3. Avid Bioservices Reports $9.4 Million in **First Quarter Revenue** (1 quarter Rev.) Higher future quarters will pay for Sunrise Phase III Trial..
4. Peregrine announced plans to expand the bavituximab clinical development program to include a Phase II trial to evaluate the combination of bavituximab and Opdivo(R) (nivolumab), an anti-PD-1 antibody, in previously treated, metastatic NSCLC. This trial is expected to be initiated by the end of calendar year 2015.
-- Peregrine announced plans to expand the bavituximab clinical development program to include a Phase II/III trial to evaluate bavituximab with chemotherapy combinations in HER2-negative metastatic breast cancer. This trial is expected to be initiated by the end of calendar year 2015.
5. New key positive findings from several recent bavituximab-focused studies.
6. Avid Bioservices Highlights: -- Avid's new manufacturing suite is fully constructed. Company plans to announce the launch.
Contract manufacturing committed backlog reached $42 million from existing customers covering services to be completed in FY 2016 and into FY 2017.
7. Corporate Highlights
-- The European Patent Office (EPO) granted Patent Number 2,269,656, licensed to Peregrine titled "Selected Antibodies Binding to Aminophospholipids and their Use in Treatment, Such as Cancer." The patent covers bavituximab as a composition of matter and for use in therapy, such as for treating cancer including in combination with radiotherapy or chemotherapy, e.g., with docetaxel. This important patent expands upon the company's intellectual property portfolio, which now numbers more than 140 worldwide issued patents and pending applications for the bavituximab oncology program.
8. Peregrine expects third-party contract manufacturing revenue for FY 2016 to be between $30 and $35 million. In addition to providing biomanufacturing services to its third-party clients, Avid will continue to support the clinical and potential commercialization of bavituximab.
9. Peregrine reported $59,016,000 in cash and cash equivalents as of July 31, 2015 compared to $68,001,000 at fiscal year ended April 30, 2015. (That’s only $11 mil less cash used. PPHM revenues FY 2016 were $9,379,000 vs expense/cost of $23,425,000 for FY 2016).
Eventually all that continued complaining about PPHM is not going to do much for your egos in the future, as PPHM continues moving forward and continues showing new positive proof and new product developments.
Jul 13, 2015 - Brean Capital Positive on Ohr Pharmaceutical (OHRP) Squalamine; Sees 1400% Upside
Sentiment: Strong Buy