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Thoughts? Could be a relevant question in six or seven years when they are doing clinical trials on actual humans.
Fred,
Your ability to read between the actual facts and find the “real” story is outstanding to say the least. How lucky we all are to have you to save us all from being blindly misled by the data and press releases. You are certainly the most credible of our available resources, and your opinion is obviously very valuable. Speaking of credible opinions, may I offer two more sources...
“These data clearly demonstrate the anti-HIV-1 activity of PRO 140 in antiretroviral treatment-experienced individuals who were documented to have ongoing virus replication in the face of therapy with currently approved drugs,” said Scott M. Hammer, MD, Harold C. Neu Professor and Chief of the Division of Infectious Diseases, Columbia University Medical Center/New York-Presbyterian Hospital. “Antiviral drug resistance is an ongoing threat to HIV infected persons. Despite the dramatic progress in treatment success over the course of the epidemic, we cannot be complacent. Agents with different mechanisms of action, modes of delivery, and frequencies of administration are needed to provide patients with the options necessary to achieve and sustain virologic suppression. PRO 140 is a clear example of the advances in HIV therapeutics that can result from the dedication of developers, patients and providers to this principle.”
“The standard approach to ART therapy has been to administer combinations of oral medications that must be taken daily,” said Robert T. Schooley, MD, Professor of Medicine, Department of Infectious Diseases and Global Public Health, University of California, San Diego. “Recently, there has been increasing interest in the development of drugs that do not require daily administration. I believe that PRO 140 is a step in that direction. These PRO 140 trial findings support the potential of managing HIV by blocking its entry into T cells through a novel humanized monoclonal antibody administered in weekly subcutaneous injections. PRO 140 could provide an important new therapeutic option in suppressing a patient’s viral load as well as deterring the spread of this disease.”
Maybe you could reach out to both of these uneducated professionals to enlighten them with your wisdom as well. Again, thank you for your contributions and saving us all from being overwhelmed by the facts.
Your comments are much appreciated. I have been here for four years, participated in four private raises. I am an investor, not a trader, so SP movement is less of an issue for me. Due to NDA, I mostly remain quiet. It does however become frustrating when some post blatantly ignoring actual facts and misguide others. Your eloquent posts are much appreciated. Bottom line, the science will ultimately be what matters most. PE has proven that, now it is simply a matter of when, not if. There are many good people here, only a matter of time until the final chapter of this story is completed. Most of all, we should never lose sight of the big picture. There are many patients that will greatly benefit from this science. Ultimately we all hope to make money, but for them, they have the opportunity to regain a normal and healthy life. Best of luck to you all.
Thank you BD. Your posts are invaluable. It is certainly refreshing to have articulate conversations based on actual facts. Extremely helpful for the board. Thank you again for your time and consideration.
“Perhaps the most telling thing was the company stating that this data will help them recruit for the mono trial”
Fred, please share with us exactly where the company “stated” that information. In fact, they did not.
In fact they said, “we look forward to completing enrollment in our ongoing monotherapy trial in HIV infection.”
But you never let the facts get in the way of your opinion.
And you obviously don’t understand “p” value at all.
I could not agree more. Thank you again Tom, your experience is invaluable as you literally wrote the book on this. We are all very fortunate and I can certainly say most appreciative that you share your expertise on the technical analysis.
Well said Tom, well said indeed. Always appreciate your insight, glad to see you back. In my opinion, we are very, very close. Enjoy the ride.
If the FDA examined the data and is looking for statistical relevance, it by definition means they are attempting to prove/dis-prove an anomaly. Meaning the early data is outside of the bell curve for established treatments. From that one could infer that the early results were not only good, but game changing. If the additional patients confirm this, well, the rest will be history. Best of luck to you all, and most importantly to all of those patients in need who may very soon have a life changing option.
Saltz,
As always, thank you for your insight. Your perspective is invaluable and I could not agree more. The science is our fate, and, in my opinion that question will be answered sooner than the 4-6 week timeline. Once PE is revealed, these conversations will be much different. I believe the results will be game changing.
Thank you Dr. M. It is your opinion that matters most on this subject. Thank you again for your clarification.
Dr. M, thank you for your perspective as always. I am somewhat confused, regarding stating that the FDA has reduced the criteria from 3 to 2 classes of resistance, am I wrong or is that not what the FDA already did in the last meeting when they reduced the number of patients as well? I must be missing something, I am not clear on what the FDA has done recently to “relax” the requirements for the next 10 patients. Could you please help me to understand that piece. As always, I truly appreciate your expertise. Thank you again in advance.
Of course I read the 10Q. The company has never had difficulty raising the necessary capital to fund operations. In fact, they are being very strategic about what they raise and when. What leads you to infer that the company could not raise the necessary funds for operations and Tony was the only way? That is simply not true. I most certainly appreciate and respect your opinion, please enlighten me as to your logic.
Actually that statement is completely incorrect. To be clear, at no point was the company in a position where operations were in jeopardy due to the inability to raise capital. In fact, it is quite the opposite. The series they just closed would have given them the ability to raise an additional $9mm at current prices and they chose not to. Obviously they believe they will be able to raise at much better terms in the very near future. What Tony did was a vote of confidence, and you can be sure it was not a desperation $1mm write off. He has been at the highest levels of this industry for 38 years, he knows the value of what they have and invested accordingly.
Certainly possible. At the very least I do believe the data is going to be released soon and will be very positive. That alone would significantly change the SP and options for financing. I doubt they would close their open source of funding otherwise. Just my opinion.
In my opinion, given the amount of cash on hand, for a company that must raise capital, it means that the company believes they will be able to raise money with more favorable terms in the very near future.
Important information in the current 8k today. Section 8.01. The company has terminated the current offering for raising capital. Big news is eminent. Good luck to all.
Grip, you're in good shape. Chips are out and you are holding a strong winning hand. Never let yourself get bluffed off the table before you see the final card... Just wait. Wish you the best buddy.
Saltz,
As always, thank you for your well timed post. I could not agree more with your statements. It is in times like this where it can be difficult for some to remain committed and focused on the difference between an end game investment strategy and short term trading. It is certainly easy to understand both positions, but for those with investment strategy experience less difficult to separate. I wish you and everyone on the board all the best, and as far as my opinion, this has been a long road for many of us, but the finish line is in sight. Don't panic and fall short now, you may never forgive yourself if you do...
Don't miss the forest for the trees.
Most certainly, I know them and have met with them several times. Tony and his team are more than capable, in fact an excellent fit for completing this process. The greatest management team in the world could not be successful with poor science. My point is, the science is by far the most important component in this investment.
Yes Sir, and the key word in that statement being "investment". That is a very difficult concept for some. The real question is, what are we investing in? The answer, The Science. Given that, the next question is how is the science performing in clinical trials? The answer, outstanding thus far. Unless there is any change in that performance with the science, then any other speculation is pointless. The science is good, then your investment is rewarded, when is much less relevant than why. Best of luck to you all.
Anyone expecting a PR this morning cannot read a calendar. These posts today are comical.
"The CCR5 receptor affinity of PRO 140 is looking like it is not as potent as 3 or 4 HAART drugs...i.e. 96% efficacy, SOC and low drop out rates. "
Not one word of this statement is based on any real scientific data. Read the science as it speaks for itself.
Enough time wasted on your agenda. Just keep selling HAART and forget about the patients.
Ok, let's clear this up right now.
First, you continue to refer to the lack of 30 patients identified for the trial. You obviously do not understand the very specific parameters placed on identifying those particular patients and why. Please refer to the FDA website and actually read the requirements before you make any more misguided comments on that subject.
Second, you have absolutely NO idea what may or may not be already happening with BP. Using your logic I could just as easily say that a bidding war is currently underway. Neither statement is known to be factual.
Third and finally, at this point you have no idea what the timeline for mono will be, as no one does. There are simply too many variables, many of which will be known in the coming weeks. Enrollment is the important part now. Depending on FDA alone, the timeline could be significantly compressed. Again, we should wait for the facts. In the meantime, you should learn more about the science, and less time pushing your agenda. Best of luck to all.
Ah pears, as always your agenda speaks volumes while your posts lack facts. Nothing new there. First, the science behind PRP-140 is in no way similar to HAART, thus the term disruptive. I would suggest you begin with side effects, compliance, and resistance to name a few. As for your speculative timeline and valuation, again better to use factual information versus misguided speculation. Please do explain your position with the support of facts, as I am sure everyone would enjoy that. If HAART is perfect, wouldn't everyone be on it? This is about the patients, you should do some research on what HAART does to them...
With adjunct also comes BTD. Very important with regards to speed to market.
Done.
This will certainly not be the last of these posts with wild speculation, only the beginning. With milestones approaching, those betting against this are sitting on a ticking time bomb. Panic will set in and they will throw everything possible to slow the inevitable. In the end, the science will prevail.
Welcome back Tom, glad to see you here. Thanks as always for your input!
Extremely prophetic. Who would have ever guessed a pre-revenue biotech with multiple late stage trials would need to raise money? Never saw that coming. Great post Pears!
As always, thank you Dr M for your clinical expertise.
300+ patients have already proven that to be the case. HAART deficiencies are well documented. Maybe you should look into the science.
Blane, thank you for the excellent post, you beat me to it. Pay no attention to Pears, he/she has a different agenda. Not one of his posts have ever been factual or scientifically based, simply baseless speculation to advance an agenda. The real facts are public, and yes, as always in this type of process delays are inevitable. The facts are they missed enrollment completion by the end of Q1 as stated. The new timeline given is completion by end Q2. The enrollment challenges have absolutely nothing to do with demand or market conditions, but are the byproduct of a very specific subset for trial. We are VERY close to finding out if that has been accomplished, ten days. That would put them 90 days from the original timeline. It's hard to believe, but for some people that is an issue. Calling for the heads of management, it's laughable. The science will speak for itself. Good luck to all-
That is last years abstract. The "update" will be made public at the conclusion of the conference. What we do know is as of the March investor presentation 208 patients had been evaluated in trials with PRO140. The latest June 1 PR stated: "To date, PRO 140 has been evaluated in more than 300 HIV patients in various studies."
Anyone interested in the information and facts regarding the trials, the following link may be helpful:
https://aidsinfo.nih.gov/drugs/423/pro-140/0/patient
As always Saltz, your insight is much appreciated. Best to all, patience is a virtue that many investors simply do not possess. Those who do will reap the rewards.
Thank you, and done.
HEALTH CARE
Wednesday 10th of May 2017 06:35:20 PM
Gilead Sciences Inc. — whose HIV-fighting drugs have helped to nearly triple the lives of people with the HIV virus and reduce the number of pills patients pop from 25 to one — expects this fall to ask government regulators to approve its final chronic HIV treatment.
But that's not the end of the Foster City-based company's journey with HIV patients, the company said. Instead, it will focus on drugs that act longer and, potentially, purge the AIDS virus.
Gilead (NASDAQ: GILD), which developed drugs like two-in-one, once-a-day Truvada and three-in-one Atripla, by the middle of the year expects data from a late-stage clinical trial of a drug called bictegravir. It could be added to a next-generation, Gilead-developed drug regimen called TAF, or tenofovir alafenamide.
The beauty of bictegravir, Gilead Chief Operating Officer Kevin Young said, is that bictegravir is designed to be kinder and gentler on HIV patients' bones and kidneys. That is important because HIV drugs by Gilead and others have increased the life expectancy of a 20 year old with HIV from 19 additional years to 53 more years, but researchers have found that HIV's wear and tear accelerates the aging of some organs.
"We believe this has the best of all worlds in terms of suppressing the virus and caring for the patient on a long-term basis," Young said Wednesday at Gilead's annual shareholder meeting.
If the bictegravir data are positive, Young said, the company will ask the Food and Drug Administration and European regulators in the third quarter to approve bictegravir.
Then that's it — no more chronic HIV drugs from Gilead.
Sort of.
Instead, 9,000-employee Gilead plans to turn its HIV focus toward longer-acting formulations. Much like it helped decrease the number of pills an HIV patient must take to one a day, Young said, Gilead could zero in on injections that would need to be taken monthly, quarterly or even longer between shots.
"It's more convenient than a daily pill," Young said.
Yet Gilead's HIV franchise isn't the biggest concern of Wall Street analysts and some the company's shareholders. Instead, they want the company to acquire drugs or companies with the more than $30 billion that Gilead has in the bank.
Gilead, led by Executive Chairman John Martin and President and CEO John Milligan, has that cash largely due to its HIV treatments and its hepatitis C drugs, which have effectively cured millions of people with the virus that causes liver cancer and leads to liver transplants.
Gilead's hepatitis C drugs — Sovaldi, Harvoni, Epclusa and Vemlidy — brought in nearly $34 billion over the past two years. A fourth drug, for people who have failed all other treatments, could be approved by the FDA by Aug. 8.
But by discharging the hepatitis C virus in as little as eight weeks, Gilead has created a world where its drugs aren't needed as much anymore.
"As you cure people, they move out of the health-care setting (for hepatitis C)," Young said.
Along the way, 30-year-old Gilead has charged wholesale prices as high as $1,000 a pill for Sovaldi and Harvoni, until discounts, rebates and competition changed what Gilead actually netted.
Gilead's overall net sales, which reached $32.15 billion in 2015 have been projected by Chief Financial Officer Robin Washington this year to be in the range of $22.5 billion to $24.5 billion.
While Gilead will acquire or partner with companies selectively, Young said, it will focus on tie-ups that have long-term opportunities and are "based on really good science."
As it is, Young said, the company is spending more on research and development in inflammatory diseases, such as rheumatoid arthritis, Crohn's disease and ulcerative colitis, representing 20 percent of the company's $3.1 billion to $3.4 billion R&D spend this year. Just two years ago, inflammation was 8 percent of $2.8 billion in R&D spending.
Its liver disease focus, meanwhile has shifted from hepatitis C to nonalcoholic steatohepatitis, or NASH. It specifically is focusing on a small group of patients — about 3 million of 12 million overall NASH patients — with an advanced form of the disease in which the liver is stiff from scarring and has difficulty functioning properly.
"It's a high-need population," Young said, and one that insurers will pay to cover.
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Godspeed 5Top. Your contributions have been much appreciated. Wish you the best of luck in your future endeavors.
You should be ashamed. For the very few, myself included, who have given you the dignity of even acknowledging your rants and wild speculation, this is a new low, even for you. What crystal ball gave you today's info Pears? You have shown your true colors shorty. May the last shovel load of dirt be as painful as the first. Good luck and farewell.
One thing is for certain, Anthony was put in his position at that specific time for a very specific reason. He is an operational guy, nuts and bolts, and most importantly, timeline oriented. If you look at the slides from the most recent presentation, the "golden quarter " that was mentioned was simply moved to Q2. There is no debate that Nader made promises outside of his control, but his belief was genuine and that mistake will not be allowed again . The first thing Anthony began working on was an achievable schedule, which has been updated. I can assure you all that hitting or exceeding all future timelines is the number one priority. The science will speak for itself.