Happy to hear it. Think of all those who lost their battles with these diseases in years past. Definitely changing times with all they now know about the human genome. It is truly wonderful. We have a great delivery platform. Be patient because WE'RE NEXT!
Gilead Sciences tops forecasts in 1Q as sales of newest hepatitis C drug Harvoni total $3.58B
Been seeing tons of commercials for Harvoni. Looks like it is paying off. Remember, things are never as good as they seem but never as bad as they seem. This analogy applies to sports and to life itself. You are never as good as you think or as bad as you think. The reality lies somewhere in the middle. TO THE FUTURE LEADER IN HEP B! Go longs...!
Below is a quote from the Catalyst website. So this #$%$ about Jacobus being so compassionate and Catalyst being so evil is horse sheeeyat. They are both being administered for "compassionate use". Also, companies get reimbursed for making the product available through compassionate use programs so the idea that it is given away for free (and the company is bearing the cost) is more sheeeyat. What people don't "get" is that it is not an approved treatment for LEMS so it is not covered by insurance. Once it has FDA approval, insurance will have to cover the cost for ALL LEMS patients, not just for LEMS patients that can navigate/figure out how to order the compounded versions of DAP. Who cares what insurance companies have to pay anyways? They are just evil and greedy too! ;)
Quote from Catalyst website:
"In the meantime, Catalyst is making Firdapse™ available on a compassionate use basis while it seeks FDA approval. (See the Firdapse™ Expanded Access Program)
In the United States, other approaches being utilized to manage the symptoms of LEMS include:
Infusion of intravenous immunoglobulin, ( IVIG ), a process through which patients receive 1-2 infusion sessions initially, followed by maintenance infusion sessions approximately every 3 to 4 weeks.
Compounding pharmacies may produce capsules or tablets with amifampridine, or 3,4-DAP, which is a free-base formulation. Patients with LEMS may be able to get access to 3,4-DAP through open-label investigational new drug studies at some large academic institutions.
Other approaches for treating the symptoms of LEMS patients include: plasmapheresis, corticosteroids, cyclosporine, azothioprine, cholinesterase inhibitors (e.g., pyridostigmine), and aminopyridines."
Ah yes, has caused an explosive move to the upside today. I quite frankly don't even know why this is newsworthy. The financial co.'s always have an ulterior motive for putting out information, that is, to get the lemmings to all march in the same direction. It's painful watching this sideways movement. Erck needs to get off the john. BOOORING...
Hey, I marked the post you posted below. Looks like you we got some catching up to do. Hint, hint, wink, wink...
ARWR will be $15 before april 30th
by juniorlevelbroker7896•Mar 10, 2015 1:26 AMFlag
mark this post fellas!
I am not a scientist or a chemist, nor do I play one on TV. Is it just me or doesn't the protocol they are employing seem deeply flawed? You are going to take patients already on Jacobus' DAP for 3 months and ween them off to a placebo? The criteria is that you must "be willing to chance being tapered off 3-4-DAP"? Huh? So you're taking medication and controlling symptoms. Now you get the placebo because you are in the weened group. I'm going to finish the study and lose my mobility? Maybe when I lose my mobility, I am going to pop some of my DAP stash (that I know works) so that I feel better and can function or maybe dropout all together. Seems like a bass-ackwords approach. JMHO.
"In this expanded phase 2 trial, participants will be randomly assigned to continue their usual dosage of 3,4-DAP or to gradually reduce (taper) their 3,4-DAP down to zero (a placebo). Neither the investigators nor the participants will know who is taking their usual dose and who is in the "taper to placebo" group until the trial has been completed.
Each participant will be screened and then, if considered eligible for the trial, asked to spend up to a week in a clinical research center.
Participants will take "timed up and go" functional tests, which measure how long it takes for someone to move from a sitting to a standing position and then walk a short distance; they also will report their own assessment of LEMS-related weakness.
•be ambulatory (able to walk) while taking 3,4-DAP (i.e., can perform the timed up and go test, either with or without an assistive device);
•have an established diagnosis of LEMS, with documentation provided;
•have been taking Jacobus' 3,4-DAP for at least three months;
•have been taking a minimum of three doses of 3,4-DAP per day, with no single dose being less than 10 milligrams;
•have been on a stable regimen of all LEMS-related treatments for at least three months;
•be willing to chance being tapered off 3,4-DAP
AF releases his hatchet job @ 12:05PM on Friday 04-24-15.
Look at what else was going on at that exact time. From the Catalyst Press release:
"The oral presentation titled, "Amifampridine phosphate (Firdapse) is safe and effective in a pivotal Phase 3 trial in LEMS patients" will be given during the Clinical Trials Plenary Session on Friday, April 24, 12:00 pm-1:30 pm. This session was designed by the AAN to address important clinical topics identified throughout the neurology community that affect patient care, and the Science Committee considered the Firdapse Trial results an advancement in the field of autoimmune disease and neuroscience.
"LEMS is a very rare autoimmune disorder with debilitating muscle weakness and other severe symptoms," stated Dr. Shin Oh, Distinguished Professor Emeritus at the University of Alabama-Birmingham and invited presenter at the AAN conference. "The statistically significant and clinically relevant outcomes of primary and secondary endpoints of the Firdapse® pivotal Phase 3 trial demonstrate the potential for Firdapse to help patients with this severely disabling disease."
"We are pleased that Dr. Oh has been invited to the AAN conference to present the data from our successful Phase 3 Firdapse trial to an audience of neuromuscular disease specialists and neurologists," stated Patrick J. McEnany, President and CEO of Catalyst. "I would like to once again thank all the patients and physicians who participated in this Phase 3 trial as we continue to work towards the approval of Firdapse."
The CEO "answered" AF. He bought 5000 more shares since the AF hatchet job was released.
Catalyst CEO just HAD TO add 5000 more shares to his 4.1 million share holdings today (at these AF fire sale prices). I am stickin' with the guy with pocket Aces...
From 2012 Inspection:
"The current inspection was a comprehensive cGMP inspection providing coverage to the Quality, Facilities and Equipment, Production, and Laboratory Control Systems. The inspection revealed the following deficiencies: the failure to adequately perform failure investigations, inadequate cleaning of manufacturing equipment, the failure to perform temperature mapping studies for a cold-storage warehouse, the failure to maintain facilities in a state of repair, and the failure to maintain manufacturing equipment in a state of repair, the lack of manufacturing instructions and control procedures for a redacted (B) (4) step, the failure to label containers, the failure to validate a stability indicating test method, and the failure to validate a supplier 's certificate of analysis. An FDA-483, Inspectional Observations, was issued at the close of the inspection to Dr. David P. Jacobus, President who promised a written response to the District within 15 days. Prior to the issuance of the FDA-483, Inspection Observations, I informed the firm ' s management that the firm ' s response may impact FDA's determination of the need for follow-up action, if FDA receives an adequate response to the FDA-483 within 15 business days of the end date of the inspection."
Just tell me when to stop. We lost 25% market value FOR THIS? From the FDA Review of Jacobus:
Re: 2011 Inspection:
“The previous inspection conducted in 2/2011 was a comprehensive cGMP inspection providing coverage to the Quality, Production, Laboratory Control, Materials, -Facilities and Equipment; and Packaging and Labeling Systems. The previous inspection revealed the following deficiencies: the lack of a stability indicating test method for Dapsone tablets, the failure to perform impurity testing of Dapsone drug substance on stability, the failure to perform investigations into temperature excursions and the failure to perform investigations according to procedures, the failure to review all complaints and investigations during annual product reviews, the lack of controls over the data acquisition system, the failure to maintain the sampling suite in a state of repair, the failure to calibrate instruments, an inadequate process validation following a scale-up, the failure to take representative water samples , and the failure to identify containers in a manner to prevent mix-ups. The previous inspection was classified V AI.”
Just G0ogle "jacobus pharmaceutical FDA violations". Open the first link. It is a PDF file. Give it a good read and then think about what you have in this opportunity with Catalyst. Make your own decisions and come to your own conclusions based on what you read. You can then decide for yourself if this is a good place to exit your position, hold your investment or load up on your position. I know where I stand!
Checkout AGEN's move this past friday. Was all based on GSK's positive results for a malaria vaccine. Uses AGEN's adjuvant (QS-21). Was up nearly 12% on Friday and was up as much as 15% during the trading day. Yes, these nice "little" additional assets can be very lucrative indeed.
All I can say is bad for patients, good for us.