is any one familiar with patent laws as they apply to Concert pharma's changing one molecule of kalydeco and claiming it is a better drug and implying they could market that drug if it passes phase 3 successfully?
It sounds to me like someone taking an Apple IPhone, make a little modification and try to sell as a better or similar product. VRTX has not addressed the issue of what Concert is doing even though Concert announced a while ago that they were planning to do this.
Any patent lawyers out there who can help us understand the issue involved or has anyone called VRTX to see what they say about Concert's undertaking?
VRTX sp performance during the last month compared to other big biotech's indicates indeed that "the market" is expecting major negative information, Clintons initiative certainly can not explain the steep decline in sp, VRTX is not affected by reduction on patent extensions for biologics, let's see what next cc will bring
And by the way Gladpick - Here are the real numbers.
20 posts | Last Activity: 56 seconds ago
Member since: Jan 19, 2015
Sentiment: Strong Sell
Don't be ridiculous. Stop trying to discredit me and try and discredit the actual posts from all the CF patients about Orkambi. Have someone add you to a site. You may want to factor it in. If you already did then good for you. But its all out there. Its not pretty.
Sentiment: Strong Sell
"I have been following Vrtx for 14 years" and you have not had a single post on this board for 14 years until today?
Here is the number of posts by longlivevrtx during the lifetime of Yahoo's VRTX message board--only 5 posts and apparently they started today!
[containing “longlivevrtx”: 5 results]
Our DD has been on Orkambi for 75 days, the only initial side affects were some chest tightening and a few days of increased mucus production. This is the longest she's gone without antibiotics in 3 years.
Qdelfan - As I say above, I was simply saying is that now that Orkambi is main stream out in the field, early patient reports are very concerning and for me, I am concerned on sustained revenues.
Gladpick - Well you are wrong on all 3 of your statements. Of course I have a CF child and if you look thru history of this board you will indeed see posts from me supporting Vrtx. My posts are not bad mouthing Vertex. My posts are sharing information that many many many CF patients are having a very tough time on Orkambi since starting 6-8 weeks ago. If you do not have a CF child, you likely do not have access to that information like the rest of is CF parents/patients do because those FB sites are private for patients. I have been following Vrtx for 14 years and f course have read all the studies. What I was simply saying is that now that Orkambi is main stream out in the field, early patient reports are very concerning.
Sentiment: Strong Sell
fer01mat - I hope your children are as well as can be. What I am saying, and you have pointed it out with your own kids, Orkambi's effect, if any, varies greatly. From a CFs point of view, you are correct, anything is better than nothing. However from an investor point of view, I am saying that, in comparisons to many other investments, there is higher than normal risk exposure for investors who may be counting on sustained future revenues from Orkambi. The patient drop out figure will be much higher due to either patient stopping treatment due to ill effects or insurers stopping payment due to no clear evidence in some patients of some positive effects. If I was an insurer, I might say I am glad your child has coughed up gunk but if thats the only measurable benefit than there is likely cheaper mucolytics or expectorants that don't cost $259,000. I am not going to debate Orkambi effectiveness, all I am saying is from an investment point of view, these risks simply need to be discounted into the future revenue projections when determining stocks value. Good luck to your kids.
Sentiment: Strong Sell
Glad, tt does seem odd he does not acknowledge the benefits proven in Transport and Traffic, the Phase 3 trials that produced statistically significant benefit in over 1000 patients after just 6 months of treatment with Orkambi meeting primary endpoint goals and allowing FDA approval. Only a 4.2% dropout rate was reported in these Phase 3 trials, and on completion of Transport and Traffic, over 1000 patients (greater than 90% of those enrolled in the phase 3 trials) voluntarily have continued in the rollover study including the patients previously on placebo during the Phase 3 trials whose improvements after starting Orkambi in the open label rollover again duplicated the results of the treatment group at 6 months and all patients have had sustained benefit for the past 2 years. Certainly the first few weeks of treatment can be challenging for some of the 508dd patients starting Orkambi, but the pay off after just 6 months is already proven, so renewal of medication for the majority of patients started on Orkambi should not be a problem for the great majority of patients.
My youngest began to cough up junk 12 hours after her first dose. She never gets stuff up in the morning. It was different that morning. Her fev improved by 4 or 5 points after being on 1 month. Not sure what you're arguing here. Are you saying Orkambi doesn't work? I disagree. My children both experienced chest tightness and fever the first week or so, but that was it. Everyone is different, even my two children. One has fev below 40 and the other has fev above 80. Something is better than nothing. I look forward to the results from the 661 combo studies and all the other medicines coming along. My outlook is hopeful and in my mind the good outweighs the bad as far as VRTX as a company goes.
He pretends he is the father of a CF child, yet hates VRTX--a company that has put just about ALL of its resources to develop improved drugs for CF patients. Any CF parent who truly loves his/her child is lucky that VRTX is doing all it can for their child. I suspect longlivevrtx is a short pretending he has a CF child. He never posted here before and all of a sudden he has multiple posts badmouthing VRTX.
Longlivevrtx, one last thought. I hope you child can benefit from these new CFTR modulators. If insurers are giving your health care provider a hard time in starting Orkambi, VRTX is assisting patients and health care providers in getting the necessary authorizations from the insurers. Whatever coure of treatment you choose, I wish you and your child well in battling this disease.
You just hit on the issue. It required 2 years. As a CF parent of a dd508 child, I would like nothing more than for Orkambi to work for my daughter. However when you look at reports from the patients reporting privately, their first 2 months are a nightmare of side effects with PFTs drops, causing many to require hospitalization or IVs. My daughter included and she falls into the higher 80% FEV range. These take a while to resolve so when many get to 6 months renewal for insurance, they will not meet the criteria above as hospitalizations and infections occurred since Orkambi, QOS wont make it yet and weight gain is unlikely while fighting infections. Orkambi is not Kalydeco. Kaleydeco had hard measurable increase in Fev1 within days/weeks. True cause/effect obvious. Orkambi - its a very soft cause/effect that takes 2 years and endpoints are very soft.
As a CF parent, you are certainly aware that PFT's deteriorate on 2% yearly average, even with all the palliative CF treatments currently approved before Orkambi . The lumacaftor/ivacafator rollover study has demonstrated durable stability in PFTs and decreased incidence of hospitalization and infection weight gain and reported quality of life assessments compared to being on existing treatments alone two years after initiating treatment. Just one of these criteria needs to be reported to allow renewal of Orkambi at 6 months under Medicaid guidelines issued in the first week of August this year. BTW: CF patients have a legal precedent in demanding insurers to give necessary treatment after the court case in Arkansas challenging that state's medicaid denial of Ivacaftor to qualified CF patients. Those patients are now receiving Kalydeco under their Medicaid insurance and the state had to pay the legal costs for the plaintiff's victory in this case.