Cameron loves walking! He is even learning to kick a ball! He gets an injection this week in the clinical trial. He continues to impress us with his strength and we know the doctors will be as impressed when we see them this week. While we are there we are taking him to Sea World! Let's hope we all stay healthy!!!!!!!!
Looking forward to SMA drug approval. t
Juno Therapeutics receives notice from the FDA that a clinical hold has been placed on the Phase II clinical trial of JCAR015 (shares halted) (40.85 +0.88)
The co announced that it has received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold has been placed on the Phase II clinical trial of JCAR015 in adult patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL), known as the "ROCKET" trial. The clinical hold was initiated after two patient deaths last week, which followed the recent addition of fludarabine to the pre-conditioning regimen.
Juno has proposed to the FDA to continue the ROCKET trial using JCAR015 with cyclophosphamide pre-conditioning alone. In response, the FDA has requested that Juno submit, as a Complete Response to the Clinical Hold: a revised patient informed consent form, a revised investigator brochure, a revised trial protocol, and a copy of the presentation made to the agency yesterday. Juno will submit the requested information to the FDA this week.
Juno's trials and plans for its other CD19-directed CAR-T cell product candidates, including JCAR017, are not affected.
This type of "info" that you "release" here show's exactly how you have been exposed as a person with really no info. I believe that deep down you are afraid that IONS is going to make it really big and you have now gone on the war path against it. NO??? Everyone take a look at your "timely" post about what type of tough straights BIIB is in and how terrible they are going to do and how bad their MS drugs are doing and then go look up their share price today to see UP OVER $50 today. You might want to look at your own shoes before you lecture someone about deep doo doo. And people here can thank you for the "tip" on BIIB. t
Check again SFB's and maybe put up the last quote for each company in regards to share price. I myself wouldn't brag about a one day movement as the market is complicated and many things go on over a day's worth of trading. It is really the intermediate and long term that matters. But since you are a SFB's that brought up the issue....why don't you put out the closing price of each stock? Frankly if I had recommended a stock that took a reverse stock split of 10:1 I'd never show my face here again, or at least not brag....but you're a different kind of animal. t
Again an exaggeration by you and you are fixated on old news. And please pull up the link to back up your delusion. Why don't you go after that oil analysts at Goldman Sachs that four years ago said oil was going to $200 per barrel? You have no ability to think in the abstract. Skybuster00, carry on captain!!t
WOW you really wigged out......no sound arguments. You need to change your name to skybuster00 to reflect your true knowledge!!!! t
Also, why don't you tell the full story. 75% of GILD success has occurred over the last two years with their blockbuster HepC drugs. They however have really strained the medical system with that huge price to be paid for so many people who have Hep C. The other real truths are that the drug was priced so high that they have been forced to discount it to the VA and other insurances companies. The other disgusting thing about that was that if you live in India you can get full treatment with their Hep C drug for $900.......how about maybe pointing that out??? Also, the market isn't too impressed about GILD lately. That being that there are questions about their being able to keep that monetary projection into the future with new products....how about pointing that out?? Also, ARIA, IDRA, VRTX, EXEL and many others started at the same time or around the same time as IONS did. How about pointing that out? How about a comparison of IDRA with IONS in regards to: cash on hand, deals with big pharma, pipeline etc??? I would rather take my chances with a company that hasn't had their value fully reflected than to go with GILD. Though GILD is not a bad investment here. The main question is, do they have the potential that IONS has over the next three years? I say NO. Especially when my genius from skybuster gets over to their website and the company and scorches them for their extremely high prices and price differentials between countries for the Hep C drugs, their lack of diversity of pipeline making it where analysts are demanding they do something or buy something because of this fear. t
I'd immediately set out ot the GILD board and chastise them about the cost fo their medication and how you are afraid that we will run out of money with their charging orphan drug prices for a mainstream illness. t
You must be talking to Aaron Reames....wasn't my call. You seem to be getting weirder and weirder. Also hint at being...won't say on this screen but what you said about the SMN drug, the patient's, and the judgmental statement was somewhat frightening. Maybe you could call that Aaron guy and tutor him on how to be perfect. t
Why don't you write up your speech and present it the AWRW board where millions have HepC and the price of the drug will probably like the ones are now.....that being orphan drug pricing for a main stream disease. t
Ten cent, I think those numbers that you noted could very well be representative what we will see from this med. I just get the feeling that the EU will approve this message before we see the FDA here do it. t
Man you need to go to the ARWR board and lecture them about HepC and the cost and all that you've done here. t
Again you don't understand medicine. It will be cost effective to treat these babies with a medication that can greatly decrease their need for hospitalization. A two week hospital stay on a ventilator will be more expensive that a year's cost of his medication. Why don't you make about 100K enemies and tell your great knowledge to the FAST organization. t
The guy doesn't understand medicine....If he had a child with that disease he'd learn quickly. But for now to try and make a worse argument toward IONS he resorts to that. t
Bad arguments so you question my being here? How about you moving over to the ARWR board permanently?? t
I addressed your points/arguments and that is the kind of response I get?!?! Many inaccuracies in your "report" so the Hugo Chavez type of argument comes out. t
One final thing. Take a look at the RNAi companies. When they first came out people were saying that they were going to have products on the market in a few years. That was 15 years ago. The closest RNAi drug that will be able to come out will be in at least 2017 that being from ALNY.....that despite standing on the shoulders of a company like IONS. If their first drug fails....which I believe is highly likely it will be another 12 to 18 months before they will be able to get a drug approved. The CEO has a teflon coating. He noted that their ApoB 100 drug was extremely effective...and it was. Problem was that the monkeys became very sick and had extremely high liver enzyme levels. Now their latest Gal-Nac versions may not be as toxic. But in their previous use of their technology in the eye for eye diseases the patients actually did much worse than placebo. Couple that with the fact that he promised 3 $billion dollar deals one year when they had signed all of their non-exclusive deals with big pharma and not one of those deals came to frution. You want to talk about big pharma paying out big dollars and seeing nothing from their investment ask: MRK, NVS, Takeda, and others what they received for their huge payments to ALNY? The glass is half empty or half full....but with IONS unique drugs, huge research base, and unique products the facet will be running. t
If you are update in regards to the 2.0+ generation and you could find the ability to look at things objectively you would find that the ISR's and flu-like symptoms are all but gone with the that newer generation of drugs. A huge conjecture on your part saying that the patents with ALNY were unenforceable.....are you a patent attorney? Do you have links to make your arguments? IONS IMO was extremely generous to ALNY, you don't really know the true story about RGLS. IONS let ALNY into RGLS because there were two patents that RGLS might violate over into ALNY's territory. So for ALNY putting in an extra $10 million for RGLS being able to use those patents they were allowed into RGLS. ALNY made a ton off of their investment. The problems that RGLS is having isn't IONS problems. First off the Gal-Nac system being used is ALNY's, secondly they are completely different technologies. The extremely long-half life that the RGLS product had in the cytoplasm may be THEIR problem. I believe that you fear that IONS is really going to do well and that is why the sudden outburst. If they fail you can really rub my nose in it. Let's see, and let's see how your biotech picks do.....I do respect the fact that you did in fact put out some picks there. t
You have really a skewed report here. IF Dr. Crooke said that Mipo wold replace statins he quickly reversed territory once he realized what was transpiring in regards to data coming in from statins and the price disadvantage. I myself and many others sat in on the annual meeting over eight years ago where he adamantly noted that Mipo would NEVER replace statins but that it was hoped that patient's that failed on statins would be able to benefit from Mipo. As far as Vitorvene the technology for treating HIV surpassed the drugs use as more effective HIV treatments were developed and there wasn't the same risks of coming down with CMV retinitis. It is too early to say whether or not ANS drugs could replace Mab's but in looking at real reality it took over 20 years for Mab's to become mainstream in medicine. Even with that true fact Mab's aren't the end-all treatments for many diseases. Your patent argument makes no sense. Their is nothing in regards to almost all of those companies you mentioned. ALNY is the Rottweiler of lawsuits for RNAi companies, many of which you mentioned. No ANS, RNAi....also the MRK situation had nothing to do with IONS dropping the ball, it relates to "unclean hands" that MRK person did and allowed to have the ball dropped. Not including this info is again giving a partial truth. Also, tell the truth about the satellite companies. These are companies that IONS didn't want to assume the risk for their endeavors and thus they helped them out but they weren't/aren't part of the central portion of IONS. Tell the truth, the T-5000 got IONS over $240 million dollars, the RGLS IPO and the selling buy IONS of millions of shares in the high teens and higher looks like a genius move on their part. They put in about $25 million at most and received well over $150 million in return and they still own some shares, though not nearly as much shares as they did thanks to LP selling those shares at a high share price.