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AMRN, RON- i did listened to both CC same day. they were just great as you said. this board is full of good thought leaders , so i wanted to make sure i put up my doubts. thanks for the reply. BFR and sheff also gave great explanations of the thing. I am long AMRN and will stay with it untill it get bought out.
AMRN: can any body tell this was an automatic sell or something else.
Long and strong PLX!
PLx- secondery news is old. i brought it up with sheff before pudfa and we discussed about it. it doesn't matter. some moronic short want to bring this down and scare people off IMO!, near term there are few catalyst_ europe april pudfa, very high chances of approval, the ceo said that , they submitted cross over study data to europe as they asked it, but they did not gave it to fda becuase smart people at FDA did not asked that data and fda application was submitted beofore EU! talk with brazil going on for long term contract. PFIZER is helping them to resubmitt stuff to FDA.
PLX, Taxi cat- Honestly, people who are saying one year for filing , i don,t know they are using there head or not! my best guess is they file with in 2-4 months and get class one or class 2 resubmission. there is 50 50 chances of class one and class 2 resubmission. that should take us any where between 5 months best case scenario and 11 months worst case scenario. during cc ceo said that we will try our best to do it as fast as possible. april europe approval should come, brazil tallks are already going on with brazil ministry of health. if some body has patience of couple of months , it should trade high eight or low nine. i may be totally wrong. this is my best guess
PLX presentation @ citi.
CEO clearly said three specific things
1. FDA is not at all concerned about safety and because of this reason FDA is allowing commpassionate use in US.
2. no new trial is required.
3. will try to make this process of FDA approval as fast as possible.
http://phx.corporate-ir.net/phoenix.zhtml?c=101161&p=irol-EventDetails&EventId=3772256
WARREN BUFFET'S ANNUAL LETTER, A MUST READ!
http://www.berkshirehathaway.com/letters/2010ltr.pdf
"PEOPLE WHO SAY MONEY CAN NOT BUY HAPPINESS DON'T KNOW WHERE TO SHOP."
Investor 100: it,s a great company. i still have 60 % plx left to sell @ >8
PLX: i agree. FDA dropped the ball not PLX
PLX: sold 40 % @ avg of 7.25. rest will keep for a ride above 8
PLX HOD 7.16. Showing amazing strenght after CRL. Market expects them to do well with FDA and of course with EU
Agree investor 100. CC was much better than expected.
Agree, soft ball
Taxi cat great plan, already close to 7. i think your plan is great. unfortunately i dont have money to double down. sold some at 7 in the morning. showing good strenght
Thanks for all you do, keep it up. As u said mid to long term story is still very favorable.
I was listening to CC. management has all the data already, they need to compile it and hand to the fda. pfizer has said that they will be proactive with all the technical and regulatory help. my assumption is 3-5 months with class I resubmission.
I think with FDA being "bureaucratic bunch of pygnmies" your plan is right
AMRN: i dont think so , they still have lots of options and shares remaining. i think it's routine to sell some for personal expenses etc. No worries!
AMRN sec filing ZAKRZEWSKI JOSEPH S
http://files.shareholder.com/downloads/AMRN/1053624814x0xS1181431-11-12895/897448/1181431-11-12895.pdf
PLX happy countdown 13 hr and 10 min left
with this 10 k timing, my guess is tomorrow morning should be approval!
DCTH: i was big believer in it. this instance has definately shaken my confidence a bit. i would not enter in to it untill they release phase III publication and phase II data. No more greed!
Sheff nice new symbol of yours, like it!
PLX 10 k important info:
In addition to taliglucerase alfa, we are developing an innovative product pipeline using our ProCellEx protein expression system. Our product pipeline currently includes, among other candidates, (1) PRX-102, a therapeutic protein candidate for the treatment of Fabry disease, a rare, genetic lysosomal disorder in humans, (2) PRX-105, a plant cell expressed pegylated recombinant acetylcholinesterase product candidate for biodefense and other indications, (3) pr-antiTNF, a plant cell expressed recombinant fusion protein made from the soluble form of the human TNF receptor (TNFR) and an antibody portion, which is being developed as a treatment of certain immune diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing, spondylitis, psoriatic arthritis and plaque psoriasis, (4) an orally administrated glucocerebrosidase enzyme for treating Gaucher patients utilizing the oral delivery of the recombinant enzyme produced within carrot cells and (5) additional undisclosed therapeutic proteins, all of which are currently being evaluated in animal studies. In March 2010, we initiated a preliminary phase I clinical trial of PRX-105 which we completed in June 2010. We are currently preparing for further efficacy trials of this product candidate in larger animals. In our preclinical studies we utilized an analogue to nerve gas. However, we anticipate that we will use live nerve gas rather than an analogue in the proposed additional efficacy trials in animals.
Our ProCellEx protein expression system is built on flexible custom-designed bioreactors made of polyethylene and optimized for the development of complex proteins in plant cell cultures. These bioreactors entail low initial capital investment, are rapidly scalable at a low cost and require less hands-on maintenance between cycles, compared to the highly complex, expensive, stainless steel bioreactors typically used in mammalian cell-based production systems. As a result, through our ProCellEx protein expression system, we believe that we can develop recombinant therapeutic proteins yielding substantial cost advantages, accelerated development and other competitive benefits as compared to mammalian cell-based protein expression systems.
Our goal is to become a leading fully integrated biopharmaceutical company focused on the development and commercialization of proprietary and biosimilar or generic versions of recombinant therapeutic proteins. To that end, we are leveraging our ProCellEx protein expression system to develop a pipeline of proprietary and biosimilar versions of recombinant therapeutic proteins. In addition to the product candidates that we are developing internally, we have entered into agreements for additional compounds with academic institutions, including a licensing agreement with the technology transfer arm of Israel’s Weizmann Institute of Science and an agreement with the technology transfer arm of the Hebrew University of Jerusalem. In addition, we are collaborating with other pharmaceutical companies to develop therapeutic proteins that can benefit from the significant cost, intellectual property and other competitive advantages of our ProCellEx protein expression system. We entered into an agreement with Teva Pharmaceutical Industries Ltd., or Teva, in September 2006
5
plx in talks with the the brazil for long term supply from their 10K
http://www.twitlonger.com/show/8vs2qf
PLX HOD 9.64
PLX: Impossible to tell , at what time day approval will come. WITH FDA , everything is just guess, approval can come tomorrow also. But with the DD this board provides, i can tell u that, chances of approval are very high.
PLX printing 10 AH on very low volume (ONLY 300) any leak?
PLX, DCTH: Sold dcth@ 7.20 . will re enter again after few days once dust settles. doubled down on PLX. WAs very surprising. never thought of that refusal letter from fda. Nothing is certain with FDA. lesson learned! still like the long term story for dcth.
AVNR 3.63 wow!!!
PLX, going down in sympathy with DCTH excellent opportunity , so close to PUDFA.
DCTH: definately, short term set back for DCTH and it's holders. will do very well in mid term. No worries. Longs , who will embrace the volatality of this stock will do very well IMO. excellent opportunity to load up more.
Sheff, Superb achievement. Keep it up. May god bless u!
DCTH: this is called short sqeez, just the start.
DCTH (received ISO 13485 this morning): Understanding ISO 13485, the below article is educational for those interested in understading ISO 13485, those who are not interested in understading the ISO 13485 may ignore it.
http://www.qualitymag.com/Articles/Feature_Article/BNP_GUID_9-5-2006_A_10000000000000225133
AMRN.... same here TAXI.[img][/img]
DCTH: you should do well, IMO if any short term pop happens , it will be next week and not this week. it is possible that pop can happen till friday, but chances are more for next week. they have presentation on sunday and PUDFA news should also happen next week , i think. best of luck, my largest holding so far after plx.