And you do have proof of what you say? It would be nice to have you list the proof, instead of having to take your word for it.
I will say that a large clinic type environment would be a better then the one I had imagined (a machine in the local urologists office). So, lets speculate. DNDN should have centers (not that they own them, but this is a model), where the patients comes in, gets the apheresis performed. The patient would stay in a hotel like setting (if too far away from home). The process of making provenge will still take 36-40 hours, but there will be no requirement to use courier services (so that savings along would pay for a two day hotel stay). When ready, the patient comes in and the infusion takes place. When all the t's crossed and i's dotted, patient is sent home. They will come back in two weeks. No capital outlay by DNDN for a "plant" would be quite a savings. If these sites were co-located next to tourist oriented parks would give the patient something to do while waiting for the product to be made. But, in order to get there from here, we will need to survive what we currently have.
I do not think the the automation effort will be "onsite". Do you have any evidence of this? What is very importance is the cleanliness of the process. The reason is that the product base (the patients cells) cannot be sterilized, they can come with whatever is possible for a human to have, disease wise. I will wait for your reply.
I don't need to look it up, I believe you. I watched the same stuff you did, and if I fault DNDN for the path they took, they didn't realize that their competition wanted to kill them off. They failed to defend their product and let people with agendas (think Huber) say and print what they wanted. GLTU Sir
The parameters of the trial were originally worked out between DNDN and the FDA. For whatever the reason, distant mets was one of them. (I think DNDN wanted a quicker trial so they picked parameters that would net them sicker patients, but only my opinion). Once approved, FDA/CMS wanted to be sure of it (probably to restrict the number of patients) so restrictions remain.
There is one thing for sure. That your Doc should keep testing for progression. One problem is that if a watchful waiting is used, your father will slip through the cracks and not be able to get provenge if the mets got to liver/brain (you should check that).
GLTU and your Dad.
11. no pipeline drugs anywhere close to approval.
neuvenge in phase II, small cell trpm08 in phase I
combo trials with zytiga, xtandi,
12. barely $100M cash and $100M plant assets by end of June (liquidation value much less)
399M in assets from last 10-q
13. a fat CEO who fails to keep promises to shareholders
I will not argue to his weight, but he has failed to address with us his plans for debt
14. JPM unable for the past 2 quarters to place a secondary and raise capital to restructure debt
and how do you know this?
15. shorts have maintained control of this stock since Johnson left SVNT to become CEO here
yes, it is called manipulation and I think it is illegal
1. no sales growth since December 2011 when sales peaked at $85M
there was a yoy increase this last qtr compared to one year ago
2. crushing $647M debt, of which $28M is due within weeks
the 26M will be paid using current cash, the remaining will have to be addressed
3. two stronger competitors with rapidly expanding foreign sales
provenge is indicated prior to either (with zytiga not being approved pre-chemo in UK
4. xtandi set to gain U.S. pre-chemo approval in only 4-months
even in US, provenge is indicated for first use
5. ongoing losses despite closing 1 plant and several layoffs
poor choice by management (previous and current) not to act sooner on excessive fixed costs
6. poor manufacturing process that guarantees no possibility of profits
totally BS. My earlier analysis showed that with full capacity, 25-30% COGS was possible
7. no big pharma partners willing to invest in provenge for EU
don't really know, but JJ said that the terms being asked were not favorable
8. no possibility of ever paying off remaining $620M debt due in 2016 from profits
well, you have to have profits, and increasing sales and decreasing will see profits
9. still do not have automation plan approved by fda
automation will only help if a) you cut back on current production methods (to save on labor)
or b) to fill any production shortfalls if current capacity exceeded
10. no technology license revenues (IP is worthless to big pharma)
the cassette interface has shown to be an effective way to provide immune awareness to the
T-cells for a variety of antigens
cont on next page
Provenge has a website and you can check there and a toll free number. Has your urologist ever prescribed provenge?
"both are blowning away provenge"
Maybe you have spent too much time on all fours blowning the competition. When one looks at the cancer guidelines, provenge should be given first. And in the UK, the 13 month survival figure is allowed in the marketing literature. And, recently, Reuters reported this:
"Reuters) - Britain's healthcare cost-effectiveness agency NICE said on Wednesday that a Johnson & Johnson prostate cancer drug, originally invented in Britain, was not worth giving to patients who have yet to receive chemotherapy.
Although Zytiga, or abiraterone, is already cleared for use in some men after chemotherapy, a green light for its earlier use would allow many more patients to access the oral medicine.
"We know how important it is for patients to have the option to delay chemotherapy and its associated side effects, so we are disappointed not to be able to recommend abiraterone for use in this way," Andrew Dillon, chief executive of the National Institute for Health and Care Excellence (NICE), said in a statement.
"However, the manufacturer’s own economic model showed that the drug would not be cost-effective at this stage – because of this we cannot recommend the drug in this preliminary guidance."
The Xtandi had a medium life extension of 4.5 month. Provenge, when the PSA is less than 22 ng/ml has a life extension of 13 months (as is allowed in the EU). If NICE is basing it decisions on how well the product works, seems like Provenge is better, wouldn't you say?