This makes sense that once it was looked at that a lower dosing of Dacogen would lead to higher response rates, they would intiate a trial for survival with the Alt dosing. Manuso stated, months ago that the EORTC was fully accured, so these links probably are a second trial that is still ongoing. Maybe we get a update at some point about early results?
You maybe looking at a second survival study with low dosing. The first survival study is with the approved dosaging and it has reached accural, awhile ago. Look at each link and it clearly states low dosaging. This study maybe important later because lower dosaging could have additional data that suggests greater benefits. This is my take on these latest links.
BTW, at http://clinicaltrials.gov/ct/show/NCT00043134
it is stated that:
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), October 2007
If they were still recruiting participants for a two year study in October 2007 they won't have results until October 2009.
The dates are a little confusing:
First Published: 8/1/2002
Last Modified: 12/12/2006
Trial Start Date 2002-05-23
Date Submitted to PDQ 2002-06-12
Information Last Verified 2007-10-07
If the trial stared 2002-05-23 shouldn't it have finished by now?
Sorry, the correct acronymn is EORTC. As you can see from the link, all the trial sites are in EU.
As has been stated, EU Dacogen NDA will be based on the EROTC survival results. As I recall, JJ and EMEA had previously agreed that this will form the basis of the NDA application. If you look at the trial sites of EROTC, you will see various EU locations.
EU approval is NOT an issue until the EROTC results are available. As discussed, the EROTC Dacogen results should match closely the results of Vidaza.
On CNBC, the CELG CEO was interviewed and stated that the PHRM sales and distribution channels was one of the major factors in the decision to acquire PHRM. I take that to mean the sales staff would remain. Good salespeople are hard to find and are an asset to the acquiring company. The HQ and regional staff are the ones who will be downsized. I am praying that Dacogen will show some substantial benefits over Vidazza. The October Dacogen sales should tell us more on how this race will play out. PHRM had Aug-Oct to get the word out to MD's. If Vidazza sales are trailing Dacogen in October and SUPG has good news to present soon then this race will be won by SUPG/MGI. At this point I worry more about delay in obtaining EU approval.
The funds are setting up their books for year-end reporting.
Those that have realized capital gains are selling LVLT at a loss to offset their gains in onther stocks. They mark to market eveyday anyway so their total gain (or loss) for the year is not affected by whether they sell or hold LVLT. But their shareholders' taxable income is since only realized gains/losses are distributed.
It appears there is at least one large purchaser that is willing to buy in at $4.00 and is absorbing everything. It is possible that some of the large transactions are actually between funds managed by the same institution.