Some others failed and got pulled from the market, but there are five drugs (late stage) entering into an already saturated small AML market, less than $190 mil total in the US.
The AML market is relative small beacause standard of care hasn't changed in 30 years and the AML market is screaming for new drugs. According to SeekingAlpha is SNSS in the lead to bring a new drug to the market.
The global AML market is estimated to 900 million dollar. With no competition in sight SNSS can get a huge part of the AML market.
AML treatment-eligible patients(1):
– U.S. 22,000
– Europe 22,300
(1) Based on 2020 company projections; U.S. – Decision Resources AML Pharmacor Report 2006; EU – Datamonitor AML 2009.
CYCCs 30 day mortality is 10% and the company havent given us the 60 days mortality, probably because its to high. CYCC has some safety or tolerability issues here going forward.
Dont humiliate yourself toxic asset. Go back to the CYCC board, you are too toxic for this board.
The earlier, June press release shows:
preliminary median Leukemia free survival > 10.8 months
the above updated Nov. release shows:
preliminary median Leukemia free survival > 14.4 months.
When will we get next data update???
Preliminary Leukemia-free survival = time from complete remission (CR, CRp, or CRi) to relapse or death.
The deciding factor to approve AML is OS (Overall Survival-not mortality rate) rate, the primary endpoint for CYCC which FDA granted on, thus, SPA! For CYCC. Good for them!
CYCC will be approved-if no big negative surprise-through this approved FDA guidlines.
But CYCC's PPS does not want to go up higher even after the approval of the SPA by the FDA and do you know why?
AML market is seen much less attractive than most you penny traders were pumped to get deceived/perceived.
Too much competition, too little market.
Here's the data from CYCCs Phase 2 trial presented 15. February 2011:
Phase 2 AML Data (n=60)
Aged ≥ 70 years 80% untreated; 20% first relapse
–Randomized across 3 dosing schedules
–55% AML de novo; 45% AML preceded by AHD, such as MDS
Primary endpoint ASH 2009: 1-year survival = 30% *
Secondary endpoints: Overall Response Rate = 35% *
Median Overall Survival = 212 days (range 13-654) *
1-year survivors: averaged 12 cycles, 93% unfavorable or intermediate cytogenetics
30-day induction mortality: 10% *
* On Arm C. Source: G. Garcia-Manero, et al, Abstract 1061, ASH 2009 and Cyclacel data on file. As of December 1, 2009.
Great results like SNSS, but 30-day mortality is 10% compared to SNSS 3% mortality. I think CYCC has som safety or tolerability issues here. We shall see.
I still do not buy back CYCC because of small market size.
I am "no" long any AML drug company.
Let's take a look at CYCC anyway-remember CYCC earned SPA from the FDA where SNSS had never dreamed of.
Recent positive Phase II data in elderly AML patients showed:
Encouraging 1 year (12 freaking months) survival up to 35%: some survive many years and still going on and on!
Overall response rates up to 45%.
Remember CYCC will be LESS toxic than SNSS because it is orally administered.
Go to CYCC website and read their SEC filings and shiny research PDF paper just like Sunesis's.
Do not fall into AML track.
GENZ, VION and SGEN turned down by the FDA.
Sunesis into first place and break through the clinical inertia in AML.
"ODAC showed a decreased tolerance for approving cancer drugs based on single-arm uncontrolled Phase II trials, and denied applications for Clolar and Onrigin on that basis. Genzyme and Vion were asked to conduct randomized trials.
The setback has cleared the field, giving Sunesis an opportunity to pull into first place and break through the clinical inertia in AML. Sunesis had originally been considering a single arm approach for approval of vosaroxin, but changed course after the 2009 ODEC meetings."
There are still five to six others late stage actively developing AML drugs including CYCC with SPA in phase 3, all of which have good to excellent data.
I don't know where you got the perception that Sunesis is superior to all others
Maybe you trust too much into a blogger with followers.
Remember they are also have positions-longs. They buy and sell into their own advantages.
AML market is small, $175 million in 2009-that's a fact.
I don't know how SNSS could stay in this range with only AML indication, being the entire company relies only on one drug for a small and saturated market.