ice: i think not likely to hit 1/2 billion market cap before top line read out.
BUT, i think a pre-futility run and assuming a positive outcome of futility, a subsequent run into top line data is in order.
If CYCC gets to 200M+, they should do a secondary for pipeline development
you make allegations, i try to refute, and you reply without even beginning to address what I said. Instead calling me faking ignorance.
Willing to lose it all is your statement. I refuted, you call me faking ignorance? I don't understand your line of reasoning?
willing to lose it all? I don't see holding here a statement of willing to lose it all. I think I saw him say he'd be willing to sell a chunk at higher pps (pre catalysts) and hold a small percentage all the way through.
Its not all or nothing... That's my investment approach here too. Sell into run ups if they occur and hold a few shares all the way through.
how is what i said nuts?
How is it not logical to be upset at mgmt for past 2-4 years of pps performance?
How is it not logical to hold shares now even though think mgmt is not doing a great job due to near term catalyst that mgmt has 'little control' of the outcome?
ice's negativity/skepticism is a logical human response to what has transpired to cycc over 3-4 years.
In fact, its a lot more normal than whistling gleefully seeing an investment loose 80% of value.
And folks ask why hold shares when one is so negative.
I'd say, again, not an unusual human reaction. As much as he is ticked at mgmt, he sees selling as being a 'worse' mistake as 1. he's effectively absorbed the risk with the pps losing a signficant chunk of its value. 2. the near term catalyst [futility] makes holding at least a bit longer well worth the risk/reward from here. 3. Finally, there is little execs/leadership can do between now and the biggest milestone in company history to affect the direction. The results will dictate.
Market expects failure of pipeline and failure of SEAMLESS. Any hint of hope from either drives the pps north.
ice: i think the leadership factor does significantly impact.
It may delay the start of an upward movement and limit the upside.
It also may be a lot more volatile with many happy just to get $3.50 or $4 or $4.50 and bailing never to look back, precisely because of sentiment towards leadership. A lot more weaker hands.
I would say, though, the market can't resist possibility.
I don't know who, outside of this board, listened to the Q2 CC. But SEAMLESS hitting 70 percent was encouraging. The fact is they doubled the pace of enrollment when they specifically stated they were looking to speed things up. That should have gained leadership at least some credibility to anyone listening in. I think seeing the continued acceleration at the Q3 CC would get people's attention [perhaps hitting 85 percent].
So I think its wrong to think there will be a SNSS like run (5x pre top line read out), but I also think its not unreasonable to see renewed interest with the 300 patient DSMB PR. And getting through Q3 CC with enrollment continuing to pick up pace. Any prediction of full enrollment even by Q1 2015 and futility coming between Q3 CC and Q4 CC, will encourage at least some investor 'anticipation'.
The continued lack of significant update on any other pipeline for 18 months and the slow pace potentially positive prestudy activities of MDS, has allowed the drift mostly downward.
But accelerating enrollment in SEAMLESS is now front/center and soon, the biggest milestone/event in the company's history will come. It could come without warning after the Q3 CC and before Q4 CC.
Maybe, the 300 patient dsmb reminds people SEAMLESS is in play/and pretty soon.
yahoo message board stinks!!! chops after less than signs... bug!!!!!
this could just be a pump post... sorry in advance...
bottom line... per F-R rule; less than 300M yields 0% previous success rate in phase 3 for oncology drugs. in past 10 years +
SNSS climbed from $1.20 to over $3 before its futility and spiked to $6 on futility. hovered between $4 and $6 until this year when it broke over $7. That's a 5x gain.
CYCC needs about 4x.
Is it time to get bullish? SNSS drug is not stellar. And yet time + futility has gotten significant pps appreciation from SNSS. Could 300 day DSMB get the clock ticking in minds of investors in terms of SEAMLESS futility...
Might almost be time to put a buy rating?!?!?!??!
Put the potentially positive survey possibly leading to pre-RMDS-phase2b-study activities on the back burner (i know that's pretty huge)... and when the 300 patient DSMB PR hits, start the stop watch on SEAMLESS futility!
couple typos :)
30 day per month mOS instead of 30 day mOS
understand theirs IS refractory (not if)
Now, have a great weekend!!!
ice: i think it is a great question. quick answer... maybe more this weekend...
1. i believe sapa is active. needs combo. combo efficacy with 30 day mOS is not that much better than daco alone. [recall my 5-6 week advantage prediction] mOS won't get sapa approval, the tail of the survival curve could.
2. AML has 0 approvals in a bazillion years in US. sapa is not stunning. so why different. Drive by media has dismissed.
3. borderline approvable efficacy + Spiro as CEO is a lethal combo [i predict 50/50 shot at ~.80 HR which would be approved IMO in EU at least] ; that misses SPA endpoint.
4. company moving super slow with enrollment [i believe 2015 completion is about 1 year behind original targeting]. SNSS added quite a few patients and is finishing sooner. Understand theirs if refractory...
WIldcard. the AF rule i believe has a market cap range and is also time driven ( 'near' top line read out). What is the low end of the market cap? And if CYCC did 1 more dilution pre top line read out, could a run to the old $8 be enough to get it to the low end of the AF rule? We are probably 12-15 months away from top line read out. If CYCC does make a run post futility, it would be foolish for Spiro not to dilute for the needed p3 in MDS if SEAMLESS fails.
have a great weekend...
When you look at it that way, there has been alot accomplished.
4 more months left in the year... Some big ones coming up too.
potential positive survey results followed by possible initiation of pre phase 2b activities.
I wonder if they'll be providing any color on the survey results? If they are reaching out via phone? or email? In person through a 3rd party?
I wonder if they will provide an enrollment update for survey participation. They will probably get the survey translated to other languages so they can open it up to European enrollees.
A big catalyst would be full enrollment for the pre phase 2b feasibility survey. Then top line results will be announced. They might do a futility based on the early survey results too.
Lots of 2014 catalyst ahead.
thank toowan. he kept bumping the post. He clearly saw the acceleration of RDMS potential activities that the Janney analyst was targeting.
That analyst read between the lines and got out the rapidly evolving potential pre-study activity.
all the credit to toowan and Janney
jantham: yes, they are rushing. But this is for a huge unmet medical need. Clearly there is urgency when analysts are willing to target things like potentially positive feasibility surveys. And further targeting if such potentially positive surveys become reality, that pre-study activities will actually begin. And not only will they begin (note the word WILL and not MIGHT), they will begin THIS year. As in 2014.
Thank you toowan, for publishing the Janney note. Clearly they are using their crack analysts to produce some very aggressive forward looking statements aournd the cycc call. I really wasn't focusing on the RMDS update (I was targeting SEAMLESS). I feel like we could be seeing treble pre-study activity before we realize it.
Janney did NOT elaborate on what would occur if the feasibility survey was not positive. At this stage it is only potentially positive. If I read Janney's words correctly, potentially positive leaves the potential for a negative outcome to the feasibility survey.
If the feasibility survey were to be negative, I'm guessing that the company would not initiate pre-study activities.
I guess we hope the potentially positive survey turns to a definitively positive survey, so we can get to the pre-study activities THIS year.
They should definitely add this to the 2014 milestone list:
"turning the potential of a positive survey to the reality of one."
And it goes without saying that you would then add 'starting pre-study activities' to that list too.
This will be one to hone in on for the Q3 CC. Did the survey become definitely positive and are we likely to see pre-study activities before year end.
Quoting the MDS update:
"...Management is currently evaluating the feasibility for the study. Following a potentially positive feasibility survey, the company will initiate pre-study activities this year...."
I find that statement pretty stunning in terms of 6+ years after initiating the phase 2 in RMDS. 'potentially positive' and 'pre-study activities THIS year'.
Seriously, THIS year we'll be seeing pre-study activities.
Janney analyst pretty pumped about the decisiveness of RMDS program.
This is truly amazing progress to be able to be so assertive.
I think the Janney analyst should temper the comments a little. It sounds a little too much like over-promise.
twitter has the defense article... posted by none other than adam f himself.
twitter handle = adamfeuerstein
search for $PCYC DB defends
The lead-in portion (blue), appears to not extend past 640-650 days, so perhaps at the cutoff date of the data release, that portion of the patients wasn't on the study long enough to hit 24 months (730 days).
I wonder if they followed the patients further.
In theory, the red line (all patients) should have stopped where the blue line did since the red line and obviously shouldn't have extended past a group of patients that hadn't been on study past 650 days.
Maybe a goof?
with Celgene/Revlimid the story would periodically be reconstituted as 'new news'. Until finally their MM-020 rev+dex trial blew any worries about SPMs being linked to Revlimid out of the water.
in studies, Revlimid was used with melphalan and showed higher SPM incidences.
Without melphalan Revlimid had a much cleaner profile.
The story repeated periodically similar to today's PCYC story when someone 'looks' for data.
JMP's reply to today's story is stating that single agent is clean and the incidences show when used in rituxan combo. And that rituxan has a label which includes PML.
JMP goes on to say that culling data from the FAERs data is subject to bias versus even a phase 1 trial, which would more properly report AEs