awesome. Thanks. This is a good report.
Concern is Janney doesn't hint at AA or partnership activity. CYCC shouldn't necessarily comment on AA, but analysts certainly could offer near term possibilities of MDS development. Janney looks towards a phase 3. Which begs the question: who is paying and how.
Also, where is that new nugget of info? the time between treatment failure and starting on sapa regimen. Why not PR that info if its so important?
My issue with CYCC is always clarity of message. Data consistent with expectations, but what are next steps. They could have even scheduled a brief investor update.
This is a BIG event. ASH.
Why not have 15 minute call with analysts on this presentation. Spiro said they were embargo'd from talking about it. Now we have to wait another couple months to hear more about it? They could certainly open up questions and provide investors a few questions about what was embargo'd data for 1-2 months. They should be drumming up support from the medical and investment community every chance they get.
Finally, regarding FDA. This data was submitted to ASH greater than 1 month ago. CYCC could certainly share that they are on the FDA's calendar to discuss pathways. I hope they don't wait till today to call because now the data is generally available.
When pressed for specifics, the company would at least provide yes no answers. Ie. Is there a meeting scheduled. JMP guy did press Judy at an earlier call. And eventually they said no discussions had specifically occurred or were scheduled (my interpretation). That should no longer be the case. They should be on the calendar and have an agenda set. They can say that much.
really? Why now versus 1 month ago, when the price was in the 3s? Unless you recd a new source of cash, I'm not sure I see what new info is now known that makes $4.60 a better buy than 30 days ago in the 3s?
new month / new cash makes sense. I did not see new data... Or any long awaited development plans. Today does represent short term speculators OR investors who believed news was imminent and are disappointed. No new news means they will leave and take out some stops along the way.
long term maybe. short term, with current leadership, saying "sweet spot is post phase 2" it can get whipped in any direction.
should be worth more, i agree.
good luck with your buys
why is it manipulation? Key inflection point came and went without any new info. People bought the move from $3 to $5 in anticipation of a big piece of news coming out. Short term players are moving on. Why is that manipulation?
Long term is what will Spiro do? "Post Phase 2 is the sweet spot..." We will see...
I think many on this board were expecting big things from the ASH data. People were counting down till ASH. To say that no one was expecting some new exciting data is not correct. Some were saying the key metric of time lapse between failure of prior treatment and sapa treatment would be made known and be a huge new data element and catalyst. Some bought the hype and are now selling.
The DSMB 200 patient review is a nice milestone for SAPA + AML.
Janney report was very nice. Says time to move to phase 3. But it leaves the market with a void. How will MDS P3 be financed? I wish the analyst would have expounded. Company did not have to wait till ASH release to start negotiating. Or talking to FDA. PCYC announced a partnership a week before ASH data release 2 years ago. To me they've had 4 years of MDS data to negotiate with. Milestone payments can be negotiated for great events like AA or good interim data.
Spiro said "Phase 2 sweet spot for partnering" before AML launched a phase 3 without one. Market sees that as being a possibility for MDS precisely because that is what Spiro did before. Every day that ticks by without a BP leaves the market questioning will a secondary be done to fund MDS phase 3. Especially during nice price spikes like we had.
Sprio could crush the naysayers by delivering a BP.
that statement by Spiro is same one he said past 3-4 years. And here we are 3-4 years later. Spiro has to execute. (ie BP)
The reaction is a little bit of hyped expectation. Many had it. Felt the weekend would be the time the company would HIGHLIGHT in a PR, a fabulous previously unknown data point. That didn't happen.
Not surprised by the reaction. Key is NOTHING is changed by the weekend's data release. IMO, that is why the selloff. Some folks thought a huge positive catalyst was coming this weekend. Not me.
PPS holding $4.50 is not too bad. PPS closing at or above where its at $4.60 would be a good sign IMO.
Personally I sold about 20% of position above $5. Holding most still. I feel like Spiro will be boxed in and have to do something shareholder friendly over the next 3-6 months. Almost against his will.
I am willing to trade some shares around the pps movements. I sold a chunk with the solid tumor data spike. And bought those back when it dipped to high 3s.
Twitter universe is becoming a little positive on CYCC. Probably a good sign after the swoon today. I didn't buy any of the shares I sold back. Don't need any more in my portfolio :) But today's sub $4.50 might have been a good buy
This posts sums it up. We didn't get the big sell the news drop yesterday because NVS was still out there. Today we're getting the follow through.
From a short term standpoint, jk did play this right. Bought the intraday drop and for the mini runup for NVS presentation.
NVS is a preclinical presentation, if I read it correctly. It would be fab if a partnership came out of it. But very very early in their research.
We are at that Sweet spot, right? Post phase 2!!! Come on Spiro!!!
now it all makes sense. He referred to himself as shareholder friendly and I knew he was joking.
But turns out he was serious about giving his shareholders lots of low entry points for adding more shares
l2l: are u sure? IMO, that is not a great stat. a few weeks would be good, but i thought mOS for these patients was 4 months. How could the average treatment gap be 5 months? If that is the case, these patients were surviving a long time without sapa.
Help me understand how that helps the data of this study? That to me makes it less clear if the drug was helping or not.
This will make a great point of discussion, IMO. Leads to all kinds of other discussions.
they appear to me to be option grants with an underwater strike price of $4.63. Glad they got yesterday's price.
wasn't there a slide that said the average mOS for these patients was ~ 4-5 months? It seems a little surprising the average treatment gap is 5 months? One could look at it in different ways, but it isn't clear to me that the huge gap in duration relative to expected survival is helpful to sapa.
l2l: what is the median OS for best supportive care for these patients? I'm assuming that is what they were receiving during the treatment gap.
precisely... so while waiting on best supportive care before entering the study, 5 months went by. half the patients died. Those sicker patients weren't given sapa [in effect] because they died before they got it.
Also, the patients in the study, survived for 5 months on their own without sapa on average. I don't think you can say they were aided during those 5 months by sapa. Statistically, that's a hard thing to determine. Many of those patients probably did get sicker in the interim, of course... And I believe were benefited once they started taking sapa. And perhaps had they started taking it sooner , better os... But I just don't think you can arbitrarily add the whole 5 months... And really tough to say how much it would have affected mOS.
So bottom line, that's the reason for a controlled phase 3 study.
So, its a good point of discussion, but I don't think its as telling and useful as one might think.
l2l: if they could include that in the mOS, others would also.
And if one believed it skewed results, wouldn't one try to keep that # down. After all, this is the 2nd cohort of patients. Not started that long ago. Why would CYCC have allowed those patients going for so long without treatment to potentially skew their data by entering their study, knowing it could take many months off of their published os results?
I think it is because it skews the results less than you believe. Again, these patients survived without sapa for 5 months on average.
And if it does skew the results so significantly, then CYCC goofed up big time by going 4 years of a phase 2 study and allowing this major data problem, knowing their published results would not include those months of surival while not on any treatment.
ice: don't think those kind of ethics play into clinical trials. Esp with unapproved meds. The study can have include or exclude criteria that prevent a dying patient from entering. Sometimes fda sets up compassionate use options, but think a drug has to be closer to approved than phase 2. Example, perhaps while fda is reviewing application for approval
Might be the best endorsement you are going to see. "Nobody can suck that bad"
Spiro has said post phase 2 is the sweet spot for partnering for 4 years now. Now two indications are post phase 2. Let's see if that is what he meant. Post phase 2 in TWO indications is the sweet spot.