RE:RE:Speculating on the content of the 6/21 call "Paul - intro and headlines on trial so far, fastrack, little bit of market potential (say billion at least once)
Beliveau - science/history Christian - trial update, as much detail as possible Paul - closing remark Q&A - fat and juicy." Yes. Maybe the B word should be said more than once but to me that's a great way to present the process.
qwerty22 wrote:
I'm a little bit weary about there being too much substantive data from the trial at the event. The press reported that the first patient received his second dose on Tuesday 6th Apr. That would mean that if there are no adverse events then he would be receiving his 5th dose today. Which means he'd likely only received his 4th dose when this event was planned. It also means he only gets his 6th dose after 6/21. I hope I've got the timing of all that right!
So we could guess what that means for each of the different types of data they are generating in part1.
MTD/safety - these are linked because MTD is based on the emergence of safety signals. If a toxicity signal has emerged at lower doses this is somewhat negative. It's earlier than I would hope for, it's earlier than the preclinical data might point to. If this event is based on the announcement of the MTD then it's not a positive. I'm hoping SAE only appear at the highest dose (or not at all). It's not unheard of for companies to not reach the MTD at the end of dose escalation, I'm hoping we are in that category, and so I'm NOT hoping for some firm MTD info. Hopefully they'll be saying we've reached dose 5(?) with no SAEs or high grade toxicity. I hope they are just ruling out negative early events.
Efficacy - Hard to be certain we've reached efficacy. My GUESS is efficacy happens in the range of dose 3-6 (if the drug works that is). We'd be super lucky to have shrinking tumours at dose 3, I think preclinical points to 4/5/6 but with the caveat that preclinical might not be a very good guide. Assuming you want to see a shrinking tumour on one scan then see it again on the next scan to confirm it then that puts us right on the cusp of efficacy. It probably means we'd have to be really lucky to have a reliable efficacy signal when they planned this event and we'd be doing very well to have a confirmed efficacy signal by the time of the event. I'm not holding my breath for an efficacy signal, but it's possible.
PK/PD and other bio analytics - This could be very useful data. Showing the drug doesn't get degraded in the blood or that there is no detectable free docetaxel in the blood is very important for good therapeutic window, but I tend to think this is most meaningful at the higher doses, the dose that's likely to move to Ph2. Maybe PPD are doing this work in their labs on samples as they become available and have data on the lowest doses, it might be useful to hear that but again we are only just reaching those doses where it's most important now so it's questionable whether they have the data.
So overall I tend to think we are only just reaching the exciting point of the trial now. If they planned this event in late May then that seems early to have exciting data. 6/21 is right on the cusp of exciting data flow. We've talked about the need to prime the market. This event might be more of a primer for what comes later. My expectations have been for more substantive data to come in late summer rather than June but we will see. They can certainly rule out any negative events happening at the lower doses, maybe something exciting has happened earlier than I believe. I'm bracing myself for this mostly being a well executed primer, an interest building event rather than the main show.
Having said all that I'd agree with you about Beliveau. He has to be there just for the science/history of the drug, not to deliver trial updates. If there is substantive trial info they need to headline that at the start to give people a reason to keep listening. I'd like
Paul - intro and headlines on trial so far, fastrack, little bit of market potential (say billion at least once)
Beliveau - science/history
Christian - trial update, as much detail as possible
Paul - closing remark
Q&A - fat and juicy.
SPCEO1 wrote: Let's just say at the outset that I and a few others here appear to be the only ones specualting on the content of this call at this point as the tepid trading volume on TH's shares indicates no one is working hard to pre-position themself in the stock before any news that may be reported on 6/21.
Now, one has to believe that whatever news will be reported will be positive. It may not be much news or super positive, but if they called this event to report bad news, then that would be quite a remarkable situation. So, it is safe to say any news will be largely positive. There may be some pieces of info that rasie questions but, on balance, we should be leaving the session thinking we heard mostly good news.
1.) Hopefully, they will start the session with the update on the phase I trial and not hold that to the end as they might lose some people if they do. The most logical update on the phase I is that they are nearing completion of the first part of the trial and they have either already identified the maximum tolerable dose (MTD) or will soon be able to do so. Either way, the MTD is likely to be large enough to make the second half of the trial worth paying attention to. This type of news is actually very good news from my perspective (the trial is moving forward) but I am not sure the market would react to it in a big way. From what we know already from the mouse models, if the drug is shown to be safe enough to finish the trial, there is an increased chance the drug will also shrink cancerous tumors. We know how the drug works so if it is safe to use in humans, that is a big deal to me.
2.) On the downside, they could just focus on the background science for the drug with Dr. Beliveau and not give a meaningful update on the cancer phase I other than saying positve generalities. That would be disappointing to us but still could be useful as an introduction to others.
3.) On the upside, they could tell us the MTD has been found and there have already been some early indications of tumor shrinkage in various patients with various types of cancer.
They could also expand upon the science they have already shared with investors. One has to assume that they have been working hard in the lab to advance this project and to come up with another version that is even better - along the lines of what JFM and others have been talking about.
What are you expecting them to say on 6/21?