I don't know how many times I've reread the announcement today... here is another point I have to make:
Dr. Havron said: "we are increasingly confident that the Phase II trial will provide sufficient information to enable our researchers to establish the most suitable DOSES", (not Dose).
Novik always says: "We knew are product works, but not what the dose should be".
And now Havron adds that he is more confident that the trial will point them to the right DOSES they should chose for phase III.
What that means to me is that Prolor decided that the interim results are GOOD ENOUGH to go forward with a phase III trial, but it very well may be that they still are not sure what the perfect dose is (hence doses).
Looked at this way it would be interesting to see the actual data, but the most important thing would seem to be what the FDA would actually demand for the results of phase III, meaning how many (% wise) patients (if at all) will be allowed to be a day or two outside the normal range in our best dose in phase III.
All i know is i bought another 1000 shares at 5.70 and another 1000 at 5.71... the technology is sound and it has been justified to me with a semi successful phase II data release.. although at 1 week dose intervals instead of 2 week or a month.. What i have to ask you is the following: Isnt that in and of itself good enough? If it turns out that this can be dosed every 2 weeks or monthly, isnt that just the icing on the cake? Would you not prefer to take a shot once a week versus daily? Really? Is this not life altering already?
Short sighted = stupid. And i am glad such stupid short sighted people exist that i was able to make an additional G today because of them..
I'd be happy to do that but haven't spent the time thinking through the issues raised to precisely craft the questions. In other words, if you or someone else wants to post well crafted questions for IR but would like me to act as email messenger, I'd be happy to do so. Otherwise, I have other things I need to focuse on before I can devote the time I think necessary on these issues and precisely draft questions for IR.
About 5 minutes after the announcement I sent an email to info at prolor containing about 3 questions that instantly popped in my head so I will wait for those to be answered before sending more myself.
Bitechinvestor, why don't you take on that job yourself and share their response with us?
I think this entire discussion is excellent but at the end of the day it all comes down to conjecture.
I think someone should email the company with a carefully drafted series of questions aiming to clarify the issues raised in this thread. (And it would be great if the questions submitted were posted here pending some sort of reply from PBTH IR.)
One possible explanation for this (my theory)is that because the "low dosage" group took say 6 weeks to complete 6 injections, their results were ready first (becuase it would take 12 weeks to complete 6 injections on the longer acting group). Of course you can argue that you can measure the efficacy of the "once every 2 week" group during the same time period, but there would have only been 3 injections. What im saying is that it may be that for the study to be statistically satisfying, there is a "minimum" number of injections to be met. Therefore the group that is aiming for 1-every 2 weeks will take double the time to complete.
Well, if we assume that the once every two weeks dosing cohort has such a little number of patients in it (what? like 5? 8?) then management mislead us by telling were seriously thinking about an injection every two weeks, looking back on it, even if the cohort was 12 patients, were they seriously going to go for the 2 week dose in phase III based on data from 12 patients? the answer probably is only if all else failed (all other cohorts). So it seems the weren't serious about the 2 week dosage.
Again, if we can find a good once a week dosage it we should be just fine (just like Elonva).
And yet again, I have to say I raelly don't enjoy the management's "style". We are deliberately kept in the dark to some things, that much is clear to me by now.
Well, if you assume the first three are the same size and that that 4th is much smaller, then it works. 34*3/2 = 51 which is less than the 56. So maybe there are just a few in the experimental group.
In rereading the announcement, I agree with you on the current expectations of seven days. Definitely one shot is better than seven but I understood we were looking for two weeks. Hope that is clarified in June.
I don't know John, it seems to me pretty clear that the efficacy end point that is talked about here is the one week dosage:
"Efficacy in the trial for the cohorts receiving a single weekly injection of hGH-CTP is defined by measuring
whether these growth hormone deficient adults can maintain insulin-like growth factor 1 (IGF-1) levels
within the desired therapeutic range over a period of seven days. The interim results from the “lowdosing”
30% and 45% cohorts suggest that this efficacy endpoint is achievable"
notice the line "this efficacy endpoint is achievable" this = the one week efficacy point talked about a couple sentences earlier.
Another thing I don't quite get is that as far as I understood all four cohorts were supposed to enroll about the same number of patients.
While the announcement states that Enrollment in All Study Cohorts Is Continuing, even though we already have 34 patients from the 2 low dosage cohorts.
that doesn't add up to up to 56 patients total no matter how you look at it.
In my mind at least it doesn't really matter whether we
it's a shot every week or every two weeks, patients would still be so much better off, and the market opportunity should be very significant, I just wish they were more clear with us about this announcement.
It seems some points trying to be made and some of the phrasing is just not very well thought through.
They reported the cohorts they had avaiable (lowest dose). Instead of looking at it from a "conspiracy" point of view, look at the other side - WORST case you inject once every week instead of daily.