Hi Ben
With respect - I understand what you are saying but I hold to my comment that "
“IMU has no set obligation to report on trials at any particular time.”
However I think that I did not make my meaning clear when I wrote those words. To be more specific, what I was trying to say is this:
Raw data and "clinical results" are not the same thing.
The clinical trial generates new raw data every single day, but that does not mean the company is obliged to report that data every single day - or on any particular day.
You mention the "
bile duct cancer patient" who was "cancer free for more than 200 days.
" A great example! Let's assume that person is still alive today. I hope so!!! I don't know how many days it's been since they started the trial - but it will be something like 266 days now. Now let's assume they are still alive tomorrow, and that fact is reported back to the company. Is Imugene required to issue an Announcement that the patient is still alive 267 days after starting the trial? Are they required to announce on Tuesday that they are now at 268 days? And then 269 days on Wednesday?......
The answer is
no, because the fact that the patient is alive is just "raw data" and is not fit for publication or announcement.
Scientifically meaningful and verified clinical
results are another matter. Those results would include verified data on cancer scans, for example. ie is the patient still cancer free or have they had a relapse? If so - how many tumours? What is the tumour size? How does that compare to previous scans? etc.
Even when scans have been done, it is till raw data until verified and analysed - which is time consuming and potentially disruptive. LC explained the difference in some detail in her answer to a question in the last investor webinar. They are not required to go through that process every day, or even every time any particular patient has a scan taken. To a large degree they can choose when they do that work of collating, processing, verifying and analysing results.
I
do agree with your statement that that "
if they are in possession of biopsies from the Vaxinia Trial, that have been subsequently peer reviewed, which may be deemed as price sensitive to the market, they MUST DISCLOSE and are duty bound to do so."
What I am saying is that the company can choose when they undertake the work to collate, verify and analyse data to produce those genuine clinical trial results, and they don't have to do that at any particular time (apart from adhering to their clinical trial plan).
Once that work
has been done then yes, they do need to make an Announcement of significant verified results in a reasonably timely manner, but even so the ASX does allow for clinical trial results to be held and announced in conjunction with a conference or a peer reviewed journal paper - as long as the information is not allowed to "leak" and is not used for insider advantage. So really - we are saying the same thing, my friend.
For readers who may not have heard this, I suggest l
isten in from 22:35 in the most recent investor presentation video when Leslie states:
"the information is entered into a case report form.... it has to be evaluated against the medical chart.... there is a professional that has to go out to the hospital or clinic and verify .... and in addition to that it gets entered into a
database, then it's statistically analysed... it is a lengthy process
and we only want to do that when it is necessary for a submission into a major cancer conference and things of that.."
Source:
Very best wishes to you Ben
I do agree with most of what you say!
Cheers
Dave
