RE: What are the rules?6 Jan 2022 18:53
Firstly I'll direct you to two companies who both unsuccessfully went through p1-p3 trials to give you a flavour of what's rns'd, mtfb and imm. There's an argument to be had over imm
When conducting trails what are the key pieces & sensitive pieces of info
Not when something is submitted to the FDA - but when it's accepted. So many applications/decisions are rejected or requiring extra info in small cap. Firstly you need to consider the size of the document - it's huge and when you have small teams - is science/sales/ admin the priority? Often people in small cap have experience in one area not all. It's a much bigger hurdle than people recognise on aim, imagine 200+ page document all perfectly annotated and cross referenced multiple times. It's immense
First patient in, means the trial is up and running often rns'd, definitely the last patient dosed.
SAE's serious adverse events always have to be rns'd and could lead to stoppage of trial. People take no SAE as "drug is safe", not true.
They often rns new hospitals, not really sure why? I think this is more down to PR than anything - people say "the trial must be going well" - no. It means that there are no SAE's
There is always a review of the data, this can take longer than most people think. People will get twitchy around this time, why is it taking so long? Must be good, must be bad? - no they have a small team and want it to be right. Again, rns on acceptance of application
Then the decision obviously will be rns'd
Depending on what stage - move onto the next or final decision
In terms of updating throughout the trial, people always want updates. ABSOLUTELY NOT!! For so many reasons, first you don't know who it's going to work for? What happens if the first 10 patients out of 200 nothing happens? Release that? But then the next 50 it works well for, or vice versa? It's really important also when the FDA are looking at the submission -;they do so without bias, if they were already aware of trial info then it's not objective. At all stage.
It also depends on how the trial is set up, you can have double blind trials? Placebo trials? Where even the clinicians don't know what drug they are administering, again this is to help prevent bias and word spreading of a miracle new drug.
That is only the starting point, you'll read an incredible amount of rubbish on these bb's, some decent stuff too. But it's really important than you familiarise yourself with trials, because waiting is a killer on young pharma, especially when you can be talking about seeing 80-90% of your investment going, or conversely getting a multi-bagger