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4.1¢ incannex healthcare limited

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Greenwave17

931 Posts.

566

28/11/21

17:44

Post #: 57916553
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Originally posted by comincon: ↑

@Greenwave17

the misconception being peddled is approvals can be secured through the FDA using real world data then evidence.
I think you'd agree thats a fairly common and generally accepted conclusion?

'but then you have the fda supporting it'....the following is the FDAs' stated guidelines on the exact subject - it is not ambiguous or open to interpretation ( though it seems a fairly regular occurrence)

the opening introduction to the FDA guidance framework for the use and implementation for real world evidence are as follows:

download (fda.gov)

For a drug already approved under section 505(c) .....or to help support or satisfy drug post approval study requirements.

I think you'll agree there are currently no approved schedule 3 cbd drugs/new indications available though the TGA ......nope! None.
none are able to satisfy the requirement for so called RWD/RWE because there is no appoved Sched 3 ( these must meet the requirement for trial outcomes to establish safety profile and efficacy, that 'label claim' I refer to monotonously ....before approval criteria is met.) other than GW Pharma / Epidiolex ....the only one.....

Relevant to RWD and RWE the agency defines:

so it is easily understood that Companies who claim they can collect RWD to support RWE for a clinical trial to gain approval are dealing in 'smoke and mirrors'...
as the introduction made clear,
it is ...For a drug already approved under section 505(c) .....or to help support or satisfy drug post approval study requirements.

this is pretty clear - please correct me if im off the mark here on this framework / guideline to implement RWD and RWE into the process on currently approved indications or drug post approval studies

so simply an 'initiative to pilot projects that further the understanding of potential uses of RWD and RWE.....' for previously approved indications or again for drugs of post-approved status / studies

to each their own? nope @Greenwave17....not a case of interpretation - its guidelines are very clear and have been since day 1.

I hope Ive helped shine a clear light on the process and framework....but probably not.

See you all on the other side - keep an eye on the market

see you all on the other side of this - good luck to everyone with the upcoming developments and news flow from this exceptional company, both management and research teams ....imo the BOD is everyting about success when investing in startups and this Incannex team really proves that philosophy.

Really enjoyed the banter and information exchange this year - learnt so much from everyone here about the market and investing that i have not seen on any other threads really - this company thread is exceptional and imo should be held dear for that exact reason.

Hope everyone has a great and merry Christmas - see you all in 2022

GLA and may the season be kind to each and every one of this community.

Expand

First off, I never said it will lead to approval....so you are insinuating by putting words in my mouth there.
Yes, FDA does support and appreciate it's use.
The "cures act" was signed into law in December of 2016. So, I'm sure you can agree (probably not though) that RWD/RWE is still a very new concept in the medical world.
I'm sure you can also agree (maybe not), that the world is increasing moving toward a "Data" driven society.....it's already happening and covid has accelerated that massively !!!
No, you did not shine a clear light on anything except your own ignorance. For you to say that RWD/RWE, has NO value and is all smoke and mirrors is just completely wrong. As I said, the world is increasing becoming a data driven society....whether you agree or accept that or not, I could care less !!! I bought into EMD before Palantir or Twiggy showed up and have done very well out of my investment....I'm happy !!

Here are some other points worth considering, but I'm sure you will chose to ignore its value -

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Hope you have a Merry Xmas and great New Years bud.....I know I sure will be....Very sure !!! Cheers

IHL Price at posting: 55.0¢ Sentiment: Buy Disclosure: Held
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