xml3228

I feel it would have been quite important for OP to be transparent about the availability (or lack of) long term follow-up data. From a scan of what OP provided above, there is no clinical trial data reported beyond the 8-week or 30-day post-intervention period. It is not possible to validate any claims (certainly not for treatment more broadly) beyond what is simply described in individual case studies.

To be honest I like a good devil's advocate but in this case the guy's responses in this thread just don't provide much confidence to anyone who cares about study design, conduct and reporting standards. His responses do the opposite of that.

Not sure about whether the person is bullshit but OP responses to some questions here feel to be disappointing to me (both from a scientific and style perspective). It is not really to the standard I would ordinarily expect of an academic or clinical trial PI (I'm not sure if he was a PI).

Edit: Just seen he is a CMO - not sure if that adds to the disappointment.

Edit2: After reading more comments I'd actually be shocked if OP really is a CMO (or dare I say even the qualified person they sign off as, but I'd hope Reddit verified the person)

Not disagreeing with your tldr but several statements here are misleading, or at least don't provide a full picture for the less informed.

Of approved products, I'm not sure I'd call high quality double blinded phase 3 RCTs "rare", and at the same time there are some valid reasons for that design not being appropriate in certain circumstances (where it would be unethical to give someone placebo, for example). Flexibility in several of your points above including surrogate outcomes has also supported funding as well as genuinely rapid development of potentially transformative or curative drugs including cell and gene therapies. Now, there's no judgement as to whether this investment is well spent compared with what else could be funded. But certainly, people can and do benefit from recent innovations.

Edit: Some points above don't apply to this post about PTSD of course so it's slightly off topic. As critical as this might sound, regardless of the intention or study results linked by OP, the manner and quality of some of OP responses is slightly disappointing from a scientific perspective.

Ah, agree on that one. Anticipated issues would be expected to be covered in exclusion criteria rather than specifying contraindications