This is a classic case of reading a regulatory update like a tabloid instead of like a clinical disclosure. You should be on “The View” or CNN. A perfect example of grandiose delusion.
First, “the company responded to me”
Public companies do not issue PRs based on message-board posts. They issue them when:
• follow-up milestones are reached (e.g., 12-month safety windows), and
• counsel clears what can legally be disclosed.
The timing here aligns with one-year follow-ups, not someone “pressing” on a board. That’s correlation cosplay, not causation.
Second, “several patients” and “instances”
Those words are not evasive — they are required language when:
• sample sizes are small,
• analyses are ongoing, and
• data is being prepared for regulatory submission.
If the company did quantify outcomes prematurely, you’d be the first to accuse them of over-promising. This is exactly how compliant disclosures are written.
Third, safety vs efficacy
This PR is clearly framed around long-term safety, not final efficacy.
That’s not suspicious — it’s sequential:
1. demonstrate no serious adverse events at 12 months
2. expand protocol with tighter imaging and monitoring
3. support regulatory submissions
That’s how first-in-human oncology devices progress. Chemo, radioembolization, and brachytherapy all followed the same pattern.
Fourth, whole-body PET and lymph nodes
Nothing is “off” here. FDA often asks for broader imaging to:
• rule out migration
• confirm off-target safety
• characterize systemic exposure
That doesn’t mean the indication changed — it means the monitoring framework expanded, which is exactly what happens after early human use.
Finally, “stringing people along”
If this were theater, you’d see hype and superlatives.
Instead you see:
• conservative wording
• safety-first framing
• explicit references to FDA feedback
• incremental, auditable steps
Looks like the chair has been pulled out from under you one too many times.
Huge swing and a miss!
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