Hi No Vice,I know that feeling mate, after how many night...

Hi No Vice,

I know that feeling mate, after how many night shifts? It messes with your head, sleep deprivation! Glad you got home safe (400km!) & get some rest. The $2+ delusion or dream must have been a pleasant one lol, or just hit the wrong key

News soon, we are into week 8/10 following pre-sub to FDA. Ph2 Janssen ANN on Interim data should be due soon also, we are almost into April! Endometriosis news overdue on Biobank consortium to support clinical trial.

Now please don’t worry about this people, but an update from CMS on the ruling for Breakthrough Device Designation from FDA & instant use & approval of Medicare coverage.

There has been a 60 day delay on this ruling under Biden, to allow for public comment, & this was off the back of Physicians who questioned this as an overall ruling, ie some tests/drugs will be of maximum benefit & maybe some won’t, so it’s sensible I think & this public comment period should have really been the process anyway:

https://www.lexology.com/library/detail.aspx?g=901f37b5-01e2-4219-a9aa-18045a99f694

This does not change breakthrough technology/drugs being awarded Breakthrough Status by the FDA, it’s the Medicare coverage by MCIT ruling that has been delayed to allow a 30 day public comment period. A few articles out there, but this one breaks it down.

Its just an update, & not something to worry about, but I thought you good people here would like to know, if you don’t already. This may have accounted for some selling, in that the benefit of PD won’t potentially be as immediate as a month away to US Health via this programme (Breakthrough Device Designation FDA timeframe is 30 days).

I agree with No Vice though, sell downs are very suss on low volumes, I’ve stopped looking, because it pisses me off, the injustice of it (hitting stop losses etc). I’m still feeling very comfortable where our SP is sitting, but for investors that bought in later on the jump to $1.48, it must be frustrating for them. Hang in there guys.

I do have a feeling we will come away from this pre-sub with a recommendation for BDD Status, if Richard hasn’t applied for it already (see previous posts on the topic for more info).

I hope everyone is having a lovely weekend.