Member Info for _Mr_Big

Just forget about this one. It will correct itself over the next 12 months. Can't expect much more I'm afraid.

I'm pretty sure this will recover. Market overreaction due to low liquidity imho.
Hopefully, within a couple months. Worst case - a year.

I bought £10k at 130 the day before the RNS lol.

A good post from "the other board":

"I think I remember reading that Europe was probably 2 years behind the states so doubt this would be a preferred route
GR
I am with you that equivalence could be the issue
If you listen to the first questioner on the last Equity Development presentation he asks...."Because graft submitted is non biogenic is there a risk they are considered 2 different products and might not demonstrate equivalence "
Bill takes several seconds to consider the answer and acknowledges it is a good question and suggests John Ely felt the relevance to equivalence was in the healing process within the graft and didn't consider it as an issue
We obviously need clarity and as Bones suggested hopefully this week
The fundamentals of the company haven't changed in my opinion. They still have world beating product and hopefully a BOD capable of delivering it.
I do expect this to bounce strongly when the uncertainty is addressed.
The sooner the better"

Yeah. I guess they had to issue the RNS about the delay and now are trying to figure out the details.

Possible outcomes:
- More data requested by the FDA. Clear timelines given. Easy sailing from there. Bounce back to 160.
- 510k route not applicable to grafts. We're f.cked.
- Anything in between.

Pre-submission process is 75 days. Then 510k review is another 3 months. So we might be looking at Q2 for launch at best.

The big question if why the f.ck did we not start with the pre-submission process anyway (especially if we got delayed for months by the contamination). And how competent is our reg team, if they managed to f.ck up so much. What else have they missed.

SP action is based on low volumes - I hope it's just some PIs panicking. Could be, of course, that IIs got tipped off and they are now dumping stock.

I'm no expert, but giving it a quick read - the 510k submission relies on new grafts being equivalent to the ones already authorised by the FDA.
It seems like the FDA have asked for more information to prove equivalence. Since we got converted to a pre-submission status (rather than an outright rejection) one would hope that we just need to supply more data to clarify our position. Which could mean a quick resolution and a rubber-stamp or could mean further trials and god knows what.

The uncertainty is killing the action right now. We desperately need an update from RUA.

Yeah, my 103 top-ups are looking sh.t too.

£5 over the next 2 weeks.

That's AIM for you. A company drowning in debt and making no revenues but promising to capture unicorn farts to revolutionise renewable energy sector will attract a lot more attention than a boring workhorse raking in profits. Such is the nature of a dumb AIM punter.
Find a good one; buy in low; wait for it to become sexy.
They all do, eventually, the biggest question is how long you're prepared to wait.

Picked up some shares before close.
I think we're in for a big Monday...

Does that mean we're going back to mid £4s?

Yep. And I got a warning from the admin for my email gag the other day.

6 months?
You must really like them ladyboys!

That's the sound coming from DA when he's at his desk...

Board unreadable today.
Note to self. Buy more. Sell back at higher price to dribbly when he needs to close his short.

Makes me wonder why we've not had another UK gov order. We sold them £4m worth of promate a few months ago - surely that must have been used up by now?

Blu - f.ck PIs. Sp is fubard beyond all recognition and we have close to zero II support.
Is there anything the board can do to get IIs on board?

So I can load up on cheap shares ;)
https://knowyourmeme.com/photos/2062076-moar

Don't get me wrong - I'd love to see 235 again. Just need to lube up the "buy" button well in advance.