PEB - Pacific Edge Ltd

[nextbigthing]

knock, knock, knock, knock, knock, knock, knock, knock, knock

For the benefit of any whom may be mislead, although I really do doubt many take any notice of knockers;

Pacific Edge do not have FDA approval because the FDA do not provide approvals unless a biotech company operates laboratories in more than one state, or if the test activity is performed outside of a laboratory potentially across multiple states, eg: a test that can be performed at home, potentially anywhere.

Pacific Edge are required to have CLIA approvals, which they do have, as administered and provided by CMS.

The FDA does though develop rules and provides guidance for CLIA.

Unlike knockers, US insurers know what FDA, CLIA, and LDT mean.

MAC, does that mean that they won't be able to roll out the 'direct to the customer' internet option in the US without FDA approval then?

Disc) Some in holding portfolio, some in trading portfolio

[nextbigthing]

knock, knock, knock, knock, knock, knock, knock, knock, knock

Who's there?

[MAC]

MAC, does that mean that they won't be able to roll out the 'direct to the customer' internet option in the US without FDA approval then?

Disc) Some in holding portfolio, some in trading portfolio

Not sure what the reason might be Nextbigthing, could just be a bit early in the US yet, or perhaps they would prefer to talk to the Urologists when they order still for now.

Provided PEB only perform the tests in a single laboratory, I don't think it matters where they sell to or where the sample kits get sent to in the US, or how they are ordered, directly or on the internet, unless there is some specific regulations covering what can or cannot be ordered online, not sure about that one.

[okay]

Stalin: Knock, knock
Comrade: Who's there?
Stalin: I ASK THE QUESTIONS!!!!

What was Stalins only hit single?
Every breath you take I'll be watching you.

Courtesy the late Robin Williams...

[Minerbarejet]

MAC, does that mean that they won't be able to roll out the 'direct to the customer' internet option in the US without FDA approval then?

Disc) Some in holding portfolio, some in trading portfolio

Yep. Might sprain their wrist opening the box.
Discme too
Cheers
Miner

[MAC]

Haha - definitely no.

Chairman will be questioned by a really pissed off shareholder about his 'tens of thousands' of tests comment.

I think they would get more out of a new pair of glasses

I don’t know Moosie, everybody has a unique way of analysing and some have more business exp than others to draw on. That now infamous quote, whether it was actually said or was not said;

“The Pennsylvania lab has the capacity to process 260,000 tests a year and Mr Swann is confident the company will processing ''several tens of thousands of tests'' next year.”

I’ve always interpreted that as this present calendar year, others may interpret it as sales to the FY15 financial year reporting. Either way we will not know if they have achieved what was published until May 2015 when the preliminary results are due.

If individuals anticipated 10,000+ sales to FY14 from such comments, then I guess firstly, they cannot read the words “next” and “tests”, and secondly they need to do more investment research, a company cannot substantively sell without first hiring a sales force.

My view is that 10,000+ tests is entirely probable by FY15, I would always as an investor hope that we get some numerical guidance from this AGM but don’t expect it for the same reasons as last year.

[Balance]

I think they would get more out of a new pair of glasses

This is on the record and uncorrected by Mr Swann or PEB to date :

"The Pennsylvania lab has the capacity to process 260,000 tests a year and Swann is confident the company will be processing "several tens of thousands of tests" during 2014."

http://www.nzherald.co.nz/business/n...ectid=11178639

Not 'next year' but '2014'.

[MAC]

This is on the record and uncorrected by Mr Swann or PEB to date :

"The Pennsylvania lab has the capacity to process 260,000 tests a year and Swann is confident the company will be processing "several tens of thousands of tests" during 2014."

http://www.nzherald.co.nz/business/n...ectid=11178639

Not 'next year' but '2014'.

Yep, and we should know in May 2015 at reporting time if he was right.

Companies don't generally provide YTD sales figures at AGM's, Pacific Edge won't either.

[nextbigthing]

How long does FDA approval typically take for this sort of product?

[Balance]

Yep, and we should know in May 2015 at reporting time if he was right.

Companies don't generally provide YTD sales figures at AGM's, Pacific Edge won't either.

As he made the comment without prompting and given Mr Chris Swann sold shares on the back of his comments, shareholders and the market are entitled to an update.