Lombard Medical Technologies Share Discussion Threads

[greynag] 28/2/2011 13:41

"The first three of these modules on biological testing, non-clinical laboratory studies, and sterilisation and packaging have been reviewed and accepted by the FDA. The fourth module on bench testing and shelf life has just been submitted and the Company remains on track to file the fifth module on manufacturing before the end of the year. The final module containing the clinical data is expected to be filed in the first half of 2011."
"FDA's objective is to complete the review of each module and issue a deficiency letter or an acceptance letter within 90 days of receipt of the module."

Fourth Module submitted – reported 22/11/10
Fifth Module submitted – reported 13/12/10

"You should provide the approximate timing of the submission of each PMA module in the PMA shell to FDA. It is FDA's intent that applicants who choose to participate in the PMA Modular Review Program would submit modules at intervals that will allow the agency enough time to review the module, provide feedback, and close out the module prior to the arrival of the next module. The one exception is the manufacturing module, which may be submitted without regard to the timing of submission of other module(s). In CDRH, the Office of Compliance is the primary reviewer of this module, while in CBER, both the Office of Biologics Quality and the product office review10 the manufacturing module."



Providing no discrepancies we could be close Final Module submission. Unless, of course, that the recent decline in share price is due to .... In which case, a little longer to wait.

[spekky] 28/2/2011 11:41

It would be good to get PMA Module 4 approved by FDA (as a post period event),then we are two thirds there.Obviously mod 6 is the key but this has not even been submitted yet and will take a long time still.I think 2012 is the key year here.Not sure if they can submit 6 without first having 4 and 5 approved.Would not seem logical if they could.

[webshares] 24/2/2011 18:51

well eoy results in mid march and at any point the final submission to fda could get this moving again.

[flyfisher09] 24/2/2011 18:46

Been walked down on no news I reckon.

[roundyg] 24/2/2011 17:36

This looks stark guys, unfortunately LMT continues to dissappoint. I have been here since 2003 (Lombard -> LMT, delisting, relisting, etc...) and will remain with the hope that we might someday regain some loses.
Anyone of the mind that it is worth further punting or is information leaking with respect to some problem with the FDA submission?
Fingers remain crossed!

[flyfisher09] 24/2/2011 17:31

And me, been in for 2 years.

[balcony] 24/2/2011 17:14

Also here for the long game

[webshares] 24/2/2011 17:12

haha good, we were getting lonely

[stable] 24/2/2011 17:09

Webshares

You two are not alone

[webshares] 24/2/2011 16:11

well lets see what the results in a couple of weeks time gives us? will give me a better picture of what to expect over the next few months.

i think me and you nod are the only people looking at this share right now ha

[nod] 23/2/2011 21:34

on the positive side, we might get another chance to top up below 1.3
possibly the last time if all goes to plan this year

[webshares] 23/2/2011 17:11

shame i thought we had found a new base.... risky shares have all taken a hit in the last couple of days

[nod] 23/2/2011 08:59

here we are on the 1.6 support level. unfortunately, markets are looking fairly glum. there has been very little selling recently in LMT but with few buyers around it doesn't take much selling to blow it off the ledge.

[webshares] 12/2/2011 20:39

we had to back test 1.6 before the next breakout it would seem. glad it held. now onwards and upwards it would seem. results in march. potentially fda approval soonish. i'll be loading up here in the next few months if signs are good.

[nod] 04/2/2011 10:18

head and shoulders

and a bit of dandruff

when everything was falling yesterday LMT was holding steady. no sign of weak holders :)

[webshares] 31/1/2011 18:49

me to stable. this is a long term hold for me so any fluctuations until news doesn't make any difference to me. results in march, hopefully we get the next module out before then. after that we have to look forward to fda approval, if we get that who knows lmt may not exist by the end of 2011

[stable] 31/1/2011 17:19

I believe it is much more difficult to have a fair view of any market when the twisted MM's play the small pi with the plus market.
1.94m traded on plus today, when trades were going on within the main market at1.7 there was a 437k trade on plus at 1.63. The market price at close was 1.4 to 1.8 on plus These are the same mm who are trading on the main with a much tighter spread and they are manipulating the market as they know that not many PI are following plus. I might be proven wrong but I believe Wins is a major user of Plus and he was also the leader on the sell side early today.
Todays fall did not have panic volumes, I think someone did want to sell and with no news it was difficult to find buyers until we hit 1.55/160
I will continue to keep the drawer locked until I have news one way or other

[webshares] 31/1/2011 16:06

back to 1.6 it was then. but where now. would be a huge shame if we drift down again

[balcony] 31/1/2011 11:25

think they may have been sold down due to the bad news on ASM although this is a different story completely.

[rayrac] 31/1/2011 11:16

Probably more sells than buys? Although it doesn't appear that way on advfn.

If a share doesn't move enough, then the mm's will do it anyway, just to create interest and hence turnover/cash for them.

We have to wait for the real deal!

[flyfisher09] 31/1/2011 09:55

what's caused the drop today?

[nod] 27/1/2011 01:37

waiting for his salary to clear

[webshares] 26/1/2011 17:22

maybe the buyer will be back in feb, reached his limit for this month

[nod] 25/1/2011 21:22

a retrace on low volume is okay - shows there is not much selling

[webshares] 25/1/2011 17:51

back to 1.6 or will there be a little surprise by the end of the week