Member Info for ColdFishPie

I presume thats a bit of thursday banter from you daz, maybe your team won last night to put you in such a jovial mood:) You would have to say that given the lack of comms on it...the southern contract is in serious doubt of being down the toilet and adam is furiously out with the begging bowl to the major investors again. Im really not sure if theres a way for amc to get out of this mess...hope the big boys dont mind chasing losses.

Seems like the fda approved linezold in the early 2000's. Yes, that was the main highlight but they also have liver tox.

Thanks ivy, Yes, reading linezold wiki page it states that a medical team in australia have developed a process that includes regular liver testing and it also states that there is raised teansaminases with linezold also. I presume its a lot lower and why mtfb have not included it in their table. I would take a black box warning!

A quick read of the linezold wiki page makes for interesting reading.....

Ivy, I also have a question please:) Have you seen the linezold liver results or the other 2 ab's that failed at the same time as ic but now passed...have you see their liver tox results?

Yes, it was referred to yesterday and was confirmed.....the i.p. is not included, same as before. There was some good questions asked...just not the couple that i wanted but in general, i think they answered most questions adequately. Bear in mind....they had to be tactful reference the fda questions but on their guard reference market reaction so as much as i expected given the circumstances. Its crazy when you think about it...real cloak and dagger stuff seems very apt!

Hi Ian, Good summary and thanks for posting. Given the minor difference, especially on the pooled data and the fact that nobody died or had any liver failure/complications, its almost unthinkable that the fda would not approve iclaprim. I'm sure there is some further detail thats not in the public domain but would it change anything? It does not sound like it can be anything adverse or not consistent to the performance against vanc with the public domain stuff and given that iclaprim performs better than vanc and linz in all other outcomes...seems very unusual. You never know, this could be very straight forward. Provide the additional data because we need the finite detail on record to allow approval. No wonder they are baffled by the crl but then again, the fda sets the criteria and they want to be sure so we will just have to wait and see. Surely, its not in their thinking to not approve it because there's not a big enough benefit in terms of efficacy against vanc? I wonder if theres something left field within the fda thinking like the approval of iclaprim could speed up the resistance against vanc? Or, do they view iclaprim as an important drug but its just not needed at this point and they will approve it at a later stage when they best think it will serve its most useful purpose?

Ivy, agreed....would be nice to hear of some cost cutting measures in the interim but stiff upper lip for time being.

Two stand outs for me.. Firstly, good to hear that the balance loan is not secured against the i.p. And confirmation of the % base with liver tox is low as stated. I wish someone had asked a question re labelling because this could be important going forwards and it would have been good to hear their thoughts on it. All in all, much as expected and good that they will update straight after fda meeting...plenty to play for.

Mind you....i made a mistake there. Even if elon musk never wanted dms, they will have to by regulation soon so maybe thats why he will come our way.

Yes, i agree but its the statement that tesla signing would make. All along, mr musk has stated no DMS then these accidents in the last 18 months have pushed them, i think beefcake thought it might have been a tesla they were working on when he visited see so im ever hopeful....the market would go crazy if it was them, you would never see under 15 again imo.

Even although fca is the 8th largest carmaker in the world. I would prefer if it was tesla....it will be all over if they ever sign up. See could name their takeover price!

It was me that done it, mentioning my 30p target:) So, how come they are doing so well in the u.s. then...what gives?

N4...very bad night. You can rule that out...not even the big boys would dare take on the fda. At the end of the day, they are there to review, access and approve. If their assessment states that the drug might do more harm than good...then thats it, no court in the land would go against them...and for by that, it would cost 100's of m to go there.

Well thought out johnny and hope you are right. When you don't know anything and the crl comes as a shock, its easy to think the worst. Ofcourse, the bod will know whats to be done but really hoping they can nail this during the fda meeting....they dont give you long for a meeting, do they:)

Will they (fda) considering reducing the labelling at that point...should have said. They have done this with other approvals before.

Jimzi, I have not brought that up but i think that is the most important question for the cc. Given ivy's post relating to this liver toxi might...and i say/he say might...only effect 2% i think its most important to ask... Does it only effect 2%, if thats the case...when you supply the additional data and if they were still not happy...will the consider reducing the labelling at that point to account for the 2%. I really hope it is only 2% and if that were the case i think mtfb should forfiet it. Thats too me is the most important thing i want to hear answered during the cc. What do you think?

Im not interested in zero, had plenty of dark days but would take thirty now thanks:) Whats jack doing...c'mon man, at least let us know we are moving full steam ahead now!

Missthepenny...thats true, all made a bad mistake in being to confident of approval. There was mitigating factors to this ofcourse. The previous failures now been approved, the company contact with the fda through the process, the posters showing beneficial benefits against van and last but not least....no add comm which was the biggest factor for me. All of that said....we made a mistake and gambled against it but its a debatable point wether the company should have done. With hindsight and its easy with hindsight i know, but they should have made sure they had enough money to cover the debt and a bit of working capital for there after. The position now is much more difficult to manage and this puts all at a lot more risk. The problem there is that bod's can just walk away onto their next project...yes, they lose their options but big deal, thats like you losing a bonus at work. It might have potentially been a lot of money for them but its not going to effect their mortgage payments or retirement that much....not like us! Hoping graham has got a good strategy for coming out of this but we are in the lap of the gods now......if mtfb have made a mistake or tried to wing one then we up up some creek in the back of beyond...if you know where i mean:)

Napenny....that debt was the first thing they needed to focus on and this mornings news helps. Now lets see what the week brings...cc should be good.