Member Info for n4apenny

CFP... its there in the historical content somewhere, but this was also confirmed yesterday to me by Walbrook. Sorry can't be more specifc

I was reminded yesterday that the BoD fully believed that they would get a tick in the box at the recent FDA review. One of the key reasons for this was that MTFB engaged 3 experienced independent US-based liver experts to verify and validate phase 3 trial results. They - the experts - clearly did NOT see anything in the trials which highlighted any worrying liver toxicity concerns or anomalies. Many of us on this board have undertaken some sterling work to also look for clues as to FDA concerns, but with a degree of unanimity have not been able to find anything of substance in the data available to believe that iclamprim falls outwith acceptable boundaries.

The BoD has done its due diligence from a science perspective. This is a matter of interpretation and understanding.

This of course does not lessen any of the pain, that especially LTHs are currently feeling, but if you believe that the science will win out, then approval should be forthcoming sooner rather than later - perhaps with labelling changes.

Of course, this does not minimise other challenges, especially around financing. IMO, the BoD remain confident that they will get approval, and with this in mind will not raise finances until post FDA agreement, when the raise will be against a much more reasonable SP. Until then, in the current information vacumn we will have to be strong and sit tight or look to trade.

One final thing,'radio silence' is one thing, but I remain very unhappy about the level and quality of comms coming out of the company which has, IMO, been close to atrocious. Sentiment and perspective are important, maybe not quite as important as getting this across the line,but one reason for the current SP is the appalling lack of positive messaging coming out from the board. They may not want to p*ss off the FDA, but surely affirming one's confidence in the drug, and its trials, and a formalised plan of action to respond would not have gone amiss.

GLA and stay strong

... any buy volume building up?

Tobias... Can you provide the link please!!

Ivy... thanks for speedy response and clarification. I was thinking about the overall cost of treatment but didn't set it out as such.
Post market surveillance is obviously key here, and I would expect some pretty stringent conditions to be set up, until a much clearer picture is established regarding elevated ALT levels. From what I've been able to glean, the benefits appears to signficantly outweigh the risks which is why, financials concerns notwithstanding, I'm of the opinion that it will gain approval, but not without causing me - and others - some significant stress and anxiety along the journey.

GLA

Good morning all... been away a while, and have been interested to pick up the activity around TE-10. Whilst it been announced as a discovery, what is the likelihood of it being commercial? It feels as tho' the team and Schlumberger are working very hard to ensure it is so? Whats the vibe here about it?

Not deramping, just still bruised from ECHO

...been away... why the significant SP drop?

Morning all. Some really interesting posts yesterday.

Vascular, as a layperson, I find it really difficult to interpret the output results from the trials, but as I see it it from abusiness case "strengths" perspective

Kidney impact - signficantly better than "v"
Liver impact - equivalent , no significant different to 'v'
Cost - signficant cheaper per course
Important other - is able to attack MRSA's more effectively.
Opportunities to address other illnesses such as Cystic Fibrosis.

Can our more learned colleagues on this site dress this up more succintly or correct any misinterpretation.

N4P

.... I think I'll avoid looking on here, at least until after Post Type A meeting, when we hopefully wil be able to add a '0' to the SP, and that's 60p not 0.6p!!!

Jimzi... I agree. I also agreed with your comments the other day regarding sentiment and perception, both of which are incredibly important. Even if they themselves, don't get IC over the line, they do influence SP. I think being in this current news vacumn is just about the most uncomfortable place I have ever been.

That said, in some way, I am comforted by the fact that they haven't already re-financed. Perhaps my confidence is misplaced, but I'm hoping that BoD are confident that they can turn this around short term, and won't be financing until the SP has recovered to a degree - everything is relative I know.

GLA

apologies FM, what question?

...this may well be the case, but then why no "AdComm", the signals appears to be all green, so why at the last minute did they turn "red". Makes no sense to me. I hope that this remains resolvable, and in the short term, but as with all others, apart from maybe a handful of folk in the FDA, I don't know what it is that we trying to resolve. Oh, and as for the FDA bemoaning the lack of effective new drugs to counter MRSA,etc, well don't get me started on that!

GLA, "remember its darkest just before dawn!"

... Morning all. Was wondering when the next MTFB communique will be - guessing its post FDA meeting, but when will that be - normally 30-45 days from receipt of request - but of course might be quicker. What happens in the meantime? Do MTFB and FDA actually talk to each other to discuss the concern or not?

DrS... on this i disagree to a point. The IP itself should be worth a considerable slug of money, remembering that Iclaprim has passed P3 trials with apparently a lack of elevated side effects;liver and kidney - despite what the CRL says. So what is the IP worth?

Ivy... I agree that this is likely. Based upon what we know, my heart and mind both say that this will end positively, however I also thought that a couple of weeks ago. Sometimes I just need to stiffen my backbone with some 'wise words' from others who have greater insight than I into the technical aspects of this process.
Keep up the good work!

DRS... I must admit to concern that little is actually known or indicated by the BoD about how they are going to 'apply laser-like' focus to their cost base. It may not be true, but I have a perception that BoD has treated its PI's with a degree of contempt since the FDA decision was announced. Despite the undoubted shock of the CRL result (interim) I feel that they could have been more effective in their communications, build confidence and rebuild trust.

Getting back to my original questions regarding next steps insofar as the FDA is concerned. Will the Board adopt a 'radio silence' approach until after the FDA meeting?

Yes, some reassurance is needed. Its "ok" to believe in the science, and that is probably what 99% of us did for the original application, but positive signals from either BoD or the market (IIs) would be most welcome.

Reasons behind the question are that a) the Type A request should have been made over a week ago, b) might informal discussions have taken place that might have better framed the precise nature of the concern, but that the company wishes to parcel up as part of Type A meeting RNS outcomes given the high level of confidence (fingers really crossed on this point) that the concerns are relateively minor - given that all communications at this juncture are being tightly managed.
Alternatively this might just of course be my naivety

... is the company obliged to issue an RNS to inform that they have requested a meeting with the FDA, and then subsequently inform the market when that meeting is scheduled for?

Also, will there be ongoing discussions during the interim period to nail down the precise needs for the meeting, or will all this be left until the meeting itself - which, IMO, if that is the case, feels an entirely antiquated and bureaucratic means to approach this or similar situations....

Thoughts...???

PR.. also my fervent hope!