Member Info for Jimmybob

Sorry to say it but you don’t get it. What you are suggesting defies logic. So you are stating the the company are telling porkies and they know the outcome? They would have to RNS that as soon as they know. The whole stock market is based on these premises, why do you think Mtfb could get away with not relaying the information to its shareholders. Find me examples where companies declare the outcome of these meetings the day of the meeting? Everyone else must do it according to you so prove it?? JB

And your point is??? 3 options/paths forward were defined in the meeting, the final result of which will be conveyed in the meeting minutes/response letter. This is their protocol you don’t go to the meeting and get a decision there and then. The panel discuss and debates their views after the company representatives have left and have 30 days to do so. If not why don’t they just hand the decision over. You misunderstand the process. I have been there this is how it works unfortunately. Ps could well be longer or shorter than 30 days that’s general guidance!

They cannot announce they don’t have the minutes or the direction from the FDA. They do not know yet! JB

You really don’t know how these meetings work! They will not have a clue of the path until the minutes are issued. You are the one in need of research? JB

Very well put to you both there and many many routes this could take from to do a study or generate new data. JB

Are you also a self harmer? For someone who is invested you are very negative, anyone would think you want this to fail;-). JB

Data and study don’t always mean a clinical trial. Please try and educate yourselves a little, or are you trying to scare people here out of their investment? JB

Mystic meg you are so so clever and insightful, wish we all had your crystal ball! Does it ever see anything positive or just predict doom and gloom? When is the world going to end? JB

I don’t see it that is not binary or we would have already have a no from the Agency. I think we are more likely than ever to launch this product and the risk has been significantly reduced. When we get the minutes the company will know exactly what they need to do to gain approval or may even have the go ahead to market the product with a label warning which is no major issue. Post market surveillance is standard practice so a post market registry or study is no additional burden anyway. JB

Surely he must be prime to go to comedy?

Yes the world is over we are all doomed! Sp250 predictions are all coming ture!

Only needs to 10 bag from here for me to get money back! JB

You mystic meg?

You got to had it to SP 250 he must be putting a lot of effort into looking for these seeds of doubt and then putting a lot of thought into strategies to spin them on here to cause fear. The issue I have with his approach is that he only ever emphasises the down side risk no matter how small and probable. He completely dismissed or ignores any positive news and upside risk reduction/progress to market. Let’s look where we are now. 3 clear options to approval defined with the Agency (no approval not being one of those!), which do have different risk, cost and time profiles. The worst of which; more pre-market data, may actually be a relatively small cohort, short study addressing this liver risk for all we know? My view is we are close and have derisked further since the original NDA submission. Our chance of success of getting to market has increased substantially and our Net Present Value has actually increased! But unfortunately this is not widely understood and hence the languishing share price. Let’s hope for clear decision next week and hopefully that approval we and our patients deserve! Good luck all, including SP 250 (include a tight stop on that short;-)). JB

I agree about the value Partridge let’s hope it can be realised, this 3 shots at goal approach was certainly risky hindsight is a great thing as they say! I think we should north of 50p which most would accept now. JB

Just a thought perhaps the Agency have asked us to rerun the analysis on the liver function data with these patients excluded? JB

I know was just a bit of bait trying to hook our troll;-). It’s an interesting point though, if the FDA were fully aligned to the protocol there should have been agreed success criteria that we believe we have met. Something has come up that was unanticipated? Let’s hope it easy to address, it maybe as easy as the patient population being predisposed having compromised liver function prior to enrolment as ivy has already highlighted? JB

Great news if agreed up front with the Agency then I don’t see how they can go back on what was agreed! Approval seems to be coming? JB

There is dialog, but it’s mainly you presenting data on safety and efficacy and answering a barrage of questions from a panel of poker faced assessors. You don’t really get much steer on the overall outcome until you get the official response. Just because you got a hard time or they dig into specific issues doesn’t necessarily mean there will be a bad outcome or vice-versa. JB

I have presented at these meetings. MTFB will have no idea of the outcome until the official response is received. As Ivy correctly states the jury is still out and the result undecided until the response is received. The Agency has strict protocol which has to be followed. JB