Member Info for spike912

Because the FDA’s minutes are the official records of meetings, the FDA’s documentation of 562 meeting outcomes, agreements, disagreements, and action items is critical to ensuring that this 563 information is preserved for meeting attendees and future reference. The FDA will issue the 564 official, finalized minutes to the requester within 30 calendar days after the meeting. From FDA website “Within” 30 calendar days...not “after” Update now required imo

Tiburn totally agree with you. However you’d think someone of Seftons ability and experience would have learnt by now not to quote specific or tight time frames as the market and investors will naturally hang him on missed deadlines He should know to keep stum or over cook timelines ie he should have said Q3, or H2. Then if it delivers early he’s seen as the man that over delivers He makes a rod for his own back which sadly is being reflected in the share price. Without news tomorrow I can see this into the 8s :(

I’d be more than happy raising at 50p plus to go commercial with a billion pound company...wouldn’t you? JV, loan...all open and non dilutive when you have an approved drug! Why do people always associate equity raises with big dilution

All I know is another 250k but has gone through, so that’s not punt money, as was the 450k yesterday but ultimately we are all speculating at this stage

There are plenty of ways to raise cash which aren’t all dilutive, but it will depend on your assets But by that point you’d like to think we would be a lot higher than we are now and we would have a sound investment platform with shareholder value being witnessed. The issues will come with a raise off the back non approval I must say I thought we would have heard now. They may not have had the minutes, but it may also be they have gone back to fda for clarity on something before issuing to the market You can’t read anything into a webcast imo as nothing was given away at all

Wouldn’t take his word as gospel lol. I don’t think he understands the concept of dates and times lol

Ouch two large 5.3mil sells gone through

It’s CALENDAR days! Not business! I posted the link from FDA earlier and the wording

Scott imo your reading into things that aren’t there and making a very big leap of faith. It could be as simple as the website being updated, a system error anything. At the end of the day the interview gives nothing market sensitive away, nothing at all, in fact I would go as far as staying it’s pretty dull and nothing new, with many politician answers. So the fact it was there, not there, now there, makes no odds whatsoever For all we know, they may not even have the minutes yet!

I think the best part of the interview is the clown at the end of the interview about market manipulation haha, until they cut him off. I think they have to be careful now saying on at least two occasions not no further trials needed, but then saying extra “data needed”. If it now comes out another trial is needed confidence in our bod would be shot to pieces. Which is why I think approval and post approval data is the way forward

Scott has bipolar don’t you know ;-)

Bear in mind this was before the type A meeting so personally I’m not taking too much from it as things could have changed since or at the meeting

I did email Sefton last week but no reply received back

Chances it’s not moved as amp sell in background imo

Liquid lol it’s hardly moving up, on a handful of trades. Chill ;)

Liquid good question but imo the only fair way to issue news is when both markets are closed hence I believe it would be 7am in line with initial CRL news

Four. See https://www.fda.gov/media/109951/download Because the FDA’s minutes are the official records of meetings, the FDA’s documentation of meeting outcomes, agreements, disagreements, and action items is critical to ensuring that this information is preserved for meeting attendees and future reference. The FDA will issue the official, finalized minutes to the requester within 30 calendar days after the meeting.

Nope! It’s one calendar month for issue, which was Sunday 2nd June. I would say they will then use the 3 day to issue price sensitive news to review, and expect a release Wednesday/Thursday It may have landed as last minute as yesterday for we know Personally can’t see any other time to release bar a 7am to keep month markets consistent

Can’t see any benefit after hours on both. Better of a 7am IMO Would be nice to sleep on good news tho haha

I will be interesting to see the minutes. The one thing that has always stuck in my mind is option one being labeling with additional wording. But lunsden also said extra data is likely to be required. So by virtue of that option 1 seems a non starter imo, as you wouldn’t need extra data for that. Option two post approval monitoring makes sense and option 3 seems unlikely given the current data and enzymes levels that went with it and the substantial evidence on liver toxicity If I was a betting man I would be putting my money on option 2