Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
(Going to keep going on this live stream anyway)
-Bloke asked whether they could do RAMPS (??? - monitoring toxicity after approval?) or have a labelling change. No direct response from GL.
-Oral formulation gave much higher toxicity in the liver. This and delay of toxicity was a problem.
-No idea of timeline
-No idea of next FDA meeting date
You thought the f***wits would have asked what was required of them by the FDA at the CRL follow up meeting. This isn't a game of "guess who". If the minutes don't say exactly what is required, what will? How many more meetings?
joshing_man, totally agree with you by the way.
You thought the f***wits would have asked what was required of them by the FDA at the CRL follow up meeting. This isn't a game of "guess who". If the minutes don't say exactly what is required, what will? How many more meetings? Sorry, just rather angry.
I am now out of this stock.
Why?
He said:
1) He didn't know what data the FDA needed except that it is "liver and other data".
2) They have to arrange a meeting with the FDA and present what they think the FDA need.
See a problem with the above? MTFB are engaging in guesswork regarding what data the FDA need. How can they present a trial to the FDA if they don't know what is required. This will to and fro for ages IMHO. God knows who bought my shares...
Might get in again later, but I'm out for now with a nasty hit to my portfolio. Yay.
At the start of the call:
-have enough cash to keep going till September
-but then he said something about fundraising (after September???)
-Need yet another follow up meeting with FDA
-New trials will be a few weeks longer to take into account the delayed toxicity results
So far:
-GL has no idea what the FDA want except that it is probably liver *and other* data
-There was an issue with a delayed increase in liver toxicity enzymes 2-3 weeks after the trial finished
Filter him. Click on "Filters" and add in his username.
Well put. It is time for straight answers. He has all the information he needs from the FDA. Now bloody well tell us!
The optimist in me is saying the same as you; that we are now fully informed of what evidence we need to provide *** and how strong the evidence must be ***. Before today, we did not have this information. This is certainly a derisk, if you believe that the drug works as well in the follow up trials as it already has done.
On this point, I want to know from GL in his honest opinion if there is an element of bias from the FDA. i.e. are they being dicks.
I suppose he would never give his frank opinion on this though. :-/
This was always an option for me. The option I feared most was the "you have no chance, f*** off" option which is what could have happened. Okay I paraphrase a bit but you get the idea.
I went over the data and really cannot see a difference (only a positive for the kidney stuff) between iclaprim and vancomycin. The big question is given more trials and assuming the liver data is the same as that already produced in previous trials, will the FDA approve us? To put it bluntly, will they keep stroking our c*** or will they bring us off?
I am ****ed off with Lumsden right now as he loves to state in RNSs that they are "working closely" with the FDA. So much for that!!!
Soooooo...... anyone got any good jokes then?
Bloody FDA! First they CRL us for the government shutdown, then they delay delay the CRL meeting minutes.
Reminds me of most of the women I date. :-/
There is no longer a risk of salmonella in eggs:
https://www.bbc.co.uk/news/health-41568998
You included mate!
It really is mental. Blatently obvious RNS comes out. Share rockets then back to normal as nothing new has happened.
Massive spread. Everyone is holding tight now. As Braveheart said, HOOOLLDDD!!!!
RBK, what happens when one person owns 25% of the company?
Bloody AMP. Was there ever a bigger bunch of f***wits? They have a legendary ability to sell large tracts of MTFB shares just before massive ramps (okay, maybe just that one time).
PrivateRyan, that is not possible as there are not literally 3 precise and well defined possibilities, but rather a broad spectrum that covers the 3 possibilities.
With the CRL follow up meeting RNS, that was easy to create as all it said was "the follow up meeting happened". There were no details to respond to.