Member Info for PrivateRyan

odd the so called trolls hold through adversity in significant amounts - whilst the rampers disappear over the horizon ......
glad you are still on board OS

This is a perfect storm- forced seller ie AMP -and in a company which has said it needs to raise funds in the near term. And it is out of MTFBs control until they know what the FDA want .So in those extreme conditions I think the share price is going one way and that is not up.However it may at least stop the share price slide(which is important as it could determine how much we cede in terms of equity dilution) if we can get a feel for the timescale for more knowledge on the importance of the issue.At the moment we do not even know if a meeting has been arranged(the deadlines for FDA are gidance as far as know and sometimes are not followed strictly). I think that should be announced .If t is imminent hen maybe he equity raise can be minimised.And then following that meeting a caveated feedback should be immediately released -ie dont waiit for FDA minutes. Time is of the essence in this storm and I believe Graham has not dealt with this well.

The truth hurts lol!

thanks birdseye- very helpful- lets hope its class1 !

you may be right Tobias. But wouldnt it have been good if motif could have explained the process on that conference call rather than us poor sods having to scrabble around to figure it out . I have been watching thiss board and dont recall anything about two months - hope you are right-maybe one of the techies knows for sure

https://www.drugs.com/history/orilissa.html

This seems to show the FDA can approve an NDA in 3 months or so . Maybe a ray of hope ......

yes jimzi- a lot of the ones i glanced had a long list of potential dangers
hard to believe we are in this position particuarly as the potential toxicity seems to have been addressed in the testing as far as I can remember- the dosage was 40 mg for liver impaired patients?

https://www.drugs.com/history/xyosted.html

another example

both were approved by the way in the end

Just in case anyone was wondering i dont think this is going to be a swift process.See an example I found in the attached link.It seems to indicate a new NDA will need to be filed and that then starts another six months for FDA to approve - so we are probably looking at another year before approval arrives?

https://www.drugs.com/history/dsuvia.html

you have jinxed it taken over from ps68 lol

For the record again true tax losses are virtually unusable so forget that. I was a tax professional
I hope we get a meeting announced that is soon .I hope the outcome is we do not need to do much more. That will mean we do not have to raise capital at 7 p rather than eg 20 p Nite all

We had the apple link a couple of years ago.. the the Samsung pen .... Same old same old. Hopefully real news is coming in the interims. We know the potential but we always have. We need to fulfill it

ahhh so that is how TT was so confident! no inside track then- thanks cj

the important stuff will be in the outlook staement

Cobblers

ahhh-the true test of being in the know- or a b s - we will see

Well they did clearly say they were surprised not to get approval so I think that is a clear indication they thought the liver side was dealt with and acceptable. The Vimeo video was a great find. It does show a different approach to damaged liver patients was needed and it appears that was agreed with fda so in my view this isn’t a question of something being overlooked more that the supporting evidence needs to be presented That is my fervent hope .....

what a stonker
or is that stinker
not the rns I wa shoping for lol

sorry to be testy but there will be many of these over the next 18 months -they mean nothing

And.....? Big deal

tobias i would have expected that the date of a meeting with FDA will be announced as soon as it is fixed.It will be very important to reduce the perception of the need for funding before the meeting .And then if FDA feedback is acceptable (eg no further costly trials)the share price will rise and the funding can take place on more beneficial terms.ie less dilution