focusIR May 2024 Investor Webinar: Blue Whale, Kavango, Taseko Mines & CQS Natural Resources. Catch up with the webinar here.
Thank you fastmoney really appreciate your post :)
Some further discussions on the mtfb forum to help understand what may be the situation that caused all this, quote below.
In the clinical protocol for the Phase 3 it states:
"No formal statistical analysis of the safety data will be performed"
Could it be that the FDA wants to see the actual analysis that iclaprim is statistically safer than vancomycin? I believe the company only provided descriptive stats. Maybe this wasn't enough for the FDA?
Lets refocus and I apologies for reposting my original message which is actually my first message here.
I just wanted to run this by more experienced people than myself regarding amp In all the noise we have not talked about the 7th feb rns where the company (amp) halted the rise in share price due to momentum
'confirms that it is not aware of any specific reason for this movement.'
this makes me wonder if they could possibly have known about the fda staff shortage or that mtfb were considering a clean label or some other reason, just something to ponder, there could be many reasons for that which more experienced people than myself would consider?
relax guys we all want the same results, we should use our energy to good use and try to figure things out. Tensions are going to be high as we have had a shocking crash without good reason! Play nice :)
Kettle, I have been very transparent, it is radio silence on amp and I would like to talk about my investment which is down considerably and I was left feeling very upset about it! A forum is to have open discussions and I am trying to have exactly that. I don't see why I shouldn't quote mtfb comments onto amp if those comments help people like me, and amp is linked to mtfb success. If I am trying to cheer up spirits and offer some hope to people like myself who have lost out with relevant comments then I see no foul play with that as you are insinuating!
Thank you Tobias very much appreciate your input. :)
I just wanted to run this by more experienced people than myself regarding amp In all the noise we have not talked about the 7th feb rns where the company (amp) halted the rise in share price due to momentum
'confirms that it is not aware of any specific reason for this movement.'
this makes me wonder if they could possibly have known about the fda staff shortage or that mtfb were considering a clean label or some other reason, just something to ponder, there could be many reasons for that which more experienced people than myself would consider?
In all the noise we have not talked about the 7th feb rns where the company halted the rise due to momentum 'confirms that it is not aware of any specific reason for this movement.' this makes me wonder if they could possibly have known about the fda staff shortage or that mtfb were considering a clean label or some other reason, just something to ponder, there could be many reasons for that which more experienced people than myself would consider?
It feels good to have open discussions and consider what may or may not be. I think it is better than radio silence, below another quote from people who are smarter and more experienced than myself which makes me feel more positive. I also feel we are in uncertain times and the market in general isn't very positive with regards to news flow.
Approx 588 of 600 patients in iclaprim group had no liver tox issues, 12 had raised liver enzymes, asp/alt. Of those 12 all returned to normal after dosage with no liver damage.
Approx 591 in vanc group had no liver tox issues, 9 had the same elevated enzymes, ast/alt as Iclaprim.
600 patients out of 600 in the iclaprim group had zero kidney issues.
593 patients in vanc group had no kidney issues, 7 sustained kidney injury from Vanc dosage.
Zero patients died in Iclaprim group
3 died in the vancomycin group
Which looks the safer drug? I expect a re-label to monitor patients with raised liver enzymes.
The USP targetting renal injury patients is still intact.
These are the points that make me feel there may be light at the end of the tunnel, we just have to wait and see what will happen. Another quote
It does make you wonder about the 3 month fda shutdown and the fda running on a skeletal staff for 90 out of the 180 days allotted to the review..
Could they spare staff/time for adcom meetings, or is it easier to stall the approval and by some time until they get back to full strength? - not sure we will ever know the truth but if that is the senario they have caused some serious damage here.
Another quote which makes me feel with time it will reverse because we were not rejected just asked for more data.
The mcap was £130m a couple of weeks ago before the FDA said they require some more data on liver enzymes. If approval had been given it would have doubled as a starter. Now just £21m mcap
I have studied the Phase 3 results to bloody death and discussed them even more with pharma investors, i just cant see how they cant approve it , with or without a label to monitor liver enzymes the world needs this drug.
A lot of ground to claw back but this is a billion dollar drug once approved. (If)
Indeed that has been said and I do appreciate your comment thank you and that is why I have said it is wise to wait and see, but nothing has changed in the past fortnight other than the clr being issued and the share price here gained momentum and rose up to 2p with the same fundamentals on 13th feb. Good news inevitably brings in momentum and that inevitably means rises in share price. Nobody would have predicted the rise here when mtfb was 40p but it happened. Nobody can really claim it wont happen again, and nobody knows about the approval. Below is another quote from a more experienced poster than myself which makes me feel hopeful.
Pretty clear they will need more cash in the next couple of months. How much depends on what requirements the fda have. Funding will come after the type A meeting imo, though im already hearing a strong rumours of whats going on backstage but rumours are just that until proved.
Best case senario for me is re-submission of NDA with amendments and data required by FDA. As per the conference call - unlike in the aripida CRl the fda have not stated any further clinical trials are required.
Once known a small raise to cover costs of NDA and overheads for 4 months. Then wait for approval and if given the mcap will be over £150mil at the bottom end.
Will they then need to raise again or at that stage will "interested parties" step in.
Tough times at the moment for us long term holders whilst traders make hay.. I take solice in the fact apart from the initial panic sell and stop loss crash, the ii,s have since held. No sells from sandgrove, M&g, with Invesco still holding 14% etc.. 100% GL will have met with and spoken to them all and discussed the way forward.
What happens in mtfb has an impact on our share price because we are invested. Here is another quote from an experienced poster which I believe is useful.
I take solice in the fact apart from the initial panic sell and stop loss crash, the ii,s have since held. No sells from sandgrove, M&g, with Invesco still holding 14% etc.. 100% GL will have met with and spoken to them all and discussed the way forward.
Its not a case of wrong labelling, opinion is Motif may have wanted a clean fda pass with no side effect warnings.
A label issue means approval with possible side effect warning on the label - what drug doesnt have that.
Below is a quote from an experienced poster on mtfb, I think it is a good idea to keep an open mind. It is useful to wait and see.
All you can do is look at what info you have.
1) additional data. It passed 2 Phase 3 trials that had FDA input in tailoring and was the same as an approved drug on liver tox .
These are facts and and you’d still invest on that basis the day before d day ( and kidneys 7-0 to MTFB )
2) a 5 pc holder puts the whole lot up on the ask on opening , not drip feed, no worked order and the auction was 75pc higher 1 second before trading opened. Who then dragged another 10 pc of a long term and witch in turn triggered 50 m of stop losses.
If anyone has seen or anticipated all of this before, let me know. Even the biggest derampers assumed approval was a given
Watch and wait imo.
I think it is important to see the bigger picture. I am certainly going to hold until we get past this bump in the road, even though I am heavily down as share prices can be unpredictable. There can be things going on in the background that ordinary people will not even dream up because we think differently. Lets not lose sight of what we really have here. Both shares here and in mtfb are wanted! Therefore I am going to ride the storm and the tree shakes. Let us see what will happens.