Cobus Loots, CEO of Pan African Resources, on delivering sector-leading returns for shareholders. Watch the video here.
You're braver than I am!
Rugs, I'm in the same boat. I essentially came to terms with the loss back in February when we got the CRL. I maintained a shred of hope that a new trial wouldn't be needed but then that was dashed. Since we found out another trial was on the cards, I chalked this one up to a loss mentally. But, as you say, absolutely no point selling for £100.
Just when you think it has bottomed out, we get new lows! Seriously considering a punt at these prices to get my average down. But given the setback in Feb and most recently the disappointing minutes, I'm too nervous to pull the trigger!
I'm currently sitting on around a 90% loss, having bought in at mid-30s. Yes, we know what is needed to gain approval but there is still the very real risk that the next trial produces similarly unfavorable results with regard to liver toxicity. What then? For this reason I am hesitant to invest more in an effort to average down.
Except for the CRL which came at 7am on 14th Feb..
As irritating as posters like SP250 are, don't forget that we all dismissed Petch's barrage of negativity prior to the Feb "approval" date as pure de-ramping and outlandish pessimism and yet he was right in the end. I'm a LTH who is currently >75% down so fully committed here but I will not be getting caught up in the equally far-fetched optimism of some on this board.
I'm Hoping for just a labeling change or a phase 4 trial (or combination of the two), but I would be surprised if we see a rise in excess of the 40p we reached back in Feb. Hope I'm wrong and we surge to new highs, but I think we should all remain grounded.
I agree, jarljib. The fact that the FDA had already raised issues surrounding liver toxicity prior to the CRL and MTFB was unable to alleviate their concerns or provide the necessary data is of considerable concern to me.
Some very sobering reading/viewing here: https://www.bmj.com/content/350/bmj.h2758
A study of 61 CRL was carried out. I've just picked out some of the top line results from the video (well worth a watch by the way):
- 87% of the drugs which received a CRL did so because of safety or effectiveness deficiencies, i.e substantial issues.
- He doesn't specify what proportion, but says new trials were 'frequently' required
- Only 49% of the drugs which required further trials following a CRL actually included this in their press release.
I sincerely hope it is just a labelling issue or small discrepancy. Just good to have an understanding of the broader trends.
I'm sure this will be dismissed as deramping..
I have to admit, after the shock result yesterday, I unfiltered Petch007. Petch's non-stop negative comments were becoming very annoying but I've realised the value in reading all perspectives. Not really sure how people can argue against the results of the study which Petch has cited:
"The delays caused by these CRLs could in some cases be substantial. The median delay was 13 months for Class 2 (generally major) resubmissions, though those delays could be as short as 3.5 months and as long as 26 months. Class 1 (generally less serious) resubmissions had a median time of 4.4 months (range = 1.5 to 9.1 months)."
The eternal optimists on here who are saying we are only a matter of days/weeks from approval (and were saying approval on 13th Feb was 99% guaranteed) - where are your studies to back this up? I am a LTH and I fully believe in the efficacy of Iclaprim and will be holding on until approval (and beyond) but I think we need to face the facts that we are probably talking about months, not weeks.
CRL*
Newbie question here: If the FDA only needs some additional data that Motif already has, would they not tentatively approve the NDA rather than sending a complete response letter? Is it possible that the deficiencies are more serious than the sketchy details which have so far been announced?
This board has stopped making sense! I have Petch filtered but people keep engaging with him, resulting in completely meaningless exchanges :p.
Roll on the PDUFA announcement.
This board has stopped making sense! I have Petch filtered but people keep engaging with him, resulting in completely meaningless exchanges :p.
Roll on the PDUFA announcement.
Hi hailo, I'm a long term holder here (mostly bought in at around 37p) and I've also read this or similar stats. If that is indeed the case, wouldn't approval already be priced in to some degree?
Yes, we're going to the moon.