The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
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Hey Ivey, I have valued all of your recent input; Question: Would the FDA have issued the CRL if the ONLY issue is indeed related to labeling? Since there was communication back-and-forth during the review process, wouldn't the FDA have told Motif during the review process they would approve the NDA, but with labeling / restrictions? Or is it a mandatory step in the process to issue the CRL and discuss labeling at subsequent meeting? Would the FDA have a subsequent meeting to give Motif the option of approval "now", with labeling, or would Motif prefer to do some kind of small study now, to address concerns, so that the approval could be given in the near-future w/o any labeling? thanks
Looking at nasdaq sp, not sure if much will happen until news.
Think we should start seeing over 10p from tomorrow and then a rise in the 20's following a positive RNS from Motif following Fridays meeting. Still got a long way before we can expect to see £1 plus. May not even be this year.
Scott. Look mate, I’m not looking for an argument but I never lied as you all it. Please read my post Sunday 16:27. You are quite blatantly twisting words to your own agenda which is unfair and not on. I suggest you look at your own posts before twisting others. Any and all can see my 16:27 post and it’s blatantly obvious I did not say what you are claiming
Scot. I’m not deramping as you call it, simply stating my belief based on facts such as the RNS and the webcast you pointed me too. If anything it is you that’s being rather “choicey” over some of the words in the webcast used for example. But that’s not a dig just saying, people in glass houses I stated both sides of the argument on the trials (see my post Sunday 16:27), so not sure if your point Are you not also guessing? I believe so. Not sure why you feel that way as if you read my posts it’s far from deramping, in fact the total opposite in most cases
It is a small sample, so I have gone over the last 2 years of approved drug applications and come up with the following graphs (I love data entry):
https://imgur.com/a/SkTFvzz
I couldn't get a list of CRLs by month because it seems the information is not available however that would provide a more complete picture:
https://www.fiercebiotech.com/biotech/fda-chief-gottlieb-backs-away-from-plan-to-publish-crls
exactly right spike.
Scot, ultimately we have to remember the CRL/FDA is a process. The meeting wasn’t particularly immediately, you need to look at the guidelines. Motif requested the meeting after the CRL was issued as standard practice. The FDA then have 30-45 days to meet....in fact it took from the issue of the CRL on the 14th Feb to the 3rd May (77 days) to meet...(less some time lag in requesting etc). Further data was indeed prepared from external third parties but it’s unusual to issue further data until the FDA Type A meeting, as that’s when you really find out why detail is needed. The CRL then Type A has little to do with the drug at times, it’s normally the process and right of the pharma to request the meeting which is normally granted unless the drug is a total flop I think your reading too much into things Scott.
Normal day in the US tomorrow, no public holiday so yes, Nasdaq trading as usual.
So I assume the Adr Nasdaq shares are trading tomorrow?
Scott, just listened at they said “the fda were willing to do the meeting”, so be mindful, not picking on words but it’s very different to FDA “requesting” the meeting” I can see FDA issues around toxicity and have a feeling that they will want a further trial, given some within revive 2 had Hep A also. Whilst circa 3% on numbers seems a small trial. That said review questions were addressed with use of outside experts, so they seem well prepared. Interesting to see after NDA review no questions in CRL re efficacy, but seems surrounding around elevated liver levels. I don’t believe the FDA will just “change their mind”, both politically and clinically after putting this in the CRL. Currently no demand for additional trials according to webcast however. My feeling is the FDA is using a lower level of acceptance than motif potentially, and that’s the stumbling block. 3X upper limit is the marker, but none of the results from Iclaprim exceeded that.....which begs an interesting question....why deny the approval? CRL says liver toxins yet it appears within the 3X guidance. Motif also looked at 5X, which was again within FDA guidance levels I do think it very odd that they would not go into any detail on the CRL contents however. Interesting times.
What was the outcome of the repayment of loan notes at $7mil due 18th May? I know they were looking at the raise option but wasn’t this for “working capital”?
wouldn't argue with that at all spike.its just a possibility.originally i would have given it no more that 1/10 as a reason but now i would give it 2 or perhaps 3 out of 10 but its all just speculation.good to know we will have some facts in the not too distant future.
Will do Scott, have you got link? Wasn’t a dig buddy I just haven’t seen other video as yet :) so I was only going on the detail in the RNS
Whist a theory let’s not get carried away, it could be as simple as that period less drugs where suitable. If you compare other parts of the year you’ll see similar patterns. I guess it simply depends on what drugs are sent to the FDA in any given period. One month you could get a load of rubbish next month could be all superb. Luck of the draw. However I do think it will get to market, it’s just a case of sooner or later, play with caution at this stage for me. Ps....not trying to put dampener on things lol ;) just a cautious guy ;) Enjoy the bank holiday all and let’s keep fingers crossed for the next month
interesting wackybaccy.i have not previously subscribed to the shutdown theory as it smacked to me of straw clutching.however the figures you have highlighted do seem to indicate that there may well be something in it.going to be an interesting few weeks now!
Scott, read the RNS of the 14th Feb “Bio plans to request a meeting with the FDA as soon as possible to discuss potential options to address the deficiencies.” The FDA didn’t request one, Bio did. The likelihood being the request after the CRL is a formality so I wouldn’t be reading anything into it. Given phase 3 trials, it would have been beat on impossible for a meeting to have been turned down so this was a simple and logical process procedure imo We thought 99% approved, then look what happened. In pharm nothing is 100%, even now, so my advise is never gamble more than you can afford to lose in pharm/bio plays However fingers crossed!
I'd been wondering for a while whether the FDA shut down affected approvals of new drugs and had been flummoxed for a while with my Google skills not finding anything. Well, today I found the relevant FDA page and some evidence to support the theory:
Go here and stick in February 2018 and compare against February 2019.
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process
We see the FDA approved twice as many new drugs in Feb 2018 than 2019 (16 vs 9). The government shutdown lasted for roughly all of January. Food for thought.
Bring back the real ScottPalmer250! Where are all your anti-ramping comments when we need them?
Someone has informed me that Virtu are in fact a Market maker rather than an institution but anyway indicative of anticipating higher volumes
https://www.virtu.com/
Thanks Ivy - they'll soon have as many as you, me, Sheltie and Ian B!!
(M)ay (T)he (F)ourth (B)e with us
Gla
About 400k shares as these are US ADRs