Rainbow Rare Earths Phalaborwa project shaping up to be one of the lowest cost producers globally. Watch the video here.
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The RNS would of been written before the meeting happened and sent out before 19:00 purely as confirmation. Do not read anything into the intent or hidden meaning of wording. It is confirming the meeting happened and wasnt postponed ect.
It all hinges on minutes or any form of leak from either MTFB or the FDA / family / friends, which although unlikely is a possibility.
Morning.
Correct Scooby-confirmation of the Meeting taking place is important as it means that the Meeting submission package was fully accepted as not requiring any modifications.
I know that is expected but don’t underestimate what is required in these submissions.
FYI this may help explain procedure and process of these meetings.
So is Tyoe A meeting following the CRL requested by MTFB
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM590547.pdf
Most interesting is the final paragraph relating to TYPE A meetings -
Before submitting a Type A request, requesters should contact the review division or office to discuss the appropriateness of the request.
Therefore if a request was not deemed appropriate a meeting would presumably not be agreed.
Also Section 11 or X1 covering FDA Minutes
Scooby
Think of it this way: would you say "I have been bitten by a dog" or "I of been bitten by a dog"?
Bring back the real ScottPalmer250! Where are all your anti-ramping comments when we need them?
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!
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
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.
So I assume the Adr Nasdaq shares are trading tomorrow?
Normal day in the US tomorrow, no public holiday so yes, Nasdaq trading as usual.
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.
exactly right spike.
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
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
Scott...will you please stop being an a r s e and picking selective parts from people’s posts to cause confrontation! As is say my post was clear, but you conveniently miss the part within that post that said.... “Currently no demand for additional trials according to webcast however” Or indeed the section.... “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” So please stop trying to make fellow posters looking idiots or you will now be reported and filtered. Do I need to continue? (And start quoting some of your blatant lies and twists..quote “Interesting that they were willing to do the meeting basically immediately on issuing the CRL”....mmmm now this tool 77 days)...or quote “Listen to the start of the webcast. It�s there crystal clear. They (the FDA) want a meeting”...again twisted when you listen to the actual webcast from the link YOU posted” Now let’s just leave it there shall we.
Scott for god sake man! No I did not Jesus, just bloody read my post of 16:27 Sunday, it’s really not rocket science unless you are inept at reading. Why you feel the need to argue and try and make people look fools is beyond me, it really is. You appear one of the worse for “half facts” and “twisted truths” to suit your agenda on here, so I suggest you pipe down a bit. You seem totally inept at reading someone’s post...my 16:27 post sums everything up so may I suggest you actually read before making stupid responses
And to answer your question Scott, my view has not changed since my said post. There maybe the need, there may not be the need. No one knows. As you do not know either, albeit you seem to think you do and appear to have had sight of the CRL and Type A meeting minutes already Another one for the filter list it appears