Rainbow Rare Earths Phalaborwa project shaping up to be one of the lowest cost producers globally. Watch the video here.
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do you know last year there was a bill before congress to import much cheaper drugs saving vast amounts but the bought and paid congress voted it down. seems astonishing but it happened.
i dont have a high opinion of anything american but I suppose the FDA are seriously intent on not looking stupid by approving what turns out to be dangerous. accordingly more likely to be suspicious of small unknown companies with no track record led by someone who does not impress.I hope nevertheless it gets approved and soon. who knows? like others I cannot make sense of much of this.
If true, I do find it remarkable that Lumsden has no shares; why on earth not ?
Dont worry WACCY -Ian B will be back soon. On wednesday he said he had NO DOUBT it would be approved. How can anyone be that sure? either a fool or a paid ramper.
completely agree jackdaw99.obviously the conspiracy theory is possible but i think its unlikely for the reasons you give.problems created by the shutdown are imo a little more likely but not particularly so.my guess(and thats all it can be at this point)is that the FDA have been doing the job they are in existence for i.e. safeguarding the interests of the american drug consumer and that they have some concerns about the liver tox data which is what we have been told.hopefully the concerns can be addressed without too much difficulty and we shall have a clearer idea about this in the next 3/4 weeks or so if not earlier.
Article from about one year ago about small companies and CRL's
https://www.evaluate.com/vantage/articles/data-insights/are-small-companies-carrying-complete-response-letter-can
I would never believe any conspiracy theory except when it come to money, drugs, oil and the US....then anything goes😁! Just ask yourself...most on here leading up to the 13th feb were 85-95% sure of approval. Why not 100%....every piece of the commentary released by the company indicated that it was very positive. I dont think its a case of the big boys buying mtfb.....for them and the fda, i think its more a case of they dont want a worldwide vanc monopoly risked and a cutting of the huge profits that come with it. Reference that bbc article....im always amazed that there are never any protests from the insurance companies..amazing! Play the game...some you win, some you lose i suppose.
Hmm angle brackets went bad. This is the FDA reply I got:
Please be advised that we are not aware of where you may find “the number of CRLs issued by month”. However, you may find “the number of CRLs issued by the year” in the following resources:
(lots of links, none very useful)
Glad someone looked at my charts, although sadly inconclusive (apart from it being a case that post-Christmas the number of approvals always drops a bit). I have been chatting to the FDA CDER SBIA department about getting a list of CRLs by month but all they said was:
<
And it is entirely up to the company that received a CRL whether to announce that they got one. Here is my post from last week for those that missed it:
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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
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j99, you hit the nail well and truly on the head.......(and we will probably never know ...)! Every observation is a speculative point of view, some more likely than others, but still imo speculative until FDA minutes issued. Even then the minutes may well obscure the reality, for example your post earlier
Can't agree with these conspiracy theories. A larger AB manufacturer trying to influence the FDA would be taking an enormous risk of anti-trust fines in the US, Europe, and rest of world. Just not worth it, even IF the integrity of the whole FDA mechanism could be compromised, which IMO is about as likely as those suggestions that NASA faked the moon landings. If another Co was afraid of the MTFB threat it would be much "cheaper", weighting costs with risks, to simply buy them, especially at these valuations. I can't see anyone refusing, say, 80 pence right now, and that still wouldn't be expensive for a major player. So no, for me the most likely scenario (and we will probably never know ...) is the administrators in the FDA finding every excuse to slow things down while their wages weren't being paid - we even have some circumstantial evidence for that (lovely charts BTW) posted on this board.
Sheltie, agree with that view. I posted on Monday, 'Conspiracy Theories" with a speculative suggestion that a US competitor could be influencing the progress, or not, of MTFB. Despite being based in the US, and with approval of Iclaprim will be focused on the US market, they won't have the political clout of major US players. Trump's economic isolationism policy will no doubt help.
Pure speculation on my part but until such time as we get clarity from the FDA minutes every observation/opinion is speculation.
https://www.bbc.co.uk/news/world-us-canada-48241663 Says it all really....money talks all over the world and especially in the us and with big drug companies. Will the applecart be upset...no, it will be managed through for the benefit of the big boys and if a few prisoners are taken on the way...too bad, we should not be gambling with the money they give us...hhh!
Cliffst85 - it’s a ‘political’ thing rather than ‘clinical’ I reckon. People with contrarian interests to those of MTFB lobbied very hard and won. Time will tell what damage a second refusal will now have caused (one refusal was previous to MTFB), but we will know for certain soon enough. Then it will be case of “end-ex” if the meeting did not yield a favourable outcome. .ATB
Well hanibal, IMO (inexperienced opinion...) I would say there *might* be less revenue if the warnings are strict*er* than vancomycin. Thing is, the prescribing doctors are going to always go for Iclaprim above Vancomycin for a given patient due to less risk of kidney damage, and better performance than Vancomycin (at least in the near term) due to reduced antibiotic resistance:
https://en.wikipedia.org/wiki/Vancomycin-resistant_Enterococcus
Hoping Ian.B will chip in as he seems more knowledgable than me on this.
(haven't listened to the podcast yet)
What do you guys think will happen, if they need to chance the label and have some restrictions on it? Posibility 3 from the analysts podcast??
I totaly agree with your point regards Vancomiycin in the latest podcast the analyst said that Iclaprim and Vanc showed up the same small percentage of patients who showed increased Enzymes in their livers in his opinion Iclaprim was no worse than Vancomiycin yet it didn't get approval one wonders- why?
Ian.B, potentially his arrogance (?) in assuming he would get approval may have carried across to the FDA bureaucrats in the meeting and put them off approval? I know that is unprofessional but stranger things have happened.
There is no doubt that he will have been much humbler at the recent CRL meeting.
All the facts on paper point to this drug being approved. On the off chance it doesn't get approved, I really really would want to know why it doesn't get approved when vancomycin has been. I think it will be a minor scandal if this does happen.
it's pretty lengthy as each therapy treatment has to be tailored for the individual patient but it is very effective and safe however this method of treatment isn't supported by the west as it's not as profitable and was invented in Georgia during the soviet era. However (having read the same article posted after me) it did treat the poor girl with Cystic Fibrosis who's body wasn't reacting to the antibiotics prescribed to her. So there is a need for a solution.....
Just a thought but what is the timescale with regards administering treatment to a specific patient suffering from a specific bacterial complaint, never mind maybe multiple bacterial issues? In many instances it is not the disease/clinical issue that kills but time taken to treat. Willing to be taken to task on this as not my area...
Good stuff for sure but very bacteria specific
Price has already been crushed
If we get bounces, im going to rip those pdfs apart, tables ,text and graphics :D.
If we get bounces, im going to rip those pdfs apart, ta :D.
Hemo, my understanding is it is FDA guidelines that the minutes must be published within 30 days. They could come sooner, 3 rd June is the deadline.
Cliff agree, i do recall his previous interview where he said it was almost certain to get approval and that the positive phase 3 results had taken out all the risk investing in motif.
No one expected the CRL and it was interviews like his that made us all believe approval was a formality. He is much more cautious this time around pointing out the risks and options to the FDA
We only have the phase 3 results to go on but they seem more than acceptable with all endpoints met and even in the area of liver tox that was cited as requiring more data they are comparable to the current standard drug used for ABSSI.
Gregreen
They always update or tweak every month or two so really just to.include lates but of news like FDA Meeting held.
It is more subtle changes I look for and more about emphasis.