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If elements of trial were to be altered, then one vital input is response from CRO. I think they are vital for cost and time implications and another necessary cause of delay.
From FDA guidance on type C meetings:
The official, finalized minutes will be issued to all FDA attendees (with copies to appropriate files) and to the sponsor or applicant within 30 days of the meeting.
So 30 days from when? I believe meeting was held several weeks ago and yesterday's rns was a contingency statement prior to AGM in lieu of the awaited FDA response. So response not September but mid July IMHO
Oh leas. I remember your insightful posts but failed to notice your concerns. Consequently I have been invested through the Great Fall. Perhaps better luck this time.
Lamebro222. I was going to filter you but your posts are kind of humorous so carry on making me laugh
From rns 7th February. Study on track to deliver results around the end Q1 2022
Not late by my interpretation.
Nolupus. Thanks for the post. Can't say i understood it all but the concepts were mind blowing. And Eureka are active in the field. Think where we can take this given cash from lupuzor!
Hi Ivy. Good to hear from you especially since you always provide such balanced comment. I'm still in. Having lost a pension on this seemed sensible to trust in miracles to bail us out. May just happen! Iclaprim flew through Its ABSSI phase 3. Its safer than vancomycin and is effective against antibiotic resistant bacteria. The preclinical tests in hospital acquired bacterial pneumonia were astounding compared to the approved AB's. The FDA wanted motif to continue and gather more data to address the possible and low level liver toxicity. If i was in hospital I'd rather be given Iclaprim than vancomycin with a 15% chance of acute kidney injury. Its a great drug and perhaps its found its time in this unfortunate pandemic. Hope you're keeping well Ivy.
Ivy, this and your earlier post are excellent. Thanks. I must take issue with your slap in face analogy though. As our LTH colleagues in another place will testify this has caused real pain if not long term physical damage. A slap is embarrassing. This was more like a kick in the balls from an old friend. Oh well. Like you I believe from the slim evidence it will be sorted and quickly. My bigger fear is the cash Raise.
Ian, so sorry to hear of the panic regarding your wife's health. And on top of our joint panics over the CRL. Fortunately your wife now sounds comfortable. I think we will eventually be OK too but as you said, puts these things in true perspective.
Fritz, my sentiments exactly. Nice to read it although just reinforces my bias. Expensive bias since I didn't top slice before results. Significant loss but convinced we'll be back to £1 plus by next year.
Rebarm. Good summary. FDA want/need this drug but are caught between wanting to approve and exercising due diligence because of inadequate resourcing. The 50% funding increase is unbelievable and warranted solely on the lives that can be saved.
In trying to thaw household temperature I discover my wife has been avidly reading this board. Her good question is why none of us potential warren buffets understood this increasing use of CRL over the last few years. I have no answer. Why didn't the M&G advisers also etc. etc.......
Although speculation is pointless until FDA meeting, I am finding it therapeutic to constructive reasonable narratives around what has happened. Thanks Tobias for suggesting a vital part.
- FDA want/need this drug (MOA, long term resistance, not least reducing deaths and injury in its initial target of ABSSSI)
- FDA are under-resourced and situation compounded by shutdown
- They did not have time to fully approve the perhaps wider labelling that MTFB required
- This was reason for delay in submission to get the (alleged) 3 top liver scientist opinions to accompany the trial liver data
- so issue a CRL not to delay but to enable approval without a black box; this is what all parties want.
Unfortunately this still doesn't clarify why discussions in the last 6 months didn't resolve and we ended where we did, so back to the drawing board perhaps.
Agree renroc. You provide a sad perspective on what is real.
IMM failed its Phase 3 and did not proceed at that time to an NDA because FDA would abviously not have approved it. So FDA did not fail IMM. IMM failed the trial it set itself. And importantly this has not proven that the drug failed. It has subsequently been shown to work extremely well in a cohort of the triallists with the required level of statistical significance albeit in too small a number to convince regulators. Yet.
Company has $12m cash but has $15m loan. So not short of cash.
M&G held over 10%
Have reread RNS many times. Here's another theory. Company over-reached itself on the labeling it asked for. Considering some high profile approvals where liver toxicity was later recognised, FDA are being squeaky clean in approving the labeling requested. So there are options some of which are quick. Ever the optimist but here's the relevant bit from RNS: the FDA cannot approve the NDA in its present form and indicates that additional data are needed to further evaluate the risk for liver toxicity before the NDA may be approved.
you need a good ABSSSI AB then. Oh, you're dead. Forget it.
Current SP way overdone. This is a drug that showed non-inferiority to Vancomycin in 2 Ph3 trials and superiority in a large subset of renally impaired patients. It is the first new class of drug to approach approval in many years and because of mode of action, very significantly less prone to resistance from superbugs which it is also extremely effective against. The FDA want to approve new antibiotics. The company were punctilious in following FDA guidelines. No liver toxicity was ever raised as an issue so I see this as a request to prove non-toxicity as a result of several prior high profile failures. Hopefully we have the data. I can see further tests costing time, money and dilution but the eventual gains to patients and shareholders are still here. The company needs to communicate more fully and we need the FDA meeting asap