Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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Is it conceivable that the FDA issued a CRL to force MTFB to do Phase IV trials, which they wouldn't have done with a straight approval?
They're playing this out for the institutions not PI's. Making the long term proposition look good and enabling them to get in cheap on any cash raise. They could've kept completely stum, let fomo kick in before the minutes and raise at a higher price. Not very appealing to the bigger boys
Yeah, it's unfortunate people are missing the bigger picture. The drug will not be outright rejected from what is implied by the BOD. Therefore, what is left is a marketable product following a potentially small scale trial or a marketed product with a simultaneous small scale trial. Yes, it may result in a small raise but look at the ridiculously low market cap for the company. It's entirely possible they could obtain funds without having to raise. Furthermore, even if further small scale trials were required prior to marketing, this could be conducted alongside the HABP studies. So in real terms it isn't increasing the cost.
Phase 4 trials
Phase 4 is sometimes written as phase IV. These trials are done after a drug has been shown to work and has been licenced.
Phase 4 trials aim to find out:
more about the side effects and safety of the drug
what the long term risks and benefits are
how well the drug works when it’s used more widely
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/phases-of-clinical-trials#phase4
A phase 4 only takes place after a drug is licensed for sales.
Ill take a phase 4.
It's also entirely possible that if the licence was granted that the potential phase 4 studies could be funded by a partner. Worst case scenario, they will need to raise funds- how much we need to wait on minutes.
"the size and scope of which will determine the specific next steps"
If the co was cashed up, all would be calmer. But its not - and any raise will reflect the remaining risk discount.
That is why many will stay on the sidelines for the time being imo.merely trading on sentiment aka yesterday
People are coming to their senses hence the uptrend this morning
There is no reason, as of yet, to believe any trial needs to be conducted, as discussed yesterday. And even if trials are carried out they would be for a small subset and could entirely be carried out by way of phase 4 studies once the product has been marketed and commercialised.
the HABP trials may cost up to 40mln over 3 years
Which trials are these then?.......i must of missed a rns.
Think you/ll find a labelling issue will cost a lot less
Opioids are clinically beneficial for the use in which they were licenced. That is all the FDA will be licensing for. If the meds are being misprescribed it really does fall on the medics prescribing.
Sorry, but I have to disagree. The system is entirely logical. The phases include an increasing number participants and serve different purposes. Testing in a larger number of participants is the only way to determine with a level of statistical certainty that we know the full spectrum of outcomes associated with the drugs so we can assess the risks against the benefits. The study methodology will be fundamental in determining the use, so although your analogy would seem sensible it isn't entirely reflective. For example, if a teacher was examining you on engineering you can't expect to be qualified as a medic. The content of the examination will determine the output.
exactly! the HABP trials may cost up to 40mln over 3 years. Hercules still gets 6.5mln and at current levels Motif is only able to get 10mln GBP via placement? AND we dont get any return/sales income over the next 3 years. Thats why they urgently need Invescos support! Otherwise -game over.
......or the FDA or the Sackler family's fault!
Everyone seems to have it in for opioids. They are BRILLIANT. You will definitely be wanting some if you’ve acute pain. If people abuse them for pleasure then that’s not the opioids fault. When used as intended that are very effective.
The problem with investing in biotechs is that we are using logic to apply a set of probable outcomes but we are dealing with an often illogical entity in the FDA. It's like a student that passes all five tests in a class (for mtfb this is phase I, II, 2 phase III trials, and the submission of the NDA). The teacher gives the student passing grades on all five tests leading the student logically to believe that they will pass the class. When the time comes, the teacher fails the student telling them they didnt like an answer on the third test and to go back and retake it. The student is dumbfounded about why the teacher didnt fail the student the first time around. That's where we are with mtfb and the fda. It's hard to see the fda as capable given all the data and successful trials we have had. Now it's possible we will have to go back and do a 3rd phase III trial which, could spell the end for the company, or not of course. We'll know soon but I am now of the belief that after holding for 2.5 years, the company could very well be at its end if another trial is required. Hard to see the fda as highly competent at their jobs given how they approved all these toxic opioids destroying lives yet they might destroy a greatly needed drug. At some point you have to accept that the fda is an illogical entity and can deny approval for a drug based on a concern that we look at as entirely acceptable. The fda is sure doing their part in exacerbating the antibiotic crisis. Sorry for the rant but it's either this or fall into a bottle.