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Yes, easy to knock and spread nonsense with these bios.

Angle are going for FDA De Novo classification for Parsortix. Submission for approval has slipped from around the end of June to the start of Q4, so slippage of about a quarter. The FDA have a review period of up to 150 days for De Novo applications so they are the timescales according to the Company and the FDA rather than posters on a bulletin board.

Regardless of SP action today, it's great that a small UK bio has managed to take a device through to a pivotal trial, that the trial has met all of its endpoints and shortly they'll be submitting an application for FDA approval for a completely new class of medical device. Good stuff.

Looking forward now to hearing more about the new ovarian cancer study.

Dibs,

ASCO is the annual meeting of American Society of Clinical Oncology - the biggest oncology scientific conference is the world. Around 40,000 attend each year and it's often used by pharma as a platform to present news and clinical results as it attracts maximum attention.

Angle will be there and I know for sure there are at least 2 or 3 (but probably more) abstracts being presented which feature Parsortix.

Excellent news. The study met its primary and secondary endpoints!

We can only guess as to what additional studies are required but the term 'remaining analytical study work' and the timescales and costs involved don't suggest anything major. In bio terms, a delay of just over a quarter is really very short.

I suspect the timing of today's announcement is no coincidence - the opening day of ASCO

I'm sure everyone here hopes that the FDA's decision allows MTFB to take Iclaprim to market without further trials and also that the forthcoming collaboration evaluating Iclaprim in cystic fibrosis lives up to the potential seen in the lab. If not, I hope you'll agree that the Cystic Fibrosis Trust would be an appropriate and worthy recipient for your donation.

Honestly, I hope everyone here will take the time to watch the video below right to the end and listen to Elle's Mother's comments. It's just a couple of minutes. I have also put a link to their JustGiving page - you would be able to make a donation using your lse name, thereby answering the Doc's point about proving you have donated.

https://www.youtube.com/watch?v=EFE1J2oeJ00

https://www.justgiving.com/cft

You are convinced that the FDA decision will be further trials are required (option 3) and promised to donate £1000 to charity if that wasn't the case. Do you have a charity in mind or are you open to suggestions?

Good grief - nobody has ever claimed that Iclaprim would become the gold standard treatment for all cases of absssi or that it would replace Vancomycin.

There are always posters who claim that one drug should capture the whole market. If they're positive about a stock they use this to validate (usually ridiculous) future valuations and if they're negative they use it to explain why the drug will fail. These posters are either genuine but naïve or being disingenuous. Whether it's an cancer drug or an antibiotic, the markets are vast - and bios don't have to better the SOC treatment for every patient.

As we saw on last week, it can take nerves of steel to hold bios and it's so easy to create panic.

https://www.youtube.com/watch?v=K-tgpLXsnf8

Below is link to a short synopsis from AN, recorded after his Proactive presentation last night. Clusters, clusters, clusters.

https://www.proactiveinvestors.co.uk/companies/stocktube/13484/angle-plc---proactive-one2one-investor-forum-may-2019-13484.html

Good interview - clear and concise.

Thanks very much for your comments and feedback.

Doc, lol - probably post of the day

Seriously folks, the idea that any one of us has the knowledge, experience, skill or information to second guess the outcome re. minutes from FDA is bonkers.

Ivy - thanks very much for taking the time and trouble to attend AGM and share feedback with this bb - appreciated

It doesn't work like that.

I'm not sure what the panic is here - there is nothing new whatsoever in the RNS in terms of the chances of, or requirements for FDA approval.

RNS Feb 2019 :-

'The CRL states that 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.'

RNS today:-

'Additional data likely will be required to address the Agency's concern about a risk of liver toxicity, the size and scope of which will determine the specific next steps'

What's the difference? It's just reconfirmation of what we've already been told.

InvestingWizard

Following receipt of the minutes from the FDA, the best case scenario would be an RNS confirming that Motif don't believe that any further clinical trials are required and that will be resubmitting the NDA, perhaps with fresh analysis of the existing data and maybe labelling adjustments. Worst case scenario is obvious!

Tilerman/InvestingWizard - agreed

Ivy - yes and thanks for link

Not sure whether it will help, but I'll try to explain my understanding of the situation re. the Arpida trials.

Firstly and probably most importantly, I believe the main issue wasn't that the Arpida trials showed liver toxicity from Iclaprim - it was that the data was insufficient to prove that it didn't and that there was a comfortable safety margin.

Generally, increases in ALT and AST levels were similar in both the Iclaprim and Linezolid arms of the trial and weren't considered to be of major clinical significance. Although overall levels were similar, increases for some Iclaprim patients occurred after they had completed treatment. There simply wasn't enough data to explain why this might be and I believe that was the concern when it came to liver toxicity.

At the time an independent hepatologist carried out a review of all available clinical data and his/her findings were that there had been no cases of liver failure, no evidence that any patients with pre-existing LFT abnormalities developed any liver impairment and that Iclaprim and Linezolid produced very similar frequencies of elevated liver enzymes. However, there was insufficient data to rule out a very narrow safety margin.

Must stress, this is purely my understanding based on my own research. Hope it helps.

All clinical and preclinical data for Iclaprim will be relevant and so of course the 2006 Arpida clinical trial results will be of interest to the FDA and I would expect that they'll have been looking just that little bit more closely at any issues arising out of those trials when evaluating REVIVE 1/2 data.

I expect that you're spot on regarding the reasons why the 2018 Form 20-F didn't go into the same level of detail as the 2019 Form, however the information was freely available on Motif's website via the AIM Admission document which contained a full discussion on hepatic effects shown in the 2006 Arpida trials.

Yes, that's my understanding too. I just wanted to make it crystal clear as anyone looking in who may not be over-familiar with the clinical history here may have thought the data came from REVIVE 1/2 Motif trials.

Some great posts from both yourself and PharmaGiles - thanks.

Think it's worthwhile clarifying that the 3 sentences in InvestingWizzard's 13.33 post refer to results from trials run by Arpida back in 2006, not Motif's trials.

The Aprida trials used a weight based dose and the comparator arm was treated with Linezolid. Motif's trials used a fixed dose and the comparator arm was on Vancomycin. I seem to remember that any patients with liver impairment were also given a reduced dose but would need to double check on that one.

You're right - will leave you to it.