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From memory I read somewhere that in 2015 ish ....icraplem had already around £300 million invested in its development....Since then ?

It does beg the important question.... if the FDA deal had gone through as expected in Feb., followed by an inevitable fund raise...where would the sp be now? At 6p today.....that seems a decent risk / reward ....so long as you are sensible.....that's why I was trying to find some comparisons on AIM ..similar size company's that had reached the
FDA holy grail and continued trading independently!

I also have no idea...so best forget about it....there's enough mystery here already.

https://www.ftse.com/products/indices/RussiaIOB

Thanks ivy.
I stumbled over this RNS yesterday. It's probably nothing but what suprised me was its referring to a Motif rns 27th Feb 19...one that did not appear on lse....so where did it appear?

https://www.proactiveinvestors.co.uk/LON:MTFB/Motif-Bio-Plc/rns/LSE20190227173104_13984250

Morning ALL

Yes. A phase IV, study does sound a reasonable solution ....if there is a need to capture more information.

I'm not entirely sure how this would be viewed by the market....as company remain on FDA watch, with chance of being taken off shelf in future, nor regarding any predictors.

Phase IV studies consist of post-marketing studies to delineate additional information, including the treatment's risks, benefits, and optimal use. Phase III studies allow ‘only’ thousands of patients to be monitored compared to a phase IV study where the entire population of patients exposed to the specific drug are monitored. Occasionally products are withdrawn or use thereof restricted when phase IV studies for example indicate long term adverse effects or adverse effects for specific high-risk groups (Johnson-Pratt 2010).

Many Thanks Tp23. I'll have a read later. Thanks.

From what I understand Iclaprim was a fixed dosage at 80mg ....and thats how it has always been promoted....the fda were involved in advising motif before and during the trial ( a posative, you would hope) ) and would have known it was a fixed dose...so imo it's unlikely they want data regarding a 40mg cohort at this stage, surely....unless something seriously went wrong with the communication.

I don't know what data was captured in phase 1& 2 ..was 40 mg used in the earlier trials?

Ive also struggled to find company's on AIM with low market cap that have been successfully awarded by FDA. There are many examples of large market cap company's getting success but useless in comparison. Even if the small caps were bought out after success there would be evidence of payments made, and how much above sp. I did come across a couple of small caps bought out ..can't rember their names and one in particular share holders got a 80% increase on current sp.....v.god but not amazing. There are so many variables.

I don't know if I'm alone on this ...but I thought Iclaprem had big advantage on competition on liver results I.e Iclaprem recovered from toxic shock.., where competition did not.....but it's looking like, unless someone can challenge on this...that both drugs in trials had similar liver recovery.....I thought that the liver recovery was one of Iclaprems Unique qualities ..following results .....but the way it's worded seems they were similar.

I looked at the trial data that Ivy kindly supplied and could not find a 40 dose only mention of a 80 dose....if part of trial it would be there.......thanks Vas

Hi the Italian.

This looks like the link. I'll read it later. Thank You.

https://lib.ugent.be/fulltxt/RUG01/002/062/116/RUG01-002062116_2013_0001_AC.pdf

Your more than Welcome Ivy. Thank you for your support on this board.

Ivy. I think you would have seen this before but maybe good for people like myself. I've had quick glance and will read later.
https://www.fda.gov/downloads/guidances/UCM174090.pdf

Sorry Should have read

really appreciate the time you spend answering these questions ...but it's not so clear in the text that return to baseline only applies to Iclaprim.

Many thanks Ivy.
The line where the increases resolved to Baseline values upon discontinuation of the drugs in ALL patients" . Is this ALL patients treated by both drugs or just Iclaprim....as not very clear to a non science person as myself.

Do you read this as Iclaprim liver safe and vancomycin significantly less liver safe....not clear to me.
I really appreciate the time you spend answering these questions ...but it's not so clear in the text that return to baseline only applies to
Begs further question about why liver safety advantage of Iclaprim was not mentioned in the recent presentation after FDA response......

"Fifteen (5.5%) patients in the iclaprim group and 10 (3.8%) patients in the vancomycin group had increases in alanine aminotransferase or aspartate aminotransferase values to >3 times upper limit of normal (ULN) during treatment.These increases resolved to baseline values upon discontinuation of the drugs in all patients. No patient had bilirubin increases >2 times ULN. No patients met Hy’s law criteria in this study."

Many thanks in advance Ivy. Vas.

Can anyone confirm that in the Iclaprim Revive 1&2 results that liver toxicity returned to normal shortly after treatment? It interesting that there was no mention of this liver recovery in the recent conference call.....if you look at the results below from conference call between vancomycin and Iclaprim ......it is in The "Revive pooled" data results both drugs look v similar but in the individual Revive 1 and 2 results vancomycin looks marginally better.....if liver recovery is true, with Iclapram then you would expect that fact to be in the data as it beats competition hands down....but there is no mention of Iclaprim's liver recovery potential, anywhere. I can only think either a) the liver recovery story is just not true ....Or if someone can confirm the liver recovery in trials was demonstrated Then maybe the liver recovery data was not mentioned in conference call as it is that data the FDA want to investigate further.

"On the conference call, questions were asked regarding iclaprim liver toxicity trials, specifically if the levels of liver toxicity were “physiologically meaningful”. Motif Bio highlighted the data from its clinical REVIVE trials which compared liver toxicity to Vancomycin. Vancomycin is an FDA approved drug, which also treats serious skin infections from bacteria that is unresponsive to other antibiotics.

In REVIVE-1 trials, 5.5% of patients in the iclaprim group, and 3.8% of patients in the vancomycin group, had elevated levels of aminotransferase (AST). AST and ALT are biomarker tests for measures of liver toxicity. REVIVE-2 trials revealed that 3.7% of patients in iclaprim, and 3% of patients in vancomycin, had elevated levels of AST.

A pooled analysis of both REVIVE-1 and REVIVE-2 looked at combined terms for AST and ALT. It was found that 2% of patients using iclaprim, and 2% of patients using vancomycin had elevated levels of AST. Interestingly, only 1.9% of patients in the iclaprim group and 2% of patients in the vancomycin group had elevated levels of ALT.

Good Morning The Italian. Thanks for responding to my post.
I'm looking for a comparison as close as comparison as possible over past decade....can't find any that ten based on FDA approval....but from what I've read and I am just a lay investor. ....I've come to the conclusion IF / when motif get the FDA approval and if it's market is so atractive then it provably won't exist a few months later. ..swallowed hole.
At this price i could imagine a ten bagger from here....as doesn't look ridiculously optimistic. ..especially after the 80% punishing fall last month...so I'm in.

I just find it strange with all the hype of ten bagger in biotech company's that we can't find onew. .over this past decade....the press are full of it every year....1 in ten successful. ...where's the one in ten that shows a ten fold increase in sp....and I don't mean over a ten year period ....as often the drugs patents expired by then or soon after....sorry for typos on mobile.

Stedon.

That's one of the best quotes ever and one of my favourites. It's so true, it applies to all areas of our lives. It should be on the National Curriculum. A great motivational quote there Stedon. Not sure what it's doing on this board....

That's true. But we would expect a FDA a approval to trump a share consolidation. Remember we are only looking at the period between the date a company actually submit their application along with their data and the date they succeeds their FDA application. It's what happens the days, months after the successfully FDA application that matters ( I'm guessing but I'm sure many a share dilution takes place) .

All we want is 2 or 3 examples of a small bio on AIM preferably that gets a thumbs up from the FDA for their new drug....looking for at least a few big multibagers realistically....if there are non...then why?

Peeps on BB talk about 10 baggers in pharm stocks as if they are relatively common.....well let's have a few examples.

Birdseye. It looks according to the ten year chart that the sp collapsed in 2017 after initial FDA rejection and since then has only doubled it's SP? Not the sort of result you would expect considering FDA aproval came in October 18.

There's some very knowledgable posters here...it's the weekend ..lets hope they find the time to post up a few fantastic examples. I hope so. More examples the better imo.

It would be interesting to find more examples. ..I know each company is so diffetent in so many ways but observing what happens to others once FDA is approved could be enlightening.

Just put in specific search words in quotes..like AIM, FDA etc sky rocket ha ha

https://www.darkdaily.com/customized-cancer-vaccines-based-on-individual-patients-dna-could-soon-be-a-reality-might-require-diagnostic-support-from-anatomic-pathology-labs/