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Here's one example I just found, ...Antares Pharma listed on Nasdaq. The FDA turned their drug called Xyosted back in a complete response letter last October ( imagine that was October 17- and then a year later FDA approved October 18 ),

If you read this .....
https://www.fiercepharma.com/pharma/aiming-for-abbvie-s-androgel-antares-scores-fda-nod-for-testosterone-drug-xyosted

Then look at the SP performance graph......
https://www.nasdaq.com/symbol/atrs/stock-chart

Anyone have any better examples of FDA approved drug company's that spike on approval?

Thanks Jam.
Ill have a look at that one. I am interested in exactly what happened the following months after FDA approval - as that's all that's matters really......the response from each company's share price will be different according to the market opportunity suddenly available to each.

I have read some peeps only invest in company's awaiting stage 3 approval ...which sounds sensible to me....even better odds if you can / only get in on the day approval is announced.

Anyone got any more....

I have asked this question before and did not get a response so I thought as its quite here, and maybe for several weeks - I thought I would post it again. Its not a de ramp , in fact I am invested here but would like to see an example of what is hoped for here, having happened previously on an AIM stock ( regardless of Nasq listing)..

Can anyone give me the name /s of other pharam stocks, listed on AIM during the past decade or so that was successful ( as we hope Motif will eventually be).

A company that was once a penny stock like Motif, which won FDA approval for their new drug which transformed the company's share price to a ten plus bagger / £1 stock .

Can anyone think of examples of what we hope will happen here - having happened previously.

https://www.investmentweek.co.uk/investment-week/news/3071817/bosses-of-struggling-city-financial-borrowed-gbp4m-from-business-reports

Thanks DR. Any guess if all goes well in future at what Motif share price would AMP even begin to contemplate selling what looks like a lot of shares?

It's a strange feeling I get here as on paper it looks like Motif have passed the FDA exam with extremely good results - possibly best in class...only to have been suspended due to lack of working out notes ......the tease is that they got the correct result....so in theory.....they have passed....just hope their is nothing in the missing in their " working out" notes that's negative / or misleading.

Can someone please put me straight on what debts MTFB are now carrying.. Hercules was recently partially paid down as recently announced but isn't there a considerable amount due to be paid to AMPiON in September 19. Can some one please confirm what the total debts owed are, and the timeline for repayments....Many thanks Vas

I agree that the drop was heavily influenced by two IIs selling millions of shares on the opening bell....but If the sp drop was only due to this factor alone ....then why hasn't the market bought back these ridiculously discounted shares and caused a sp recovery......I think everyone is waiting for a clarification....the clarification news will probably be the most important RNS the company will ever have to put out, and if it's positive news ...the BODs better make sure the information contained in RNS is clearly positive, concise and not ambigious .

The last thing we need on clarification day will be everyone scratching their heads with uncertainty ...asking if the news is actually good or bad .....I believe peeps And IIs will invest in motif again regardless of whether the clarification we recieve is good or not so good news...as long as it's honest, with a believable timeline and a confident BODs who can demonstrate that they can arrange the funding that will drag this company over the FDA finishing line.

Everywhere I read and from what is known the drug has Been successfully proven in trials, and is safe! It's also a new type of antibiotic resistant to MRSA etc which in itself makes it unique at this time...I'm hopefull this car crash / oppurtunity is not at all related to the performance of the drug, whicj looks highly successfull but more of a administrative negotiation about the labelling and how it will be catagorised along side the very tired looking competition....saying that I find it hard to understand how the FDA could allow this drama in sp to happen to such a small, and seemingly successfull company ....the reasons given ( as we were informed) regarding more data needed. ..could have taken many a company down.....it was a rather heavy handed way to path the way to a further discussion between the FDA and Motif.....either the FDA are careless or maybe more to the line " more data neded"....I can't believe a further statistical graph added to the existing data sheets will make this all OK.

On identifying patients who would best respond to IMN

https://www.genengnews.com/news/cancer-immunotherapy-bite-method-may-identify-patients-who-will-benefit-most/

The
Labelling issue is as good a guess as can be made at this point but there is no evidence to confirm this....so it is possible that the FDA are wanting something more...

Can't help thinking this little drama is just to get the sp up to cover a placing...or something along these lines. .

Thanks Juniperst. What you have posted sound very sensible and plausible imo

Surely the FDA who had a hand in advising Motif for their trials - Could have mentioned this earlier!

Lets hope, if this is the actual hold up, Motif are allowed to capture any further data .....after the drug is licensed by FDA .

My understanding is that the label issue is very important as it will dictate the size of the market they can sell into.....so I would love this to be around the labelling .....but how can issues around labelling be linked to what the FDA want to see...namely more data around liver toxicity ......the only connection I can think of is whether the FDA need to decide whether to allow the drug to be sold to everyone regardless of liver condition or limit sales to those with healthy livers.....maybe the FDA need further data on liver responses so to make this decision....but I am under the impression ( rightly or wrongly) that the guys in charge at MTFB are as in the dark as we are at this moment ...until the FDA Give further info........surely , if the BODs know more it would need to be disclosed via a RNs !

We have no more evidence of it being a label issue as we do with whether it will be contained using a cork or a screw top lol

Another article ..similar outlook to the Sunday Times....but gives a few examples of company's that managed to navigate the FDA to success .and a few that did not.
http://www.bioworld.com/content/déjà-vu-all-over-again-motif-bio-hit-crl-iclaprim-nda-0

Sorry Here's the link to my previous quote.
https://aac.asm.org/content/62/2/e01184-17

Morning Ivy. Thanks for your comments.

I found this article...and I will cut and paste a section that shows some concern around similar issues around weight etc in patient populations ...what I dnot know is how old this summary is and of course it nay no longer be relevent.

"Several things should be noted in interpreting these findings. Similar to most phase 3 trials involving patients with skin and soft tissue infections, the ASSIST-1 and ASSIST-2 study populations may not be reflective of the broad range of patients who have ABSSSI in clinical practice. Most notably, patients with a body mass index of >40 and patients with estimated creatinine clearance of <30 ml/min were excluded from the ASSIST studies. Given that these patient populations were not reflected in the simulations used to determine the fixed dosing scheme for the ongoing phase 3 ABSSSI trials (REVIVE-1 and -2 trials) and the planned HABP and VABP trial (INSPIRE trial) (1, 2), it will be important to assess the viability of the selected regimen as data become available. Finally, the PK/PD drivers for iclaprim are based on in vivo animal infection model studies and will need to be revisited once human exposure-response data are available."

I still can't imagine how Motif, could have managed to screw this up! the results look so good.

Yes. A very negative write up. I would expect such a write up as the story as we know it, is not great at the moment but I would also expect a mention of the window of opportunity that exists where Motif and the FDA go through the specific data in question, and the opportunity of turning this around into a FDA approval ......isn't that why the FDA wish to discuss further.....otherwise what's the point of dragging this on further....there must be a chance that this can be resolved either shortly or with later with further supporting data ...but not a mention of this.
I think the bit about a reversal of a private company into Motif was not about saving Motif, In fact Motifs business would fold ..but for a new company (not necessarily in pharma ) to get hold of the tax credits owed to the Motif the company.....and get a listing on AIM in Motifs place.
If the BOD throw the towel in, what is their to sell.....a failed FDA drug.

Has a feature about Motif.

https://www.thetimes.co.uk/edition/business/motif-bio-a-suitable-case-for-treatment-tbtrp693x