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Another negative article published by Motley fool today. There seems to be a will to be some kind of organised downer on six on line....they talk about shares prime to be shorted and sometimes i have a passing thought that it's certain shsre media / tip sites behind the shorting....no way or evidence to prove it but certain company's get a relentless kicking by these sites at the same time. ..just a thought as I say but ....if even partly true...they often do a god job if it ..along with a few mates, helping along, doing there work ON the BBs...I'm probably wrong and not invested here although been watching for years.GL

Interesting imo
https://www.fiercebiotech.com/biotech/fda-delays-karyopharm-pdufa-to-review-extra-information

Jackdaw99. I hope your correct about FDA delaying process and kicking Motiv decision down the road due to FDA shutdown. If correct you would expect a significant rise in other company's, similar to Motif being treated in a similar fashion ...ther would be a spike in company's given delay info, waiting for approval...
...surely it would have been a more sensible response for Motif , it's sp, reputation and its investors to just announce that due to FDA situation then Motifs case will be delayed by six months.

They did give a reason , they want to investigate Motifs liver Data.....can't believe FDA would treat maybe a dozen other company's in a similar position ....just to avoid admitting a delay,which most people were half expecting anyway.

Motif have to tread carefully, they can't really comment on anything regarding what is required until they are formally informed themselves...anything new, even the slightest news, good or bad will be magnified, with a corresponding sp reaction..so I hope they keep quite until they can inform / update us with the facts. Now that twill be an interesting day here.

Thanks Waccy. A very guarded reply which is to be expected, I guess. Well done for trying. Vas

Yes I agree. If the problem is about data. .it's data that's been submitted and already appeared in post trial reports...starring us in the face maybe...
All we know its data regarding the liver.
Shame someone can't just lift all liver data from trial result data and to see where there could be a liver results issue....otherwise just wait to be told.

I cant understand why that 40 mg group only appears in that one paper....I can't find any evidence of a 40 mg group in any other literature - so there probably was never any 40 mg group and if so, the FDA wound be asking questions about it surely - especially when they were involved in the trials themselves.

We have been told that the company will need to raise funds sooner rather later......im wondering if the sp behaviour is part of that process.....most company's on AIM will dilute to raise funds ....maybe the price has been set...and the funding is being arranged orchestrated in readiness for the rns....if its a dilution then we all know it was going to be at a cheaper sp than it was a week a few weeks ago......so we may be close. just a thought.

Many thanks for posting your findings Tp23.

Have you read the discussion section in the article below. It may make more sense to you than me.
https://aac.asm.org/content/aac/early/2017/11/07/AAC.01184-17.full.pdf

Cheers Vas.

Thanks Tp23. I will read your post several tomes and try and follow the science.

Just my initial thoughts...But my original post that reviewed the data was written in a way that confirmed a 40mg dose was provided. Even though I could not find any evidence relating to it, in the results data..are you thinking that the 40 mg dose was included in trial but not included in the trial publication. Thanks again. Vas

Hi DrSandy,

While the rest of us lost souls are scratching our heads wondering what the FDA will come back with.....Your posts come over as if you have some idea what information the FDA may request. Can you share? You like to come over as if you know more than most. Prove it !

Apologies for my medical ignorance but if you look at the child Pugh chart. People identified in the A group have low, but worrying liver damage , B much more serious liver dammage with limited survival, and C worse time scales...

The 40 mg dose was provided to the B group ....you would think they would get the largest dose of antibiotic as their livers are unfortunately more damaged .......it does talk ( in my earlier link) about the two doses as if they were given but i can't find a reference to the 40 mg dose in the results......was everyone given same dose? Why even mention a 40 mg group. What about the unfortunate people on Child Pugh C group....they were not even considered? Are child Pugh C group patients presently treated by the Van.. ( our competitor, whatever it's called) , ..

I also. Not there were significant patients in trial who could not be followed up (in both groups) many identified as narcotic users etc..... I guess this happens on many trials ?

https://en.m.wikipedia.org/wiki/Child–Pugh_score

What's confusing me is this trial was at a fixed dose....but in one place it mentions referee was a 40 mg dose specifically for Child Pugh B patients? ...no treatment for CHild Pugh C patients....was there or was there not a 40 mg group...no mention anywhere else.

"Study Treatments

Iclaprim was administered at 80 mg (no hepatic impairment or Child-Pugh A) or 40 mg IV every 12 hours (Child-Pugh B). Child-Pugh C patients were excluded from this study. The fixed dose was chosen based on a pharmacokinetic and pharmacodynamic analysis of 470 plasma samples obtained from efficacy and safety evaluations in previous phase 3 clinical studies [12]. Vancomycin was administered at 15 mg/kg IV and adjusted according to a nomogram with dosing every 12 hours (creatinine clearance [CrCl] =50), every 24 hours (CrCl =35–49), every 48 hours (CrCl =25–34), or according to daily vancomycin trough levels (CrCl 1 mg/L. Both iclaprim and vancomycin were infused over 120 minutes in 500 mL normal saline. Normal saline placebo infusions were used to maintain the blind where vancomycin was dosed at an interval greater than every 12 hours."

https://academic.oup.com/cid/article/66/8/1222/4739347

Many thanks Tp.

Just listened to it again ...I heard it as. "there has been no demand at this stage for additional study's" and " we have to sit with the FDA to understand what is the path forward from here" ......not absolutely conclusive, to be honest.
Interesting they mentioned that ALL data sets for Assist 1 and 2 were used by FDA...not sure exactly what's contained in all sets but I'm assuming there are no skeletons. Thanks again.
We will really have to just wait for an update in a few weeks.

I can't remember if I read it myself or I read it on this BB? I would like to see it again. It's quite an important quote...from BODs if true.

Thanks IT
I thought I have seen it but now can't find it..ill have another look. Cheers.

This comment has been mentioned a fair bit here...was it from the conference call in February, or somewhere else. Does anyone have a link to it. Thanks in advance . vas

This paragraph below led me to Basilea....

"Iclaprim then passed through several hands before Motif Bio picked up the asset in 2015, following which it grossed £24.8 million (US$31.8 million) on the AIM in London and a further $25 million in placings on Nasdaq and AIM, as well as a $20 million debt facility. From the outset, Motif Bio maintained that iclaprim was partly a victim of circumstance.

Part of its pitch was that a policy of extreme caution had prevailed at the agency following the emergence of liver toxicity problems following its approval of Sanofi SA's Ketek (telithromycin). A slew of other antibiotics was caught up in the same atmosphere. Some, including Orbactiv (oritavancin; The Medicines Co.) and Vibativ (telavancin; Cumberland Pharmaceuticals, Inc.) made it through eventually. Others, including Restanza (cethromycin; developer Advanced Life Sciences Holdings Inc. ceased operations in 2011) and Zevtera/Mabelio (ceftobiprole; Basilea Pharmaceutica AG), which is currently marketed in multiple other territories, have yet to get past the FDA. (See BioWorld Today, Feb. 6, 2015.)

Right now, iclaprim belongs in that latter group.

http://www.bioworld.com/content/déjà-vu-all-over-again-motif-bio-hit-crl-iclaprim-nda-0

Basilea failed FDA in 2016 I think....liver toxicity issues ....they went on to sell in other territory ( not USA) ....but I notice are back with same drug....but funded by the federal government US!!

"Advanced the ceftobiprole phase 3 program to access the U.S. market
Basilea advanced its phase 3 program comprising two cross-supportive studies aiming to gain regulatory approval for ceftobiprole in the U.S. The U.S. market is an estimated 80% of the global market for branded hospital antibiotics based on value1and therefore it plays a critical role in Basilea's commercial strategy for ceftobiprole.

The first study, in acute bacterial skin and skin structure infections (ABSSSI), started in February 2018 and the second study, in Staphylococcus aureus bacteremia (SAB), was also recently initiated.2 The studies are conducted under Special Protocol Assessments (SPAs) agreed with the FDA.

The phase 3 program is funded in part (up to USD 118 million, which is approximately 70% of the total estimated program costs) with Federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201600002C. For the first half of 2018, Basilea recorded reimbursements for R&D expenses for this phase 3 program from BARDA in the amount of CHF 13.2 million."

https://www.globenewswire.com/news-release/2018/08/14/1551250/0/en/Basilea-reports-half-year-financial-results-reflecting-strong-in-market-product-sales-growth-in-addition-to-progress-and-expansion-of-the-R-D-pipeline.html

Ivy and All. I found this quite an amazing read..just the fact that they are thinking about investing this sort of money just stimulate future AB research to secure a safer future . Its a big document and interesting also...but pages 4-7 is well worth a read.

http://drive-ab.eu/wp-content/uploads/2018/01/CHHJ5467-Drive-AB-Main-Report-180319-WEB.pdf