Member Info for Ivyspivey

Important bit from article

Based on the current understanding of iclaprim's PK/PD profile, the FDA recommended that a fixed dose of iclaprim be used in the ongoing iclaprim phase 3 clinical program, since previous PK studies demonstrated no relationship between weight and clearance (C

Hi Vascular,
Would be interested if you can find the link to the article.Excluding certain groups like very obese folk if they are representing if this patient population would be picked up by FDA like it was in original Arpida trials.
The Revive ones did not have such restrictions.The creatinine one is a funny one as that is relevant to kidneys only and that is strength of Iclaprim

Hi TP
Normal length of tretmentis 10 days but big improvement is moving to fixed dose 80mg I/v do not weight related issues.
Many patients in this group are overweight and any weight based regime increases scattered issues if both liver and heart as you are giving much more of drug

TP23
They also had issues with efficacy re comparator Linezolid,some of trial sites and also Cardiac safety as well as liver toxicity issues.The issue of Ketek loomed large at the time so the6bhave improved the safety and efficacy issues dramatically as well as passed CMC issues.
Can normally get an Approval with a black box liver warning if necessary but thinknMTFB want a clean label.
That position can change depending in specific FDA concerns

Vascular
Very poor journalism imo.
Why would you suggest selling something that he thinks is worthless.
Always plenty of Jeremiah’s who appear after the event.I can’t think of any commentator that did not expect Approval.
My main gripe remains the apparent lack of any contingency plan by the BOD in the event of a CRL.
The January comment re FDA if true is interesting as this insinuates it is a labeling issue and maybe there is something in the US shutdown not allowing the FDA enough time to fully review the MTFB response in time for PDUFA but we can only speculate at this juncture.
Anyway little matter of Man U vs Liverpool to prepare for so won’t comment unti later and maybe not at all depending on my mood lol

NAP
The value is all in the Approval decision.
ATM I would say if they sold it in a fire sale they could get $100m assuming the FDA issues are not “ insurmountable” which I am sure they are not as you would get a full rejection.If there was more than one bidder this could easily rise.
If they get Approval this is easily worth $1bn plus.
I would be interested to know can we confirm the FDA asked “ liver toxicity” questions in January.
MTFB gas been in lockdown since Xmas and seems quite late in day for FDA to ask questions.
If they did ask this late I am heartened as only label discussions this late in process which are more minor in nature.
All will be known soon .The clues will be how much easy is it to raise money and if course the FDA meeting.
Still think the BOD are confident about Approval but we all are in a bit if the dark until we know more

Life’s a game
The whole environment has changed due to no new ABs and the Ketek debacle.
They increased p3 trial numbers/changed the comparator/ changed the NI margin/ went to fixed dose 80mg and used the best CRO ie Covance hence passed both p3 trials

Andy Smith.Hardly an independent commentator when he writes notes for Destiny Pharma

Destiny Pharma (DEST)
INVESTMENT SUMMARY
Destiny Pharma is a virtual UK antimicrobial discovery company in Phase II clinical studies in the US. Destiny’s XF series of antimicrobial agents are novel, rapidly bactericidal and not associated with bacterial resistance, which typically limits the use of other antimicrobial agents. This makes Destiny’s lead product, XF-73, ideal for the prevention of post-operative infections, an indication in which no other drugs have been approved. We forecast Destiny’s cash reach to at least 2020, with Phase IIb results for XF-73 available at the end of 2019.
INDUSTRY OUTLOOK
While there are valid commercial criticisms of antibiotic development, the growing problem of antimicrobial resistance is making non-dilutive and alternative funding methods available to make antimicrobial drug development easier on companies. In addition, resistance has not been observed against Destiny's agents and their new preventative indications make antibiotic stewardship less of an issue.

Cheers Shafqut- link provided.Also a special appeal court sitting Monday but not FRR

https://www.judicial.ky/wp-content/uploads/courts/grand-court/GrandCourtList25thFebruary2019.pdf

http://cbw.ge/economy/natia-turnava-georgia-supports-development-of-south-gas-corridor/

Calamari
The cost will be in range if $3k-4K for a ten day treatment.
It has a specific economic model which it has had for 3 years

From 2 years ago

Thanks FM.Did not realise I had copied the last from bit from the twitter photo

Sorry can’t copy ot

DO2nY4HWAAMEHb0.jpg

DO2nY4HWAAMEHb0.jpgFrom

https://pbs.twimg.com/media/DO2nY4HWAAMEHb0.jpgFrom 24/8/17Please let me know if you think this is normal trading

Hemo,
What you have to remember is that the 3 of us are all heavily exposed here so is totally different buying more when you have a small holding as opposed to already hsving a big holding.
I will not buy any more at these levels unless it is for a trade but if I only had a small holiding uescI would be buying more.
Again like Shektie would probably wait until news on FDA meeting bad funding before making a big move but would exiect a slight rise precnews

Got it from one of early MTFB presentations.
Iclaprim is bacterio cidal( means kills the bacteria) quickly with a fairly low dose rate .
Most other ABs are bacterio static( means stops development of bacteria rather than kill).
Important difference in helping prevent AMR(Antimicrobial Resistance) but there are several other reasons why Iclaprim has a low propensity to resistance including not being used in animals,being novel so a DHFR so structurally unrelated to other ABs,kills within cell etc

CFP
The table is 3 years old and they highlighted main hazard of Linezolid as affecting diabetics