Member Info for Ivyspivey

Nothing from Cayman Courts next week.

https://www.judicial.ky/wp-content/uploads/courts/grand-court/GrandCourtList21stOctober2019.pdf

http://www.ukrainianjournal.com/index.php?w=other_new&id=8713

For anyone interested I just looked on the website under Webcasts and Presentations to see if their had been any update from last one which was 14th June and this was the wording on there.

More information is coming soon

This is just in case anyone wants to monitor what may or may nit be happening

Morning and no one can predict outcome here but Featheryvest has 4 posts 1st one positive then sells and then goes very gloomy when the only thing that has changed is confirmation of what most of us already knew that an additional trial would be required.
It will not be the administrator etc that decides the outcome here in terms of finding a potential partner.It is a small field of potential participants.
The process of finding potential partners for HABP has been going in for years so the potential folk to approach will be well known to MTFB and advisors the only position that has been truly crystallised is the much weaker bargaining position of MTFB and the deal any potential partner will have to do.
I am not saying it will be easy to get a deal but it will not be any future administrator that decides that.

Pebsi you don’t need to understand how it works but yes it kills the bad bugs with less chance of developing resistance.
Any drug will have both beneficial and potentially harmful effects and it is a question of balance and risk benefit.
Obviously the FDA has a concern with Iclaprim re Drug Induced Liver Injury and has suggested a way forward but a costly one in time and money. It has not rejected the drug totally but as MTFB has no money without a partner it cannot progress the pathway on its own.
Whether a white knight comes to the rescue is the $64m question

Pebsi.To clarify this class of ABs(DHFRs)is not resistant to superbugs but has a few attributes urges which make it less likely to develop resistance.
1.Is novel and works within the cell rather than cell wall.
2.Is bactericidal rather than bacteriostatic.
3.Not structurally related to other ABs apart from Trimethoprim.
4.Not used in veterinary medicine.
5.Works at very low sub theraoeutuc levels.
ATB everyone and have a nice w/end

Evening.
We know this SP is at rock bottom levels and we know they need to find a partner to move this forward.
So what is in it for a potential partner?
Firstly they need to assess the likelihood of generating positive safety and efficacy data vs HABP and secondly they need to be confident of securing the necessary additional safety data to address the FDA concerns over DILI.
Anyone claiming they can predict with certainty the outcome here is purely guessing though we know they face an uphill struggle.
If a partner does sign up and we know it is a big IF then I will take that as a big sign of confidence as they will do a lot of DD in making any decision.
However if they do sign up and they believe they can turn this around then they could get a great deal.MTFB are desperate and by conducting one phase 3 trial that is most likely to get them Approval for both HABP and ABSSSI and yes it will cost in money and time but will be much cheaper than starting phase 3 from scratch.

Is this new or not.Anyone?

https://youcontrol.com.ua/en/catalog/company_details/40060180/

Imo any new NDA would be submitted for both HABP/VABP and ABSSSI as long as the new data proved satisfactory to alleviate the current FDA concern in DILI.
It is clear that at the preliminary meeting back in April 2015 that they would accept one HAVP and one ABSSSI trial to get Approval for both so certain in my mind that they would accept 2 ABSSSI and one HABP especially taking into account 21st Century Cures Act.
The pathway offered via HABP is to attract a potential partner who could gain in both HABP and ABSSSI markets however I am not underestimating the challenge of securing such an agreement.
If a deal is done then this is is a great risk/ reward but we need to wait for news.

Bailed in Time.
I see you were using the QTc point as proving the need for a comparator which I fully agree with and is consistent with what has been said by MTFB in recent months and as I have said I think the HABP is purely the way forward to attract a partner and at same time provide additional safety data to address FDA concerns.
My reference to QTC was purely one of saying the ABSSSI trials seemed to satisfy the FDA re Iclaprim safety but obviously issue of DILI remains.
Sorry if I misunderstood your point re QTc but think we are agreed that any further phase 3 trial will need a comparator and I do suggest it will be based on Inspire protocol as why reinvent the wheel.

https://s1.q4cdn.com/460208960/files/pictures/2018/06192018_MTFB_1.png

See page 4 of attached Zacks report

https://scr.zacks.com/News/Press-Releases/Press-Release-Details/2018/MTFB-Completes-Submission-of-NDA-for-Iclaprim-article/default.aspx

The Inspire protocol is the HABP phase 3 trial planned for some time by MTFB but nit proceeded with.
It has an agreed comparator and primary and secondary endpoints and a CRO had been chosen.

Bailed in Time
Whilst I do agree with some of your sentiments and there will be a comparator as I say with the Inspire protocol which I am sure they will use it is Linezolid.
However a couple of your points are baseless.
The FDA did not raise any cardio or QTc issues with fixed dose Iclaprim i/v and HABP is not a completely new indication in that the FDA were happy to accept 2 ABSSSI or 1ABSSSI and 1 HABP to get Approval in the preliminary Meeting.

Evening.Have not posted much lately and won’t talk about about the future prospects here but couple of comments.
Whatever the requirements of the FDA re another trial the reason imo why they are suggesting a HABP/VABP is its appeal to a potential partner.Absolutely no point in repeating an ABSSSI trial.
A single trial with a comparator likely Linezolid as this is already agreed with Inspire protocol so they would need to prove efficacy in HABP and of course the additional safety data could pave way for a new NDA seeking both ABSSSI and HABP Approval.

Coggy what about when in Spandau you can wear Ballet tights and sing Vienna rather than Berlin.
Or have a big Brockwurst sticking out of your Werner Scnitzl

The future for the vast bulk of these type of treatments and therefore the trial process moving forward is in Combo with CIs rather than as montherapys however outstanding due largely to small cohort sizes and lack of interest in financing these type of programmes by bigger pharma players.
Moving forward the cost of the CI will already likely to included by the payer but the cost of the additional drug will need to be provided by the smaller player but there is the possibility of getting these costs paid for by the relevant health authority if the Company can reach a relevant agreement.
Due to the wish to keep the costs of these trials as low as possible and the general lack of financial resources most of these AIM bios have then this can compromise the speed in recruiting trial patients and opening if a big number of trial centres

Coggy trying not to make Woolies the window to watch.

https://www.youtube.com/watch?v=8SeETmUOBTs

Of course the other interesting thing is the GM to be held.Where and when and likely held after the minutes have been received.
An opportunity to question the BOD or simply vent as there are a few things I am deeply disappointed with in terms of their conduct over recent months

PR
Yes we have both lost here and of course there are lessons to be learned including being too confident but I repeat no one predicted the CRL with accuracy including these far more expert and informed than likes of me.
Fairly simple equation for me.If they get a partner then huge upside if no partner comes in then it is bust.
If you are buying in at current levels you may worry about day to day movements but for LTH like myself who have just written this off at much higher average I will just wait.
If it goes bust from these levels no matter but if a partner comes on board then I will buy a lot more and don’t have to worry as much about the scramble to get in as if I was out completely