Member Info for Ivyspivey

https://www.motifbio.com/iclaprim/#opportunity

Not a chance
As Ian B says on Approval all the broker targets will be raised as the risk factor will be discounted considerably as the final regulatory hurdle to launch us overcome
Also expect a big amount if MTFB communication and surevthey have been working hard these last few months without us having any news

PR
You mention the term binary play which technically you are right in sense it will be a yes or a No to Approval but I always like to assign a COS to any binary event so it is not seen a a 50/50 and then makes it more a priority to de risk.
I assign a COS here ranging between 90/10 or 95/5 in favour of Approval but that is only my opinion and each and all should make their own judgement.
What I would say if you did want to Derisk then as long as you did it before PDUFA date then you should be fine.
I just can’t see them deciding before 13th Feb and you have another month for this to rise in anticipation so I would not be in a hurry.
However all depends on size of holding/ average buying price/ attitude to risk etc.
Another very strong sign is the big players seem to be buying rather than selling and they have very big holdings at high averages.
Just so good to see this having such a good week and as Sheltie says those of us who have been here from the start have endured both good and bad times well this week is certainly one of the better tines

And a Tiddly Ted Poe

And a Tiddly Ted Poe

Hi PR
Yes zi know the FDA can change a PDUFA date just don’t think likely in this case.
Iclaprim is under priority review so if they brought it forward it would create a precedent so why would they do it.
Huge difference between setting a PDUFA date fir 9 months after acceptance of NDA submission and bringing it forward to 8 months than bringing it forward by 2 weeks fir Iclaprim as it means less than 6 months and 6 months is timeline set in Fast track kegislation
This is not an emergency medicine
Also it is a priority review with no Ad Comm as far as we can see.That t is a big positive in terms of how co operative MTFB and FDA have been and also in the chance of a successful approval but we just have over a month to wait fir FDA decision

Hi Kenco,
Agree mate wider market is much better but still very hopeful this will come good.
I am lucky in that any potential loss here was wiped out in 1 day of rises of one of the stocks on your list.
Just so many good folk here who deserve every success

No one can be sure but I am pretty sure the PDUFA date of 13th Feb will be decision day.
1. Under Fastrack it is 6 months from acceptance of submission of NDA.Tgey will not want to create a precedent.
2. We know under US shutdown FDA has resource issues.
3.All triggers re patent countdown and other stuff re other indications like HABP start from PDUFA date and organisations like MTFB plan accordingly.That us why they have a specific date.
If it came earlier or later these plans could go awry.
Thus imo it will not come earlier

MTFB =+10%
MTFBW=+32%

Yes very familiar and that feeling when you have a big chunk and you get the big rise.That is worth all the down days.
Really think that will happen here.
When the SP falls so low you naturally question why even if you are confident in the fundamentals and if you are 10s of 1000s down you should always question your investment.
However if you believe like I do here then it can turn so quickly like with Angle and elsewhere with one mega RNS

Currently MTFB +10% and interestingly MTFBW +18% and at these prices the warrants come into play lol

Yes we all owe a lot to Mr Mole for his informative posts and wish him well in facing whatever issues he us currently dealing with.

At how DNL responded today
Predictive text

Calisto look st hiwcDNL tespobdedvtiday with extended patent news lol

FYI here us a recording if thecAugust Ad Comm to discuss Omadacycline

https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/Anti-InfectiveDrugsAdvisoryCommittee/UCM616433.pdf

Hi MTP
The Scientific Advisory Committees(Add Comms do not cover every drug NDA submission.The anti infectives one which covers ABs last met in August and don’t know about live streaming but you do get a full transcript of what was said by both parties.
It appears that Iclaprim has not had to have to have an Add Comm( if it had to MTFB would have been ready) but it will have saved them a lot of money and time in not having to prepare for that eventuality.You should not underestimate how much effort would be required to prepare for this ( would have cost MTFB in order of £1m).

I checked the FDA list this morning and. Nothing is scheduled so looks like the decision will be announced on 13th Feb without any Ad Comm meeting

Who would sell 53 shares at 32.35 when they could have bit more unless of course they wanted to try and stop the rise

Chris are
Can’t see it being earlier as 6 months under Fastrack from acceptance of submission date.
They like to stick to PDUFA dates and changing them is unlikely imo as sets a precedent.
Different for emergency type submissions like Zia or Ebola treatments

Don’t disagree with your assessment of he man in charge
I understand the FDA shutdown is only affecting later NDA submissions so PDUFA date of 13th Feb should not be affected.
Unless the situation worsens but so far so good

Hi Genghis,
Pretty confident that cash balance is still pretty high as they have not spent much since end of June.
NDA submission fee was waived.
Not started HABP
Not finalised EMA submission
No evidence of recruitment of US Commercial Arm
They have very low cash burn( when outside of trial expenses) as they are such a small team
No AdComm so saves a lot of time and money?

They also have the remaining $5m from Hercules facility so think they will have plenty of cash.
The real question to me is how are they going to spend it