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Chill smalltrader, it’s a discussion board, I’m dimply thinking out loud, sharing my thoughts and throwing ideas out for discussion, I thoughts it’s what these boards are about. Doesn’t mean I’m right! Jam tomorrow, thanks for sharing now I understand a little more about the process
Spike, you started off this thread saying MTFB is keeping quiet since May 3rd as they knew it is not going to be approved and that you are going to be out of MTFB tomorrow morning and when Scott countered you then you started adding IMO to your posts! I know it is a pressure situation but don't start posting like SP250!
The FDA meeting is like an interview for a job. You may think you have done well or not done well but you willnot know the result until you hear it from the company/FDA!
GL is not a cowboy ceo and all the news we got since CRL indicates it is all positive but again you will not know the end result until you hear from horse's mouth! IMHO
Jam absolutely right imo and yes you won’t get answers but to me clues are better than nothing.
This was posted by Jimmybob on May 3rd
I have been in these meetings you are asked questions and give answers but you don’t get an approval or not or more data answer, everyone is poker faced any decision is provided after the meeting. JB
Seems to support the idea that Bod will not know for definite until minutes are produced. I've always understood minutes to be a recording of what happened in the meeting; but it SEEMS that any decision will be an addendum?
This would explain a very tight ship news wise, when I predicted otherwise.
Maybe not answers at AGM, but possibly clues?
surely the minutes to which a link has been posted are minutes for the meeting held at the end of the initial application process at which of course a decision would be reached.they are not minutes from a post CRL meeting .we are in different territory now.imo
If my mind serves me correct the information was also issued prior to the type A meeting (wasn’t this mentioned in the conference call?) so a review process would have potentially already been taken by the fda prior to the meeting, which would tie in with the format in my link.
Spike I don’t think that type of Meeting which seems much more like a mini Ad Comm where members of a Committee vote is like the one MTFB have attended.
I don’t think it is a FDA Committee that will make a decision at the Meeting by voting but will consider how MTFB have presented and answered the query’s and respond accordingly
Scot, no I haven’t. Please read my posts I’ve in fact been saying the very opposite However I did find what looks like an example set of minutes from 2008 and a previous drug, which shows voting for approval/or not within the meeting. I’m not saying that’s is what happens here, and it is 11 years old, but it simply makes you think and would explain the reluctance to comment Simply sharing research, no more no less. Doesn’t mean I’m correct of course
You've been saying that the FDA have given MTFB their decision, which I think is highly unlikely, particularly if MTFB have given them additional information. This isn't a regular company or parish meeting, where simple decisions are made off the cuff. I think the FDA are in total control and just take in information, which needs to be properly processed within the 30days.
If the format is the same with the voting, it would certainly explain the radio silence, as the outcome of the vote would need to be in black and white before declared to the market Unless I’ve got this wrong, it makes this stock very interesting indeed
We simply don’t know and as I said this will affect outcome.
I am sure MTFB will have a good idea of path forward and will have been working on options to cover different scenarios.This does not mean they expect bad news it is simply good contingency planning and one of main criticisms mine included was lack of this planning in view of the CRL.
The AGM is just an opportunity to get a better feel for how they see things rather than simply guessing.
We know they will release any news in an RNS rather than at a meeting but any insight imo is better than nine and we know in the valley if the blind the one eyed man is king lol
So if the format is the same, they may well vote within the meeting for approval or not!
I think it’s also not helped by the words “minutes” which eludes to conformation of spoken word. Rather dated but I’ve found the link below which seems to give meeting minutes, albeit from 2008 so format may have changed but maybe gives us little insight https://wayback.archive-it.org/7993/20170404043729/https://www.fda.gov/ohrms/dockets/ac/08/minutes/2008-4371m1-final.pdf
Scot, that’s not what I’ve said buddy. That’s why I have been saying there would have been a series of actions from the meeting, which motif will have to work on. Then the post type A meeting can be requested if so needed. It won’t be an approval there and then your right, simply a discussion on next steps to “get it approved”, which the bod will of course know. Minutes will simply be the record imo Key is how long and complicated these actions are, and we know aim is fickle and lacks patience in an already tricky market
If MTFB gave them information in the meeting, the FDA are not likely to respond in the meeting, 'oh, that's alright then, it's approved!' They know they have 30 days to respond so they'll use it. IMHO! :-)
Imo nothing will be added. You can’t have minutes on record then add things to them after the meeting, this goes against “minutes” I would imagine there would have been an action plan and a list of actions, with a further review. I believe there is a three month post Type A meeting that’s normally held (but I’m sure others will correct me). This meeting I believe is where any actions coming from the initial meeting are reviewed (ie the extra detail etc required) It’s likely the Type A was a discussion on the CRL followed by a list of actions that motif will take away and work on. The timeframe for these actions will be key to investors as it maybe a quick fix it may take a number of months. We simply don’t know
IMHO, there will be minutes in the strict sense of the word, but then a whole lot more added, including their decision on the way forward.
I think it's inconceivable that MTFB know the exact outcome and haven't acted on it in some way, in which case it would have leaked.
Scot seems it was pointless going to the meeting then ;-) unless they sat in silence ;-) Imo the options would have been discussed and a forward plan (action plan) agreed. What that is we do not know, and I may be wrong of course, but some form of “next steps” would have been agreed imo All guesswork at this stage big fingers crossed it all works out for us all
Unless you are experienced in these type of meetings it is hard to precisely to know whether the official minutes are simply a confirmation of what as said/agreed or more likely imo a reflection and confirmation by the FDA of their response to MTFB position.
So yes the BOD will have a good idea of how the meeting went but depending on “ how predictable” these minutes will read is crucial.
That is the type of question along with others I want to ask at AGM and gauge response. Normally I would just e mail GL for clarification but they are very tight lipped so will simply wait for AGM.
ATB
OK, they may have an idea of the outcome in general terms, but they won't have been told it will be approved or require particular labeling or further trials. There is guidance on the nature of the meeting and what to expect from the minutes and they can definitely add information, advice or anything they like, it's their procedure, so they set the rules.
It's not like a regular company meeting, where you would be rightly annoyed if the minutes didn't reflect exactly what was said and agreed.
Below you will find a portion of the strategy discussion included in MTFB's Form 20-F filed with the US Securities and Exchange Commission (SEC) on April 15 2019. You can think of Form 20-F as a type of annual report that a specific group of foreign issuers have to file with the SEC.
Based upon the statements in between asterisks, MTFB has a good understanding of what it would take to allay the concerns of the FDA. It even sounds like MTFB and FDA had have ongoing exchanges from the time of CRL issuance through Type A meeting date. According to MTFB: ***At this meeting, we intend to discuss the existing data contained in the NDA submission and supplemental data analyses that have been provided to the FDA, anticipating that this may be sufficient information for regulatory approval in the United States***.
I don't recall that MTFB ever disclosed elsewhere that they provided supplemental data analyses to the FDA. The time required to prepare the supplemental data analyses may explain the delay in holding the Type A Meeting. Under normal conditions, the Type A meeting would have occurred no later than late March 2019.
I am fairly confident the publication of the outcome of of the Type A meeting will have a positive effect on the share price. The referenced disclosure was all I needed to buy as many shares as I could afford. As of today's trading session, I am done buying MTFB shares. I am ready to hear the FDA's verdict and hopefully celebrate a multiple fold increase of the share price.
========================================================================================
Our Strategy
Our goal is to help physicians to treat hospitalized patients with serious and life-threatening infections by developing novel antibiotics, designed to be effective against multi-drug resistant bacteria. We are pursuing the following strategies:
· Rapidly address, to the satisfaction of FDA, the issues raised in the CRL for Iclaprim. We have submitted a “meeting package” in response to the Complete Response Letter received from FDA and previously announced on February 14, 2019. FDA has confirmed receipt of the meeting package and has confirmed the date for a Type A meeting on May 3, 2019. ***At this meeting, we intend to discuss the existing data contained in the NDA submission and supplemental data analyses that have been provided to the FDA, anticipating that this may be sufficient information for regulatory approval in the United States***.
· Commercialize Iclaprim in the United States If Approved . We intend to commercialize iclaprim in the United States for ABSSSI either by building sales, marketing and market access teams ourselves, partnering with a contract selling organization or identifying a strategic partner with commercialization capabilities. We are seeking proven commercialization partners in other key global markets.
Scott. I disagree, I don’t think you would go to a type A meeting and not come out with any idea of the outcome. Isn’t that the whole idea of the meeting? I would also not be impressed if things were added to minutes post meeting. If they need more trails, details etc this would have come out in the meeting as the next steps (ie the outcome of the meeting). But, as ivy said, we are all second guessing based on our own gut reactions and feelings. We should find out within next two weeks either way
They know what was said in the meeting, but they don't know the outcome. The minutes aren't a straightforward record of what was said, the FDA can add to what was said and that presumably includes any judgment, assessment or further advice. If they're presented with information, it's highly unlikely they would give an off -the-cuff assessment and detailed way forward in the meeting. They would just gather any additional information they need to make their further judgment.
Agreed, Ivyspivey
Ivy, well put. I guess all we can do is go with gut instinct based upon our own experiences. That said, and as I’ve alluded to, I’m “umming and arhing” about my holding, the downside (relative to where we sit now), vs upside potential is tempting, but, at the end of the day it’s a pharmaceutical play AGM will certainly be interesting. May look to attend work commitments pending
Evening,
It is really very simple.
They won’t say anything until official minutes are released even though they will have a fair idea of how the Meeting went and likely outcome.
Anyone who is pretending they know the outcome of the Meeting is imo flying a kite.Like the PDUFA decision there will be no leaks and folk can only guess.
In any vacuum people get consumed with rumours and counter claims and make decisions based on little genuine info.
Really suggest people wait for news.
As for me yes I will go to AGM and form an opinion based on what is said and conversations and interaction with folk I have known a very long time. Not 100% as nothing is but a bit more useful than not going and simply trying to interpret folks thoughts whom I have never met and often with an unknown agenda.
Simple choices