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AGM SEC Filing with resolution
https://www.streetinsider.com/SEC+Filings/Form+6-K+Motif+Bio+plc+For%3A+Apr+26/15411689.html
I am not sure sitting on the meeting minutes for 5-10 days would be considered illegal so long as nobody uses the information for their own gain. Ideally, MTFB would have already had in place contingency agreements with placement backers and potential commercial partners.
They have to take advantage of the potential multiple fold increase in the share price to minimize the number of shares they have to sell. Also, have an RNS on commercial partnership would certainly amplify the value of the share as well. This is all speculation obviously. What I am fairly certain of however is that the meeting minutes are already in the hands of the management team.
@DrMaccers: You are correct. I meant June 5th.
Did a search on Google looking to identify companies that both disclosed the date the type A meeting was held and the day the meeting minutes were received from the fda. One average the wait time was 21-23 days. Most companies prefer not disclose both pieces of information. If this estimate holds true, meeting minutes should already be in the hands of MTFB.
If MTFB does not issue an RNS on meeting minutes come May 5th, we can attribute it to any or combination of the following:
- MTFB is still clarifying with the FDA various aspects of the minutes
- MTFB would like to line up funding for cash raise to occur while share price is at +3 month high (this is provided that the outcomes of the Type A meeting are favorable to MTFB)
- MTFB is still finalizing the details of a commercial partnership in the US and would like to release news about the deal concurrently with outcome of type A meeting (this is provided that the outcomes of the Type A meeting are favorable to MTFB).
The count down is coming close to expiring... Fasten your seat belts ... We may be due for a fun or nightmarish roller coaster ride!!!!
GLTAH
The market is just digesting the interview the CEO did with Proactive Investors. GL indicated that there were 3 approval pathways still available to Iclaprim as opposed to just the worst one as the poorly written AGM testament may have erroneously conveyed. So now, the share price will settle AT A MINIMUM at the same level it was prior to the infamous AGM statement.
Based on all the research I have done including reading up on how other companies have resolved FDA concerns related to non-lethal / non-debilitating liver toxicity caused by an investigational drug, there are only two approval pathways left on the table : option#1 and option#2 as enumerated by GL in the interview. In my mind, GL included option#3 to show deference/respect to the FDA.
RNS on outcome of type A meeting will be published at some point between now and June 7. MTFB may need to use extra few days to arrange placement, finalize collaboration contract etc... I have seen companies release outcome of meeting with FDA up to 10 days after their due date. So do not be surprised if we experience a bit of a delay.
GLTAH!
Based on all the research I have done and the news developments from this week, we should look forward to some exciting NR to be issued by MTFB within the next 5-10 business days. Having said that, the FDA is unpredictable.
Wishing all of you a great extended weekend!
Let's not conflate cost of developing a drug with valuing a company. Pharma company are valued based on the revenue potential of approved/unapproved drugs. According to Zack's Research, Iclaprim (if approved) can achieved peak annual sales of $500Million in the USA alone. Keep in mind that this is a conservative estimate as it only accounts for US sales and Iclaprim being prescribed to patients with renal issues. So if we apply an ultra conservative price to sales multiple of 5, then MTFB may attain a market valuation of $2.5 Billion within 2-3 years of starting sales of Iclaprim. I looked up other pharma companies with one/two products in their portfolios and they have price to sales ratios ranging from 10 to 30.
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The company clearly realized that the AGM statement was poorly written hence why GL went on TV to provide additional clarifications. The additional context GL provided on the following statement was welcome news to me:
"Additional data likely will be required to address the Agency’s concern about a risk of liver toxicity, the size and scope of which will determine the specific next steps."
GL said the statement did not result from any recent developments in MTFB's interactions with the FDA. GL said the statement is simply a reiteration of the FDA's feedback as outlined in the CRL. So to me, we are back to where we were prior to the AGM statement as far as the approval of Iclaprim will not require major additional funding.
The fact that he spelled out the three most likely outcomes of the the type A meeting was welcome news as well. This is consistent with some of the accounts several board members gave about how the AGM unfolded. I have always maintained that a combination of Options 1&2 was the worst outcome we could expect. Option 3 remains a distant possibility because the FDA has a mind of its own.
All in all good interview! Looking forward to reading the RNS detailing the outcomes of the type a meeting.
@ScottPalmer250 - You must be a really lonely person. You spend quite a bit of time monologuing.
@Jimmybob - You did an outstanding job reading between the lines of the email from IR. Sadly, the FDA can come up with all sorts of excuses. They can move the goal post without fear of reprisal. This is because most if not all conversations between pharma companies and the FDA are kept under wrap. The point is, pharma companies hardly ever publicly challenge FDA's decisions. As we are learning through MTFB's dealings with the FDA:
-Full details of CRL not made public
-No specific commentary on the discussions that occurred between MTFB and FDA post issuance of CRL
-Full details of meeting minutes will not be released
-etc
MY QUESTIONS (5/22/19):
Hello - I will appreciate it if you can answer the following questions:
In today's AGM Statement, the company indicated that it is "Sufficiently funded to reach a decision point regarding Iclaprim based on the outcome of interactions with the FDA". What is the actual meaning of "decision point" within the preceding statement? Should that be construed as the receipt of the meeting minutes? Or as the PDUFA date that will be provided by the FDA upon re-submission of the NDA to resolve the deficiencies outlined in the CRL?
During the Revive I and II trials, did MTFB conduct liver function tests at each of the following checkpoints: A) at the end of treatment (EOT) visit, B) at the test of cure (TOC) visit (7 to 14 days after the EOT), and C) at the late follow-up visit (LFU)?
If yes, how did the results compare to the Assist I and II trials? In particular, did the AST/ALT levels of a set number of trial subjects continue to increase between end of treatment (EOT) visit and late follow-up (LFU) visit?
If not, why were those liver toxicity studies not included in the protocols of the Revive I and II trials since the results of the Assist I and II trials failed to provide valid explanations as to why certain trial subjects experienced continued increases in ALT values after stopping Iclaprim?
Thank you in advance for your answers.
=======================================================================================
EMAIL REPLY from MTFB IR (5/23/19)
Thank you for your email.
In regards to your first question, the ‘decision point’ can be taken as the receipt of the official meeting minutes as you mentioned below.
With regards to your second question, the Revive trials were conducted to be consistent with the protocol agreed with the FDA. Results on the liver function tests have been presented at scientific conferences and published in peer review journals.
OFFICIAL
XI. MEETING MINUTES
560
561 Because the FDA’s minutes are the official records of meetings, the FDA’s documentation of
562 meeting outcomes, agreements, disagreements, and action items is critical to ensuring that this
563 information is preserved for meeting attendees and future reference. The FDA will issue the
564 official, finalized minutes to the requester within 30 calendar days after the meeting.
The following are general considerations regarding meeting minutes:
567
568 ? FDA minutes will outline the important agreements, disagreements, issues for further
569 discussion, and action items from the meeting in bulleted format. This information does
570 not need to be in great detail. The minutes are not intended to represent a transcript of
571 the meeting.
572
573 - FDA project managers will use established templates to ensure that all important meeting
574 information is captured.
575
576 - The FDA may communicate additional information in the final minutes that was not
577 explicitly communicated during the meeting (e.g., pediatric requirements, data standards,
578 abuse liability potential) or that provides further explanation of discussion topics. The
579 FDA’s final minutes will distinguish this additional information from the discussion that
580 occurred during the meeting.
581
582 The following steps should be taken when there is a difference of understanding regarding the
583 minutes:
584
585 - Requesters should contact the FDA project manager if there is a significant difference in
586 their and the FDA’s understanding of the content of the final meeting minutes issued to
587 the requesters
588
589 - If after contacting the FDA project manager there are still significant differences in the
590 understanding of the content, the requester should submit a description of the specific
591 disagreements either:
592
593 ? To the application; or
594
595 ? If there is no application, in a letter to the division director, with a copy to the FDA
596 project manager
597
598 - The review division and the office director, if the office director was present at the
599 meeting, will take the concerns under consideration
600
601 ? If the minutes are deemed to accurately and sufficiently reflect the meeting
602 discussion, the FDA project manager will convey this decision to the requester and
603 the minutes will stand as the official documentation of the meeting.
604
605 ? If the FDA deems it necessary, changes will be documented in an addendum to the
606 official minutes. The addendum will also document any remaining requester
607 objections, if any.
608
609 For input on additional issues that were not addressed at the meeting, the requester should submit
610 a new meeting request, a WRO request, or a submission containing specific questions for FDA
611 feedback.
https://www.fda.gov/media/109951/download
X. MEETING CONDUCT
531
532 Meetings will be chaired by an FDA staff member and begin with introductions and an overview
533 of the agenda. FDA policy prohibits audio or visual recording of discussions at meetings.
534
535 Presentations by requesters generally are not needed because the information necessary for
536 review and discussion should be part of the meeting package. If a requester plans to make a
537 presentation, the presentation should be discussed ahead of time with the FDA project manager
538 to determine if a presentation is warranted and to ensure that the FDA has the presentation
539 materials ahead of the meeting, if possible. All presentations should be kept brief to maximize
540 the time available for discussion. The length of the meeting will not be increased to
541 accommodate a presentation. If a presentation contains more than a small amount of content
542 distinct from clarifications or explanations of previous data and that were not included in the
543 original meeting package submitted for review, FDA staff may not be able to provide
544 commentary.
545
546 Either a representative of the FDA or the requester should summarize the important discussion
547 points, agreements, clarifications, and action items. Summation can be done at the end of the
548 meeting or after the discussion of each question. Generally, the requester will be asked to
549 present the summary to ensure that there is mutual understanding of meeting outcomes and
550 action items. FDA staff can add or further clarify any important points not covered in the
551 summary and these items can be added to the meeting minutes. At pre-NDA and pre-BLA
552 meetings for applications reviewed under the PDUFA Program for Enhanced Review
553 Transparency and Communication for NME NDAs and Original BLAs (also known as the
554 Program),11 the requester and the FDA should also summarize agreements regarding the content
555 of a complete application and any agreements reached on delayed submission of certain minor
556 application components.
https://www.fda.gov/media/109951/download
Jimzi - Good thought! I quote you below:
****So logically, how do they know they require any more info.****
Seems the meeting must be very one way as the FDA boys won't say anything - ****it seems incredulous - you have a meeting but don't say what you want but put it in minutes that aren't minutes.****
Ivyspivey
Trust me, there won't be any new materials/discussion points in the minutes that were not discussed during the Type A meeting. I was able to review The Meeting Minutes of a Type A meeting unrelated to MTFB. It like the minutes of a city council's meeting. It included a listing of all the people that were present along with narrative of the discussions that goes like this:
-GL of MTFB gave a presentation about ABCD. He highlighted etc
-John Doe of FDA pointed to slide 5 of presentation and wanted to know why such and such...
-Jane Doe of FDA asked GL to elaborate on such and such statistical analysis.
Respectfully disagree. BOD already knows what the FDA wants. Minutes are just a summary of what discussed and any agreement that may have been reached. The documents is called "Minutes" for a reason. Pharma companies like to wait for the minutes before discussing required post CRL because they are the official records of what was discussed during the type A meeting.
It looks like whatever supplemental data they brought to the type A meeting was not enough to alley the liver toxicity concerns of the FDA. The meeting minutes are just a formality. BOD knows what the FDA would like to see. They probably are still negotiating with the FDA on size and scope of clinical/non-clinical activities or even post market approval surveillance etc...
They have yet to publish any extensive liver toxicity data from the Revive trials that can be compared to the liver toxicity data from the Assist trials. This is an area of concern to me. They either have the data and it does not compare favorably to the Assist trials or they omitted to conduct the same liver function tests during the Revive trials. Whatever the issue, the optics reflect poorly on Management.
MTFB needs to hire a good PR Firm. The cadence and content of their RNS come across as erratic and poorly thought out. Why comment on what the FDA will require to resolve the CRL when you have not put out an RNS discussing the minutes of the type A meeting? Why split the AGM in two separate sessions that are a week apart???
The only portions of the AGM statement that sounded upbeat to me are:
- Sufficiently funded to reach a decision point regarding Iclaprim ****based on the outcome of interactions with the FDA***** ( By Decision Point??? Are they talking about FDA's decision upon re-submission of NDA? It sounds like whatever the FDA is asking for will not require an amount of funding in excess of the not so impressive cash position of the company.
-***Continue to be approached and presented with opportunities***** based on Motif Bio's demonstrated ability to execute successful late-stage clinical studies (Companies/Universities are initiating partnerships/collaboration discussions)
-Currently evaluating a number of licensing and partnering opportunities
-Look forward to discussing additional pipeline developments at the appropriate time