The latest Investing Matters Podcast episode featuring financial educator and author Jared Dillian has been released. Listen here.
The share price was savagely and unfairly decimated when news of the CRL came out. The share price has barely recovered from it lowest lows. Market assigning a market cap of 30M to MTFB is utterly disrespectful and laughable if you ask me. However, that's the reason why MTFB represents such a compelling investment opportunity. My humble expectation is the market cap will gradually increase to a value of 200M to 250M after both content of meeting minutes are publicized and US and possibly Europe commercial partners are announced.
Technically speaking, the meeting minutes have been in management's hands for a few days (my humble theory). Effective tomorrow, we will be beyond the 30 calendar days wait time associated with the meeting minutes. As such, I would expect the NR to come out tomorrow morning. I am very confident the type A meeting resulted in a very favorable outcome for MTFB and I hope the market will welcome the NR with irrational exuberance.
The wait continues....
spike912
Gimme a break my brotha! We are all in this MTFB lottery together yet it REMAINS a TO EACH HIS OWN endeavor. If I or you make/lose money we don't get to share the gains/losses with anybody.
Once the minutes are out, we will have another opportunity to find out whether my theory/my accusations/my claims are well founded. I have no issues admitting to my mistakes/bad judgement.
Yes it's a bold/damning claim and I stand by it. As much I have enjoyed our exchanges in the past, it is with much regret that I decline to further elaborate on what I said today. If you read the entirety of my posts for today, you will find plenty of data points that you can use to conduct corroborative research of your own.
Good Luck!
spike912
Your post below is very well reasoned. I wish you had offered me such a rebuttal to start with because it opens the door for a good dialogue. I am totally in agreement with when you say that the outcomes of the type A meeting will provide clues as to whether the FDA had any legitimate reason to issue a CRL based on concerns about Liver Toxicity.
We shall have an opportunity to revisit my allegations/theory/educated deduction once the NR is out!
Thank you for your considered rebuttal!
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spike912 said:
I would assume that if the FDA simply ran out of time, the outcome of the Type A meeting would be very indicative to that theory ie passed. The fact we have a likely 3 option outcome, none of which appears a straight approval without conditions, lends me to speculate the FDA did review the drug, and, after such review will recommend either labeling, small trial or post approval monitoring (phase 4).
I’m far some saying this won’t be approved but personally and it is imo only, if the theory of “ran out of time” we wouldn’t be in a window of potential approval with conditions/labeling/trials (as per Vox interview).
As I say, only my opinion
spike912
My point was for you to spare me the cautions/warnings (i.e. Be Careful). I don't want to hear that from you or anybody else. If you want to dispute anything I said, please do so. Just as you are entitled to direct cautions/warnings toward me, I am entitled to ask you to redirect those cautions/warnings to yourself. You can make whatever you want out of that. Good Luck!
spike912
Please redirect the cautions/warnings to yourself. This is a BB. Don't come hoping you will factual insider information. That aint gonna happen
I am not making wild assumptions/speculations. I am making an educated deduction based upon various facts.
Once again, keep redirect the cautions/warnings to yourself. Understood?
Ivyspivey
WOW!
MTFB NDA application had more than several hundred thousand pages????? And the FDA is expected to read through it all then render a considered decision within 10 months????? How realistic is that????? Specially when you consider various other NDAs may be under review during that 10 month period.
Truth is FDA is not well staffed to consistently complete its review of NDAs within 6/10 months. Also, timelines to review NDA applications are unrealistic. I believe, the EMEA takes on average 12-18 months to review drug applications.
KEY TAKEAWAY: It's never a good idea to remain fully invested in a pharma company through PDUFA Day. I learned this the hard way at twice occasions earlier this year. This is because there is no guarantee the FDA will be able to complete its review on time to render a rational and scientific decision.
If there were prior discussions about the White Rose Publication, they very likely omitted to use the ASSIST liver toxicity results as a frame of reference.
In the ASSIST trials, some subjects experienced continuing increases in their ALT values even after discontinuing Iclaprim. However in the REVIVE 1 trial, increases in ALT or AST values that were observed during treatment resolved to baseline values upon discontinuation of drug in all patients.
Given that the only liver toxicity issues we are aware of (we, the public) came out the ASSIST trials, it's welcome news that the REVIVE 1 trial offered much more encouraging results on Liver Toxicity.
Thank you for chiming in.
@Citytilidie : Provided my theory is true, it's possible that the Federal Shutdown may have played a role in the FDA not being able to complete its review of the NDA on time. It's worth mentioning however the FDA Commissioner went on the record at various points throughout the shutdown with statements to the effect that FDA was not impacted by shutdown and that it's business as normal there.
What we do know is that NDAs are voluminous documents (more than 1,000 pages by some accounts) and the FDA is well staffed to properly handle the volume of NDA that may submitted on a year to year basis.
It's also my understanding that if the FDA gets in the habit of postponing PDUFA dates, it will be called up to Congreess for hearing. This is because the PDUFA fee paid as part of submitting an NDA is designed to finance FDA's resources needs in terms ensuring the timely review of NDAs. So the FDA just issues a CRL. Who is gonna sue them? Almost nobody!
CLARIFICATION:
When I asserted: "It's documented at various places on the internet.", I meant you will find white papers by various Law Firms floating on the Internet discussion how the FDA issues CRL (as opposed to postponing PDUFA date) when it is unable to complete its review of an NDA by PDUFA day.
It's now clear to me that the FDA issued a CRL because it ran out of time to complete its review of the Iclaprim's NDA. Don't ask me how this is possible? It's documented at various places on the internet.
Based on the more detailed discussion of the safety results from the REVIVE 1 trial (see below), increases in ALT or AST values that were observed during treatment resolved to baseline values upon discontinuation of drug in all patients. MTFB did the same follow-up it did in the ASSIST trials: they run blood work on the trial subjects at various checkpoints: 1) During treatment, or at 2) End of Treatment (EOT), at 3) Test of Cure (TOC) and at 4) follow-up (Late Follow-Up) between treatment groups.
Option 3 is now out of question if you ask.
MEETING MINUTES WILL BE VERY VERY VERY POSITIVE!!!
++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++++
Safety Results
Study drug-related TEAEs, treatment emergent SAEs, and deaths among patients in the iclaprim and vancomycin treatment groups are shown in Table 5. The treatment emergent adverse events leading to discontinuation were 2.7% and 4.4% in patients in the iclaprim and vancomycin group, respectively. An increased incidence of headache (10.2% and 2.4%), nausea (9.9% and 5.7%), secondary ABSSSI infections (6.8% and 3.3%), and fatigue (6.1% and 3.0%), were reported in patients in the iclaprim compared to vancomycin group, respectively. There were no study-drug related TEAE related to nephrotoxicity reported for iclaprim compared to 3 (1.0%; acute kidney injury) for vancomycin. The creatinine change from baseline to TOC was 2.9 and 7.2 µmol/L in patients in the iclaprim compared to vancomycin group, respectively.
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There were (1)***no significant differences between treatment groups in 237 mean values or mean changes in other routine serum laboratory parameters, urinalysis results, vital signs or physical examinations during treatment, or at EOT, TOC and follow-up between treatment groups***.
(2)***Fifteen (5.5%) patients in the iclaprim group, and 10 (3.8%) patients in the vancomycin group had increases in ALT or AST values to >3X upper limit of normal (ULN) during treatment.***
(3)***No patient had bilirubin increases >2X ULN.***
(4)*****These increases resolved to baseline values upon discontinuation of drug in all patients.******
(5) *** No subject met Hy’s law criteria in this study.***
========================================================================================
One (0.4%) patient in the iclaprim group and 0 patients in the vancomycin group had QTcF intervals >500 msec (i.e., 527 msec) or increased by >60 msec compared with baseline. The one patient with a QTc prolongation was not reported as an AE and resolved to baseline values upon discontinuation of drug.
[ Source: Pages 10-11 of http://eprints.whiterose.ac.uk/125867/7/
Good talk!
Have a great weekend everybody! Looking forward to what this coming week may give birth to!
The company should have observed a quiet period between CRL issuance and NR/RNS discussing the key action items from type A meeting. That's how 99% percent of US HQed pharma companies do it. However, MTFB management opted to provide a play by play account of the events.
I have never stated that Companies discussed the details of the meeting prior to receiving meeting minutes. What I said was MTFB knows the outcomes of the meeting. I also said that MTFB is in possession of the meeting minutes. Companies wait for the meeting before providing any definitive update because as the FDA said in its guidance:
Because the FDA’s minutes are the official records of meetings, the FDA’s documentation of
meeting outcomes, agreements, disagreements, and action items is critical to ensuring that this
information is preserved for meeting attendees and future reference. The FDA will issue the
official, finalized minutes to the requester within 30 calendar days after the meeting."
Furthermore, there are legal reasons for waiting for the meeting minutes. Releasing an NR based on the meeting minutes allows the company to quote directly from the meeting minutes as opposed to providing an account of the discussions that might misconstrue what was agreed with the FDA.
To be frank with you, I have very little if anything to learn about how the post CRL process works.
No sure where you are getting your versions of the facts from? You need to go off what the FDA says. What is said in the guidance is rather unambiguous... If you want to disregard what the FDA says, there is not much I can do to help you.
@Jimmybob - This is for you. This is no hear say. This is no " I sat in those meetings". This FDA's guidance. I posted it on May 22.Take a look through it then get back to me.
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 submis
@Jimmybob - This is for you. This is no hear say. This is no " I sat in those meetings". This FDA's guidance. I posted it on May 22.Take a look through it then get back to me.
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
....Assuming the NEWs is good. This is to ensure that the stock price will have 5 consecutive days of trading and of potentially achieving multiple 90 day highs.
If the News is bad, they might as well issue the NR at the close of market this afternoon.
The meeting minutes are in MTFB's hands. MTFB came out of the meeting knowing full well where the FDA stands. Anybody saying otherwise just have not had a chance to do enough research on how these meetings work.
Looks like Traders on Nasdaq are positioning themselves for the pending RNS. Share price is up 6%. Keep in mind MTFB is a very thinly traded stock on Nasdaq. 1 NASDAQ share = 20 AIM Shares.
RNS link below. Next time ... just Google it...
http://www.globenewswire.com/news-release/2019/05/31/1861187/0/en/Result-of-Annual-General-Meeting.html