focusIR May 2024 Investor Webinar: Blue Whale, Kavango, Taseko Mines & CQS Natural Resources. Catch up with the webinar here.
another useful quote below
Think they have the partnerships in place but all depended on Approval to secure
best deal hence was a big shock to BOD.
Without knowledge of exactly what liabilities may be due it is hard to predict exactly how long the cash will last. Maybe they have to pay another PDUFA fee to FDA to resubmit( they had a waiver last time) I simply don’t know.
The cash burn of Salary and routine admin is relatively low hence why I am not unduly calling for salary sacrifice.etc.I am surprised by lack of contingency plan and not sorting funding out prior to CRL simply to keep options.
Also the timeline of FDA meeting is outside their control so for eg what happens if Trump causes another Govt
shutdown.
That is why I am reasonably confident they will raise before meeting
More debate for anyone interested quote below
What I do know is this is not a lifestyle Company simply spinning out the timeline to continue to benefitfrim their current employment.We don’t know the exact FDA concerns but let us look at what we do know or can reasonably assume.
1.It appears that apart from the dramatic dumping by Invesco and M&G on the day of the CRL which forced the price down to 5p and again the evidence is that it was purely as a result of their risk mitigation rules rather than their investment side.The institutions appear not to offloaded any more.A big positive.
2. The CRL highlighted additional data on liver toxicity.We don’t know what this entails but look at what it did not mention.No mention on efficacy,no mention on any cardiac safety or on any CMC issues.So again big positives over what happened with the Arpida submission in 2009.
3.FDA will approve if drug benefits outweigh risk.I am pretty sure this will be case for Iclaprim but may involve a labelling change,warning or more post marketing surveillance all of which you can still get Approval.
4.We know there were several interested parties I doing a commercial deal.
So the choice is have FDA Meeting and raise or raise and have FDA meeting.You can put the main expenditures on hold and I don’t think they will want to take this to the wire by having FDA meeting first unless they simply can’t get the raise.
So to me they will attempt to raise first and support of existing institutions is critical so they must have soothed their concerns in short term.MTFB will know the likelihood of what is needed to satisfy the FDA requirement and the actual meeting will just be to confirm the pathway forward imo.
I believe they will announce the financing before an FDA meeting and that is a huge clue as no one will support unless they believe there is an extremely good chance of success with FDA and MTFB will have to give more detail on the precise nature of the concerns raised in the CRL to these institutions and they will have internal experts to assess this detail.
So radio silence from BOD and then newswhen it Is finalised
quote below for anyone interested in debating the crl further
I had a good look at the paratek Phase 3 results, oasis1 and 2 and they did seem to present a lot more detailed data in the published version available on the net. They had the same raised liver enzymes with their drug but perhaps presented more data to show safe and got a straight approval.
Im sure motif have all the data in patient records of those who had elevated ast/alt levels. The fda need to be abvsolutely sure this is safe before they approve and allow on the public.
As an example is it acceptable to state - "all raised levels returned to base line" - or should full full data be provided on those patients effected and their monitoring through the raised enzyme period and the time taken to return to base line. Blood/heart/liver/breathing monitoring before during and after.
It is looking great here today, good luck :)
Thank you Four, same to you :)
Hi Four - I wish I was invested in motif also, I don't have that many funds I'm afraid, just starting out really, in my first few years of trading! They are posting a lot of research and debating on there so I am feeling encouraged and hopeful. :)
I have seen other boards where there was a single poster and then the price rise comes and people start to post again and the debates kick in, so I will remain hopeful - quote below
A former regulator colleague commented to me that given the small safety database for iclaprim versus established ABs, the extra data requested could just be a bit more follow up on the patients who did have raised liver enzymes. If so that could be good news.
You are well researched Ian.B thank you for keeping us all informed and helping, :)
Further research to help us understand and continue the debate quote below
Repost of my notes of liver data DR H presented on conference call - by way of comparrison---
I have made detailed notes listening again to the CC of Dr HUang, Liver tox presentation - Bio included before detailed res
David Huang, M.D., Ph.D, Chief Medical Officer
Dr. Huang is a senior pharmaceutical research executive, and the former Chief Medical Officer at ContraFect Corporation. Dr. Huang also led a drug development group in anti-infectives at Pfizer. Dr. Huang has over 15 years of clinical, academic and research experience in infectious diseases. He has served as a faculty member at Baylor College of Medicine and currently as an adjunct Assistant Professor at Rutgers New Jersey Medical School. He continues to see patients at the Veterans Affairs Medical Center in Houston. His research interests include bacteriology and virology, especially the epidemiology, pathogenesis, and treatment of multi-drug resistant organisms. He is experienced in designing, executing and closing out Phase I – III clinical trials for both antibacterials and antiviral agents. Dr. Huang completed his medical school at the University of Texas at Houston Medical School, and completed his internship and residency in internal medicine at the University of Texas at Southwestern and fellowship in infectious diseases at Baylor College of Medicine. He is board-certified in both internal medicine and infectious diseases.
Dr Huang -
R1 & R2 -
15 (5.5%) patients in Iclaprim group
10 (3.8%) patients in Vanc group
Had elevated Amino transferase (Ast/Alt enzymes) (1.7% difference)
Those are patients at least 3 times upper limit of normal.
No patients had BiliRubin increases greater than 2 x upper limit of normal.
Note -(Bilirubin is produced by the liver and other cells in the body as they break down the red blood cells, in particular the haemoglobin component.
Bilirubin then drains from the liver in the bile through the common bile duct into the upper part of the intestine.
Higher than normal levels of bilirubin in the blood suggest that either larger amounts than usual are being produced through unusually high levels of blood breakdown called haemolysis, or that the normal drainage of bile containing bilirubin is being prevented.)
No patients met HY law criteria in R1.
(Hy's law is a rule of thumb that a patient is at high risk of a fatal drug-induced liverinjury (DILI) if given a medication that causes hepatocellular injury (not cholestatic injury) with jaundice. The law is based on observations by Hy Zimmerman, a major scholar of drug-induced liver injury.)
In R1/R2 -
11 patients 3.7% In Iclaprim group v 9 patients 3.0% in the Vanc
Had increase in AST/ALT 3 x upper limit of normal
Note in R2 - Outbreak of Hepatitis A - 1 in Iclaprim group and 2 in Vanc group.
2 of these had Bilirubin levels greater than 2 x normal (1 in each group)
No study in R2 met HYS law cri
There are some very well researched posts coming through quote below:
Yes parateks drug Omadacycline was approved with there phase 3 trials oasis 1 and 2 results both showing increased Liver toxins - taken this form their P3 Results -
The liver safety findings are summarized for the pooled data from the 3 pivotal Phase 3 studies in ABSSSI and CABP. Overall, 5.4% of omadacycline patients, 4.9% of linezolid patients, and 7.2% of moxifloxacin patients had hepatic AEs of interest during the pivotal Phase 3 studies. The incidences of all hepatic AEs of interest, including increased ALT and increased AST, were similar between the omadacycline and comparator groups. In the omadacycline group, all hepatic AEs of interest were mild or moderate in severity, except in 1 omadacycline patient who had a severe TEAE of hypoalbuminemia. A total of 5 patients had hepatic TEAEs that resulted in discontinuation of test article, which included hepatic failure following a cardiac arrest in
1 (0.1%) omadacycline patient (serious TEAE; not related to test article; event resolved on
Day 29), and laboratory-associated TEAEs (eg, AST, ALT,) in 2 (0.2%) omadacycline patients and 2 (0.5%) moxifloxacin patients. All hepatic AEs were either resolving or resolved without sequelae during or following completion of treatment, except in 2 omadacycline patients (TEAE of ALT increased which was considered mild in severity in 1 patient and not related to test article and TEAEs of ALT and AST increased which were considered mild in severity and not related to test article in another patient). Although these patients were considered recovered/resolved with sequelae by the investigator, no additional AEs of sequelae were reported.
The incidences of post-baseline elevations of ALT or AST by 3 × ULN, 5 × ULN, and 10 × ULN with omadacycline were similar to comparators in all patients (Appendix Table 54, page 111), patients who had normal values at Baseline, and patients who had abnormal values at Baseline. Increases in total bilirubin to > 2 × ULN were similar between treatment groups.
Elevations in ALT and AST were mostly asymptomatic, transient, of low magnitude, resolved following the completion of therapy, and did not result in discontinuation.
No patient met the criteria for Hy’s law as defined in FDA guidance.61
The use of tetracyclines has been associated with hepatic AEs, characterized, in general, as low frequency and low magnitude elevations of liver enzymes. The effects of omadacycline appear to be similar to that of linezolid and moxifloxacin and older tetracyclines.62,63 Hepatic AEs occurred at similar with omadacycline compared with linezolid or moxifloxacin treatment and treatment discontinuations were infrequent. Elevations in liver enzymes observed in patients who received omadacycline were generally asymptomatic, of low magnitude and transient (ie, reversible to baseline values during or following completion of treatment).
Thank you Ian.B appreciate your post :)
Further evidence of hope for approval quote below
I believe Paratek encountered higher AST/ALT levels during their P3 trials with omadacycline and received FDA approval?
If I had any spare funds I would have bought here yesterday, but currently I don't so I will sit this one out and watch. Well done to you all as you are up today and good luck :)
If anyone is hopeful as I am about reaching levels before the 13 feb then do not worry as there may be hope, quote below to keep up spirits and continue the debate.
you may well be correct about the subset info as these numbers are so small they are unlikely to be statistically significant so depends a lot on whether MTFB wanted a clean a label as possible and that what additional data is required.
We simply don’t know and also what biomarkers are available if any to predict which patients are likely to developedvrsused AST and ALT levels.
Crucial thing to me is no permanent liver damage and enzyme levels returned to normal as the liver is the most regenerative and responsive major organ of the body.
It may be that a simple labelling change can allow Approval in the future...
Well kettle - It is a shame that after being caught out you cannot even apologise like a gentleman so you have used derogatory language before the apology
if it quacks like a duck...... My apologies for any offence.
If you spoke to any self respecting woman like me, then you would probably get a more animated response!
I have no idea why you have chosen me as someone to question. I was in WSG for over one and a half years, I didn't trade as I had put my money in at once. I then followed 2 people from that board who are on this board and also posted on Amp, I decided to take my holding out of wsg and put it into Amp as I thought Amp would give me more profit as opposed to the already high price that mtfb was. I did this as a punt to increase some money as I had lost a bit in wsg and had waited far too long for nothing to materialise. I should not have to prove myself to you or anyone. Now after waiting one and a half years in wsg I am heavily down in Amp and on top of that you have chosen me to pick on! Don't you think I have had a difficult enough time as it is without having to now justify myself to you! I have just as much right to post as anyone else. I was very polite to you when you posted on Amp even though you did not have my view, I showed you respect and because I did not agree with you, now you are concluding that I a new poster who has been honest and frank, am some kind of conspiracy theory who is trying to get Amp whatever you mean by this. I am not going to go back and forth with you like this. So I would really appreciate it if you just took a deep breath and let me be.
Thank you Ivy :)
Indeed they could become very valuable, fingers crossed. That is why I chose Amp because of this point exactly, I thought it had more options. Evidence why some believe mtfb is being held down currently quote below
I posted others to get IG quotes ( as they are RSP driven unlike you big standards brokers) to show what the real book is.
And to sell 500k it’s always close to the bid - 3pc.
The ask, that’s the joke - varied from 23.5 to 8.95 throughout the day. Check out the CPX example for normal mm quotes.
And ignore auto volume- neutral.
So was your ultimate judgement right but a kink in the road. Up to you mate, but all is not well in the state of Denmark.
Forecast for tomorrow . Bid will drop to 6.5p about 2 mins after opening and 3 mins later the bid will pop back up.
Etc etc.
Then at 2.30, botty activity to slowly drop and a gentle close downwards ( with a UT at 7.2)
They will bore the pants of traders.
I posted others to get IG quotes ( as they are RSP driven unlike you big standards brokers) to show what the real book is.
And to sell 500k it’s always close to the bid - 3pc.
The ask, that’s the joke - varied from 23.5 to 8.95 throughout the day. Check out the CPX example for normal mm quotes.
And ignore auto volume- neutral.
So was your ultimate judgement right but a kink in the road. Up to you mate, but all is not well in the state of Denmark.
Forecast for tomorrow . Bid will drop to 6.5p about 2 mins after opening and 3 mins later the bid will pop back up.
Etc etc.
Then at 2.30, botty activity to slowly drop and a gentle close downwards ( with a UT at 7.2)
They will bore the pants of traders.
SETs is supposed to be more liquid and better prices ; normally correct.
Yet here, SEAQ is far better priced on comparable shares. Check out more to validate,
As ever, always ask WHY? There’s no such thing as random - just humans
I couldn't buy and they did it so fast. At one point couldn't buy any and did a fok at I think 7.3p. So manipulation was on yesterday. Also noticed when a buy came , they would have AT SELLS KICK IN. If no buy or sell they were happy to do Jack. So implies sp being controlled in a range until placing done?
more food for thought for anyone interested quote below
Anyone got any thoughts on why AMP has held up so well.
I was expecting them to be a total right off
However they are only back to where we were when we were in the early 30s
Fro a risk return basis AMP has been a better share all round
Higher multiples of growth on positive news
Less of a fall on negative news.
Unless The manipulation theory of motif is involved
Indeed because mtfb are at 7p currently it puts Amp in that position, but some people believe mtfb is being held down, and in any case they are due news on fda meeting etc which will change current mtfb share price. If there is positive news flow from mtfb and that price gets back up it will change the situation here. Once mtfb get above a certain point more people start to buy Amp again as there is a chance of better returns as our price is much lower than mtfb. So I have my fingers crossed that it will be the case. We also have to remember that mtfb have acted fast in terms of finance etc. quotes below to ponder from mtfb posters
They have already proved they will aggressively manage the finance, already with the early loan repayment
The SP rose in both AMP and MTFB for a few weeks, the reason being that people start buying in before news due, in this case the FDA decision. Probably more people exit just before the news to suit their risk appetite and to take an easy 20/30 percent without any further risk. The same will be repeated again once the FDA date comes