Thaiflyer1 and Max..
More data is required by the FDA to conform with Hy’s rule(or Law). Which is applied to all new drugs applications for approval after phase 3 trial.
Iclaprim has fallen within the point 1 of this FDA rule but Iclaprim did not show additional evidence of bilirubin rise of more than 2 folds of upper normal level for fulfilling point 2 of Hy’s rule which is detrimental in absolute rejection ,and in fact no raise in bilirubin was detected and all raised liver enzymes went back to normal after stopping Iclaprim.
The number required to be sure is 1000 minimum (motif used 600 patient treated with Iclaprim) to show the risks of serious DILI.
Hence further data is requested to fulfil the safety of Iclaprim through this rule.
No other issues raised by the FDA in their CRL. Apart from requesting more data for potential liver toxicity as explained by Hy’s law (or rule) to be absolutely sure.
These are facts.
All negativities are behind us but only good news are expected with fundings, partnership..etc.FDA meeting , minutes of the meeting with details of required data trial . Expanding applications of Iclaprim in a variety of serious infections and diseases are all positive.
Let’s remind ourselves that the FDA didn’t reject Iclaprim outright but didn’t approve it either due to lack of sufficient data to satisfy Hy’s rule. The CEO should have realised this and be on the safe side to get the number of patients right before the NDA imo. He wasted money and rushed his application and now he has to fund a new trial but should not be a big issue either for the huge potentials Iclaprim has.
Waccy..it was not a joke but reality that if you have lost all your money ...then Foodbank is an alternative..nothing wrong with that ..it is reality not joke...I might go there if I lose all my money too... poverty is not something to joke about so don’t misunderstand me here...
Raised liver enzymes does not necessarily mean liver toxicity.
Such as statins prescribed to patient ,and patients will have to have regular liver enzymes blood tests but statins wouldn’t be stopped until the liver enzymes raised exceeded three folds of normal range .otherwise patient continues taking them with regular blood tests for monitoring.
This is a fact.
Private Ryan...yes I agree the FDA wants more data regarding POTENTIAL liver toxicity but Iclaprim didn’t show liver toxicity in any of its motif trials.
The FDA concerns are because many other approval given by the FDA to other drugs caused later on liver damage and toxicity..hence the FDA is now very cautious on approval on relatively small number trial patients submitted by Motif. The FDA wants more data as they know once approval given Iclaprim will be used by huge numbers of patients.
Iclaprim imo will be approved and funding will be sorted because of the huge revenue it can generate after approval. We are in the last hurdle to get this blockbuster AB approved.
GL and hope you will recover all your losses with every body else.
So if the FDA is not interested then explain why they did not reject it...and why they are having a meeting with motif soon ..may they are bored of doing nothing !...and why the FDA are encouraging motif to carry another trial....
To be quite honest your argument doesn’t make sense..
I am afraid you are wrong here...not all drugs that causes raised liver enzymes raised reverses after stopping them..very wrong.
Look at Paracetamol and read more on all chemotherapy drugs and statins then you realise how these drugs killed patients through liver damage and toxicity even after stopping them.
Efficacy was not an issue by the FDA .
The FDA is simply encouraging Motif to conduct additional trial for extra data to address potential liver toxicity. That is it. Imo it was a stupid decision by the FDA as they could have approved the Iclaprim and asked for post marketing phase 4 trial but we are where we are we need to fund another trial.
If the FDA had rejected Iclaprim outright then I would be here but they in fact encouraged motif to carry on and that is why 19/9 meeting has been arranged as It is obviously clear that the FDA is keen to approval of Iclaprim but wants further trial to be clear of the liver issue above.
If you have any reliable link from motif rns or its trials results or FDA regarding efficacy issue please put here so we can be enlightened.
For anyone not in the know..
Almost all medications we take are metabolised in the liver, and more than half can causes raised liver enzymes and many approved ones cause liver toxicity and permanent liver damages and even death but still are approved by the FDA and currently in use with clear warnings and monitoring on them.
The common examples are statins Recomended to millions of people to take them are well known for their notorious side effects particularly to the liver raising enzymes and toxicity..but recommend to patient to take because of their benefits and advantages in preventing heart attacks and strokes.
For shorters..they need to understand the issue well before dribbling unnecessary fears and rubbish here and exposing their ignorance.
Which documents mentioned Motif trial of Iclaprim causing liver toxicity?
Prove it and send us a link from the FDA response,Motif rns or its trials showing liver toxicity..
I looked through all of them and none is showing what you say here..
Please send us a reliable link not media or speculations.
I am waiting!,
That is why I think the current SP is ridiculously cheap. Iclaprim is in reality a blockbuster AB which can generate hundreds of millions of income revenue once it gets the FDA approval which it has no reason so far for not once the next trial being successful and shows no potential liver toxicity to satisfy the FDA .
Just to rectify that Motif trials did not show any liver toxicity whatsoever and not even a little one!
FDA wanted more data trial to evaluate potential liver toxicity as motif trial phase 3 was low in number around 600 cases and none showed liver toxicity but the FDA is asking for more data to be sure of any potential liver toxicity before approval.
Quite a few shorters here were trying to give impression that the issue was liver toxicity which is not.
again you are wrong and your short positions are burning and rightly so.
The Iclaprim was not rejected by the FDA but they encouraged Motif to carry on with additional trial data before approval.
Your tactics are not working....Try harder next time .
Imo...perfect time to add more here..
No chance of going bust.....blockbuster AB with its dire needs in many health conditions with many interested parties including usa health institutional recent funding
Share upside in big way is coming.
Holding just over 2m shares .
Bina Bawi oil will come fairly quickly on stream then Gas to be funded from oil revenue...miran later.
SP will accelerate upwards ....KRG,KRG,KRG..is where the delay with their political complexity.
G is now very strong and underpinned well by many factors including dividends and pile of cash.
The new ceo is making good progress with more visibility in the horizon in his future expanding growth prospects.
All is good...and hoping op will nudge up further.
“if you have an open short position in a company that gets delisted and declares bankruptcy, then you don't have to pay back anyone because the shares are worthless. ... Eventually, your broker will declare a total loss on the loaned stock, and your debt will be canceled with your collateral being returned.”