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Cont.....
And perhaps this why GL in his latest webcast was more optimistic of clearer path for FDA approval and what he meant all bases were now covered ...to our dislikes of his attitude and optimistic tone despite FDA decision !!

Just looking into Iclaprim failure to get FDA approval and Arpida collapse in 2009 ( to be accurate Arpida was taken over by another pharma but shareholders got basically nothing).
The reasons of rejection for Arpida then was very different from MOTIF as in Arpida case was about efficiency “The analysis showed that iclaprim was less effective than New York-based Pfizer Inc.'s Zyvox (linezolid), which conflicted with the results released by Arpida in July 2007 and December 2006.
The FDA analysis showed that Arpida's Phase III studies comparing iclaprim with Zyvox, known as ASSIST-1 and ASSIST-2, failed to meet noninferiority to the prespecified margin of 12.5 percent.
The lower bound of the 95 percent confidence interval for the treatment difference of the clinical cure at the test-of-cure period between iclaprim and Zyvox exceeded the FDA's determination of the noninferiority margin of 10 percent in most of the intent-to-treat and per-protocol co-primary analyses, the agency's drug reviewers stated.
In addition, the upper limit of the 95 percent confidence interval for the treatment difference failed to cross zero in ASSIST-1, the reviewers said.”

The FDA approval to any new drug Application is based mainly on efficiency and risks of side effects to tge patient though their approval is more on the efficiency than the risk of side effects when the needs of new drug is necessary and urgent to save lives.

In MOTIF case the FDA did not reject Iclaprim outright as it did in Arpida case ( due to lack to efficiency in comparison to other available drugs then) BUt in our case.with MOTIF the FDA asking for more assurance and data about side effects and not about efficiency as in Arpida case (which is far more relevant to the approval process).
In reality MOTIF path of approval is clearer and would be achievable if they can raise the funds required to acquire further Data in another trial. The risks of side effects to liver toxicity would not be a big issue for the FDA to approve Iclaprim if these risks show to be manageable or low or transient. There is no doubt that MOTIF has proved Iclaprim efficiency in comparison to other available drug such as Vancomycin which is showing growing resistance and kidney toxicity and the need-for a new drug like Iclaprim is more urgent.

The big issue is now for MOTIF is to raise the funds to achieve FDA approval and I believe this will take place.
I am holding tight as I feel there is a path for FDA approval with Iclaprim under MOTIF and it is in a very different position from Arpida.

Morning all..
Some great posts today putting their views in different directions of this company..
There are many other companies when their sp tanked and recovered or started to recover fairly quickly such as fxpo when their sp reached in the 20s p and recovered few years ago and recently Faron pharma and So on.
Mtfb is not an exceptional and necessarily dead in the water .
I entered at 3.38p level and was not a holder before and do feel sorry for others who did see their massive paper loss when the share lost over 90% of its value and we all or most had experienced this disastrous result in one of their stocks market investment specially with aim shares.
I invest mainly in these kind of shares but after looking into risk/rewards balance and bod backgrounds,ii investor position and who are the majority shareholders including private eq investors. In case of motif the public investors are about 16% only for example. The rest are ii and private eq.who are known with their microscopic investigative attitudes before investing in any company. They are all still holding and not selling.
If motif is going to fail to recover then we would surely see a different language in the recent update,webcasts and no new appointments or partnership with other institutions and the company goes under. Then for investors who were subjected to huge paper loss now..what would they get if they sell now,,,very little so what is the point of selling and why not wait a-bit longer ...sp cannot go below zero!!
I think myself we have touched the bottom in sp and we will witness up stick next week and obviously more volatility.
I feel mm are tree-shake the weak investors to reach to the lowest sp to maximise their profits.
The mtfb is not for the faint hearted and needs nerves of steel. I do not recommend any advice here but I am inand holding for now.
Anger and frustration are understandable but patience is required now.
I think here was a massive over reaction and pi was spooked and many sold at big losses sadly or saved themselves the last few pounds....only time will tell.
It is only my view and I accept other views too as I could be totally wrong but it is my decision and it is my loss and this applies too on others who sold and believed mtfb has no future and will go bust....it is what it is now and entirely up to individual how tgey want to think about mtfb future.
GLA

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