Hm - so why this company dont do this before FDA meeting ?
The company must raise capital, and it quickly if he wants to talk about research!
But if even that will do it for my taste is mismanaged!
Yes, there are a few positive things - the world championship in sales
and raising capital-only meager results!
Recent operational costs too much talking!
You know it looks a bit silly but - with one of strontium and management is very cool - / take money ands selling - on the other hand has nothing to sell - I do not know if it had anything to sell this in a calm-
need to change industries-buy supermarket! /
The fact that the drug is safe and effective is not questioned by the FDA... if they had any doubts they would have asked for more clinical trials and they wouldn't apporve PLX to treat over 100 patients in the U.S. The issue that put this approval on hold is the total similarity requested by the FDA in the chimical structure of the drug in its manufacturing process. The fact that PLX can manufacture the drug in very high degree of chimical similarity is not enough. The FDA wants to get the highest degree of similarity, although there is no known connecteion between this similarity and the safety and effectivness of the drug. This is a precausion meassurement taken by the FDA in most cases but in particular with this drug which is based on a different technology. I was told by an expert in this field that PLX reached a very high degree of similarity, a degree that normally would be sufficient and even more than that but the FDA asked for more...The apparant reason for FDA request is due to the fact that there is no similar information that can be compared due to the fact that this is a uniqe technology... I was told that PLX should not have a problem to reach this highest degree but it is a process... this is not a one day issue... this involves more laboratory work and deeper chemical analasys of this drug...You can compare FDA's request to several formalities that exist in various fields which are all just a precausion request sometimes with no reason behind it...FDA is confident about this drug but sometimes in order to approve it you need to go an extra mille....I was given example of other drugs that had the same issues with FDA all of them were eventually approved... when this drug is approved it will be the 100% recognition of this technology! now we have recognition only by the fact that it is working but when PLX will be able to demonstrate the highest degree of chemical similarity this is going to be a strong win!! therefore' it does not matter if the stock is 5 6 or 4... if I am certain like I am that it will be approved we are talking of a 30 and 40$ stock... there is no way back here... the Maraton runner has last 200 meeters to go... he will do it even on his knees!!If you want to get a simple example about what I am talking think about an Advil pill. When you take it after it is in the box one year or if it was exposed to the sun or even after its expiration date it will still work but its chemical stracture may be different due to these changes- this is what basically we are talking about : changes that have no direct effect or known effect on the drug.