....You know, the only thing that really bothers me about the up-coming filing is that it appears that the FDA can/will give out a CRL for the smallest of issues and the last few that I have looked at lately seem so trivial... Why doesn't the FDA take more of a "helping" stance vs blocking opportunities. I understand a rejection or CRL if there is a major issue, but not something very small and stall a company/drug for 6-12 months again. I make this statement more in relation to the overall approval process and not necessary in relation to KERX (other than the fact that KERX will be subject to the FDA’s whims very soon.)
Zerenex is very simple well known compound, it is iron, why would FDA have any problem with it?... FDA approval is sure bet, I thought long and hard about it and I don't see any risk here....and keep in mind all the cost savings the Z will provide...we just have to be patient, time is on out side
No - I'm not. I did "accidently" sale my shares at $8.60 (I had a limit set and did not think that it would go that high as quickly as it did), but bought back a few thousand shares between $6.54 and $7.50 and plan on holding those shares - this is much smaller than my original investment but I took my other profits to another bio that looks very interesting. I do not short any stocks and never have. I do try to be very realistic though...
It will be nice to get some info about the filing in Japan, but this along will not tell us how the FDA will act here in the US. The only thing that I can think of that the FDA may have any concerns with would be something in the manufacturing – everything else we have seen and looks good.