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Spectral Medical Inc T.EDT

Alternate Symbol(s):  EDTXF

Spectral develops devices for unmet medical needs. Sepsis occurs in 1.7M Americans/year causing 250K deaths, often caused by endotoxin. Our devices measure and remove endotoxin from the bloodstream. An FDA confirmatory trial is underway. Dialco, a Spectral sub, offers SAMI, a novel instrument for renal replacement, cleared by FDA. Dialco is seeking FDA approval for DIMI a unique home dialysis enabler. These devices have large commercial potential


TSX:EDT - Post by User

Bullboard Posts
Post by Diamond482on Aug 04, 2015 1:47pm
121 Views
Post# 23987628

Were coming around the corner ...........final stretch !!

Were coming around the corner ...........final stretch !!
Spectral Medical will continue to submit ( PMA ) pre-market approval as stated by the company in Febuary and again in April up to and including the end of the 3rd quarter which puts us at the end of Sept. ( There is NO EAP ........... that was one of our infamous monkey posters pipe dream ).

The SAP ( statistical analysis plan ) should also occur between somewhere between now and then ........... but either way we are at or near the end of Sept. 

THEN .... factor in paper shuffling ...... optimistically 2 weeks ?  The either of those submittions will take the FDA ( typically ) 50 some days to do the analysis.  That puts us into approximately early to mid December. 

We will then get either ........... an early FDA approval as predicted by Spectral itself. OR ... a re-calculation to the end of the study into late next year.  Analyis give us an 80% chance of success at that point and they can say they were right and we go to market in 2017.

OR

we get the early approval ...... and we get rewarded and Santa comes early.

SO ........... we are about 12 to 16 weeks away which goes by in the blink of an eye.

In the mean time ......... the submittion for the pump is occuring aswell ........ which ... I'm a bit comfused about .... I must have read something wrong .... I thought we were looking at FDA 510K approval already.  I looked back and could not find were I had that impression.  I'm still convinced the approval was slotted for now ... but I guess not.  The pump itself is fairly advanced ....... and to me ........... that alone is worth 3 bucks a share.  So ... as in the past ... the low pps at this point baffles me.  But ..... it continues to allow me to accumulate and get wicked deals on the shares.  IMHO ... keep buying at these rediculously low prices while you can.
Bullboard Posts