Jottings gleaned from conference:
Carter: less focus on contract manuf. but pleased to use there capacity. expect revenues to back on line, concerning naltrexone
is experience and increased competition, pick up in orders presently to late to effect sept.Q. committed to naltrexone product. earned a higher gross profit from less revenues.
r+d expenses more, r+d more important to see what is being done!
more peeps working, labs being used more, made more batches in dev.
increased product development, using our facilitys.no issues for shelf life. series j nor warrents will never, ever require cash payments. not convertible for another 3 years! We are compliant!
Mr.Hakim: we expected lower revenues , but we will have better results.
facility warning letter: fda said we addressed all issues, only thing left is for them to give us green light letter! it is in process! IT IS JUST A MATTER OF TIME, HOPEFULLY 3 MONTHS OR LESS
WE DO COMMUNICATE ANYTHING ELSE WE CAN DO FDA NO, JUST WAIT,
NO HOLDS ON ANY THING WE HAVE FILED.NO ISSUES WITH FACILITYS AT ALL. PERC/NORCO CRL LETTER WE DID EVERYTHING THEY WANTED
UNDISCLOSED ANDA GOT ASKED A QUESTION LAST NIGHT, WILL respond
with in 30-days
sungen: ANDA APPLICATION THIS year meaning dec.
sales and marketing go it alone but will not be paid immediately
6-12 months need working capit. partner will have sales and marketing team this is way they are leaning,we have numerous products with sungen would make sense to do it with them overall
no decision.
we raise money for r+D PERIOD, GUYS ON IHUB RIDICULOUS WITH FAKE NEWS. 0.152 EXCISE PRICE ON SERIES j ? RATCHET OF 100-MILLION SHARES , absolutely incorrect! No ratcheting for linc.park,warrents or series J got it guys on ihub?
generic perc. what is time line? would take 2-3 months, have to
figure out the jv,alone, sungen etc. How promoted have to figure
out distribution. He will pursue first product to be approved
fda time, green light on fda time, fda time
sequest ox:top priority for us! countless hours in labs all positive, we will do be if we have ducks in a row by june2018 we are on the right track . Our technology is solid, no fda issues with technology it is ALL WITH THE LABELING. sequest ox will open
the door for us but got to do it right.must do invitro carefully
we will get there for be patience.
pfizer waiting for them to launch, 3 years exclusivity for pfizer
warning letter since 2016 no effect on us,, we can think about nothing else we have to do? warning letter has been addressed, inspection no issues, Lab, manufacturing suite and warehouse
all to be put on web site SNAP THOSE PICTURES.
tmax issues key when ever fat meal given tmax took longer, variation in the product depending on person consuming it, historically they gave 2 hour before 2 after this is our problem
fda wants us to fix this issue, label,label,label, is fda's wall
for us! he is confident we will solve it the next few months in the lab.WE NEED TO SOLVE IR ISSUE WITH SEQUEST, FIRST AND THEN OPEN THE DOOR TO OTHERS, PFIZER REFUSING TO LAUNCH COMPARATOR!
anda filing for dec. with sungen on schedule
vision:
