Opsens Inc T.OPS

Regarding the 2 questions of the FDA

[ivebeenthere]

After reading the questions on this site of different investors about 
not knowing if answers were sent to the FDA.
So yesterday afternoon i decided to send an email To Mister Louis Laflamme
asking if those questions were answered and if yes when.
I just received his answer: The questons were answered in the beginning of august.

So get ready for liftoff !

[ddogold]

Thanks for the update . Excellent news . Might explain the steady price appreciation and volume uptick . In Louis we trust . GLTA 

[Dogsbreakfast4U]

  I am surprised the CEO would have shared this with you directly in an email within 24 hours without the investors relations staff getting involved. 

[ivebeenthere]

Send me your email address by private message ill be glad to transfer the message i got from  Mr Laflamme.

[Dogsbreakfast4U]

Thanks for the email chain between you and LL

[CriticalCare]

Hi all, Interesting and worrying, that LL answers you with such precise information without disclosing this publicly. This is privilege information, The FDA 510(k)  process is very clear and counting the review days giving you a good window for an answer from the FDA,    If they sent the additional information package to the FDA befining of August they have received another set

[ivebeenthere]

When one ask for FDA approval its certain there is going to be questions to answer to in timely manner.I dont think that saying to someone that they answered  those two questions is privilege info because everybody knew beforehand that questions will be asked .What would have been privilege information is if M. L would have told me that they were not able to answer those questions. Glta

[bossu]

Quite an elaborate explanation. Plain and simple :my understading is that the back and forth ''questions and anwers'' is complete and at on point the FDA has a final delay to state on the product for a ''go-no go'' approval .They have up to 60 days for the decision but when did the ''clock''begun to run ? Most probably ML has the date of the

[Possibleidiot01]

I wouldn't mind seeing it as well . PI