Biscuitpants
Posted - 3 hours ago
$MGRM Comment n last post: The hidden message in NOTHING'S GUARANTEED??? I think that the CEO believes that he EXPECTS the FDA to take a favorable position on MGRM's proposed testing plan.....see meaning of NOTHING'S GUARANTEED below:
Nothing is guaranteed" essentially means that you can't be certain about any outcome in life, and that UNEXPECTED events can happen at any time, so you shouldn't take anything for granted.
Biscuitpants
Posted - 3 hours ago
$MGRM CEO from Q3 CC ...
"We expect during that meeting (the upcoming planned December FDA meeting) we will get a lot more clarity on whether our proposed testing plan will fully address all the FDA questions and that we're thinking this will be a really critical moment for the company in terms of derisking the application. Obviously NOTHING'S GUARANTEED, but it will certainly be helpful to have a conversation with the FDA for more clarity."
Mptxop
Posted - 3 hours ago
$MGRM
Biscuitpants
Posted - 1 day ago
$MGRM Comment regarding previous post: MGRM provided written responses regarding the FDA's Additional Information Request (AIR).
MGRM thought through how they wanted to address the appropriate testing in cases where they thought appropriate testing would be needed. The MGRM proposed testing does not include OUS clinical trial data. It is believed Monogram is hopeful/expects that an OUS clinical trial will not be needed as part of the NDA application but does NOT want to assume the FDA will agree to such a proposal.
If the FDA would like OUS clinical trial data, then (as CEO) stated, we have a plan to get that data very quickly.
Biscuitpants
Posted - 1 day ago
$MGRM Takeaway from the CC....CEO stated.....
MGRM received comments related to the AIR that stated the FDA did not specifically recommend testing, but made comments that could be inferred to be recommending additional testing.
"We have a belt and suspenders plan to getting clearance (OUS clinical trial).
If events go great in the December Sub-Q meeting with the FDA and they feel that clinical data is not needed with the application, that's terrific. If the FDA wants clinical data, that's okay as we have a plan to get that data very quickly."
Buttass
Posted - 1 day ago
Growth101
Posted - 1 day ago
$MGRM anybody listen to the CC?
Biscuitpants
Posted - 3 days ago
$MGRM There is a MGRM CC tomorrow after market close ...hopefully MGRM will clarify milestones/timelines related to the planned clinical trial of 92 patients in India....it would appear from the excerpt below that before a trial can begin in Inda that PROOF OF APPROVAL is needed in the manufacturers home market.
According to India's CDSCO regulations, a surgical robot would likely be classified as a Class D medical device, requiring the highest level of scrutiny and would necessitate proof of approval in the manufacturer's home market to facilitate registration in India
Buttass
Posted - 3 days ago
$MGRM Getting in early on a cyberpunk company. 20 minute knee surgery would be absolutely insane.
rossm9
Posted - 5 days ago
$MGRM I don’t post anything, ever… I can tell you this. I firmly believe this is a great product that will enhance the lives of everyone it touches. It is going to be a several year hold though. I will continue picking up shares as we go. Good luck to all those doing the same!
Mptxop
Posted - 6 days ago
$MGRM Them not disclosing what the FDA wants is concerning? US trails could cost lots and time.
Mptxop
Posted - 1 week ago
$MGRM I transferred some funds to buy under 2$ I hope it clears tomorrow since it’s under 3$!
Growth101
Posted - 1 week ago
$MGRM I don’t think management cares at all about stock price or investors
GoldPannin
Posted - 1 week ago
$MGRM SUPER DUPER bullish!
coreholder
Posted - 1 week ago
$MGRM Q3 earnings announcement should be this week!
Mptxop
Posted - 1 week ago
$MGRM Getting closer to my buy more price of under 2$!
skipperdr
Posted - 1 week ago
$MGRM I’m adding to my position as longs as it’s under $2.30.
Boxcar66
Posted - 1 week ago
$MGRM nice
coreholder
Posted - 2 weeks ago
$MGRM lol 😆 trading all over the place today
coreholder
Posted - 2 weeks ago
$MGRM Nice after hours action
Buttass
Posted - 2 weeks ago
$MGRM Took a position at $2.28
coreholder
Posted - 2 weeks ago
$MGRM Bullish on this company’s future
snapbuy
Posted - 10/25/24
$MGRM will this ever burst?
Gino2186
Posted - 1 month ago
$MGRM these dividends arent looking to bad. im glad i held.
coreholder
Posted - 1 month ago
$MGRM nice breaking out of support range
Princeb
Posted - 1 month ago
$MGRM anyone get an email that preferred shares were converted to common? I got an email 10/15 that it was converted without my authorization
Baabboon69
Posted - 1 month ago
$MGRM
LowT
Posted - 1 month ago
$MGRM $120K purchase this morning. Something is definitely brewing this week 💎🤚
RemitTekram
Posted - 1 month ago
$STXS This is looking pretty strong here. Have to be in robotics surgery. Going to happen! $MGRM may be a good one too. Their collaboration with nvidia will only help their design.