one more thought. you believe that fast tracked or priority review is a given upon approval of NDA ? correct ... Yet, cant they deny fast track if submission needs work
thanks for reply. So what happens in your best estimate if they don't accept NDA as submitted. I assume MGMT then needs rework and resubmit thereby pushing out dates another 6 months and hello 20's ? is it common place for NDA to be resubmitted.
Do we get a major sell off ? I was thinking we might go down a few points then recover quickly ?
for chartist if you review the previous sell off to low 5's back in late August you will see some high volume days thus highlighting existing investor enthusiasm for the space. Yet the most recent sell off is not being bought up thus you can see how I drew my above hypothesis on the tape. As, my mentors always say follow the volume as its speaks to the tale of the tape.
I believe that this new emerging space has lost its sex appeal for the moment which is not uncommon
among new emerging breakthroughs the main driver is just the macro cloud over the BIO space the 2nd and more important is that once the shine wears off a breakthrough science as the investor community changes the paradigm to OK we love what you got cooking now show the money. Thus, both BIOC and TROV will now be guided in PPS by revenue growth , less earnings more top line. As, we all know they will have to reinvest money back into sales and marketing for years to come. Yet, my point being TROV is now less about hype and more about creating a real going concern.I also believe that BIO space investment dollars are moving into companies closer to large scale commercialization and real revenue or the CELG and GILD of the world that are showing significant value after this pullback. My hunch based on the macro picture of the BIO space, anemic volume in the LB sector and my recent understanding that its all about Medicare lead me to conclude that TROV will float between 5 to 8 pps until it can show real revenue.
i get it. but just make sure you understand real time is referring to biomarker point of time not the review of data collected via sample.
Per BIOC presentation on Friday my takeaway was this its going to be all about MEDICARE reimbursements to get wide adoption and sizable foot print. I had not thought about this until I heard the presentation. BIOC indicted they would need more data to substantiate benefits. Perhaps this one reason TROV is spending so much resources collecting data and beta rollouts at hospitals. If you think about the lions share of potential patients must be eligible for medicare. At least that's the situation in my family which is no stranger to cancer. be interesting to see how this unfolds. i posted a tad more of my opinions of the BIOC board.
MEDICARE reimbursements is going to the KEY in finding success. BIOC spoke to it in presentation on Friday. He indicated they will need more data to substantiate benefits ( my words not his ) If you think about it Medicare patients must be the lion share of the market ( age demographics ) Be interesting to see a pie chart breaking down the ages of potential patient opportunities by age. I tend to believe based on witnessing the effects of cancer in my family that it tends to be more frequent after the age of 65, Thus highlighting without medicare reimbursements the market opportunity is substantially decreased. Regarding BIOC presentation I thought it was informative but lacked any financial data to forecast sales. As, they have been very quiet about projections , etc. I´m surprised by the streets response or lack there of to the BIOC story. I believe it could have to do with being a sub 5 stock as most funds cannot invest in shares lower then 5 as well BIOC admitted missteps in the roll-out by MGMT. TROV seemed to become the darling of the space whether deserved or not. Nevertheless , my learning this weekend is its all about MEDICARE whoever gets there first will have the biggest opportunity. Perhaps all of TROV collection of data and beta roll-outs at hospitals is about getting that Medicare checked off. anyway, that's my 2 cents. I now await for all the bashes , pumpers and know it all´s to respond.
once again in my humble opinion they are referring to the sample being as close to real time as possible which is awesome . yet the processing of the sample and documenting of data will take 2 weeks. regarding on site tests my understanding is that the hardware is sizable and needs to be operated by specialists. now , cold they follow a TTOO model and train hospital techincians to do it. perhaps but I don't think that is there model to many points of failure ( humans ) PS: I could be wrong about everything. anyway, have a great weekend..