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$HMR or $HMRFF is going to be the big winner out of Brazil.. the purest white sand on earth.. the infrastructure government is upgrading.. the partnerships with Halocell and LOI with SiMex..
I love the reply's i woke up looked at my account oh the relic 5 years dead in OTC land.. UP...
figured id say what i had.. 4m shares just coasting along.
go TFZI hit $1
Are you guys back in this?
I get the feeling the covid tracing app stuff will come first and then this will catch fire.
Just a wild guess
I been a shareholder since mice. All star doctors.
Fast track appears to be something that can happen asap.
Unprecedented results for p5 and p6.
I found that sentence to be the most intriguing. If fast track is granted.. Then we get word of say MD Anderson... where Dr.Kamat is in Texas.
Maybe the warm months are in our favor to hit and pass targets
Anyone know anything about the NAVABLATE trial
All I read from fda website was that it's 60 days for a response to applications made as an 'add-on' or included in the IND.
That's where the 60 days comes.
What are the timelines for FDA to respond to a breakthrough therapy designation request?
FDA FAQ
22. FDA will respond to breakthrough therapy designation requests within 60 days of receipt of the request.
21. Can a sponsor submit a request for breakthrough therapy designation to a pre-IND?
A sponsor should submit a request for breakthrough therapy designation with the submission of a new IND, or as an amendment to an active IND. Requests for breakthrough therapy designation should not be submitted to pre-INDs, inactive INDs, or INDs that are on partial or complete clinical hold.
So the IND will lift the clinical hold.. and start that clock.. i have no clue on the 'results---granted' paradigm is in play or what the standards are.. if 20 or less?
would be a nice though to get the btd granted fully but again.. i dont know if that's even possible?
lol next quarterly is in July. With Mid May being a potential 'update'
IND 3 weeks
Then possible 60 day wait as the FDA has this thing about submitting Breakthrough designations while on clinical hold..
So that marks out the rest of this 1/2 year till about July
Maybe we get IND May + Patient data June + BTD July
IBOX for TLTFF outdated
This is the saddest thing.. either erase it or update it to reflect all the patents, optimizations, drug compounds TLD-1433, TLD-1633 1829 etc, grants (ORF)
I seriously cant believe Im looking at a bladder diagram with a balloon...
Tell ya what, if the moderators want, I volunteer to make it much better.
NAVIGATE Trial Complete Nov 1 2019, Updated Dec 9/2019
NAVIGATE TRIAL
NAVIGATE: Clinical Evaluation of superDimensionâ„¢ Navigation System for Electromagnetic Navigation Bronchoscopyâ„¢
1388 Patients
37 Hospitals
Observational
This study seems to look at all 'outcomes' post procedure and the viability to use as a diagnostic for lung lesions et al.
This is very exciting to me.. as reaching the Peripheral Lung Tumours is where the $$$ is at.
Medtronic is trying their ThermoAbalate or NAVABLATE which was pushed back to Aug 2020 for completion
NAVABLATE
Medtronic truely wants to make a breakthrough in Lung Cancer..
They may be one partnership or buyout away from doing it.. just need to find that perfect 'drug' match.
I am waiting till they release their results officially.
Anyone follow this?
Navigate + Navablate trials
Just wondering if anyone has info about these two trials.
They are set to be over Dec 2019 and April 2020.
Navigate
Navablate
There are some extremely good partnership potentials for their Lung technology if they can get the right drug
Just curious whats the opinions here.
Thanks
Start the leg up to TMX $2 or Nasdaq $4...
Rats were .78c(dec 2014) June 30 2014 and the shares were 79m so 61m cap.
Are we really saying that on a market cap basis 145m that we're a 65m cap with Phase 1 Exploratory Efficacy? (barely over Rats??)
Might be the most undervalued biotech of all time once 90 days hits..
Very tired of being in the pennies... Humans = Dolla Dollas.
What are the timelines for the results for lead drug?
Figure like any biotech.. results first then BO
I dont want to miss this potential.
Cheers.
Goes way beyond
Theralase Powerpoint
Page 6. the yellow part is the tumour cells... and what they found later was that even the stem cells or 'metastasis' that were undetectable previously.. and was speculated as the reason for recurrence... was being targeted by the drug.. thus the optimized procedure for P5 and P6 360+ day response one shot kill
Then Page 8.. add in China's market.. numbers go even higher.
90 days is a mark in history books..
July theres an FDA meeting asking for Phase 2 to be the 'marketing activities' or IMO Commercialization allowance.. that gets to be 'official'
Perhaps we see a similar jump to Endocyte
Endocyte global
and a CEO looking for cures might take interest after 90 days
Novartis wants to win
And so does this investor...
Good, im glad they're focused on opening new sites.. no problem.
PMH is a site already.. with its own bladder wing and Toronto Bladder Collaborative waiting to send patients over to PMH for treatment
Then if we have a small set treated.. and the FDA says yes to Phase 2 being final to commercialization..
then real investors can see real 3 month results in august with a fresh sign off.
The pdf doc says enrol and treat at Canadian sites Q2 2019
I think we're right there.
Plus we got our REB on April 25.. one day before the meeting on the 26th which puts into question exactly when they actually got the REB.. held back potentially
When are the results expected on phase 2? are their interim milestones?
I just look at the Phase 1.. they treated at PMH, 3 patients in 19 days.
So if they can ramp it up just a touch.. maybe 2 hospitals do 5 each before the AGM.. now we're talking a real 'data set'
But any number treated this month is a victory.
Means we've officially got the full dose optimized dfoc system ball rolling.
Remember 3 months we had unoptimized 1/2 dose 3/3 and all patients 6/6 were 100%
So Im expecting some stellar CR numbers out the gate.
Finally doctors will have the honour of stating legally, 'primary efficacy 3 month objective' met.. it works in humans.
if that doesn't get us to Nasdaq... i dont know what will
My math stinks 6.59*.3 is $1.97 for 10.6 patients
That's my starting point can we treat 10 in May super early June.
I think that's a victory
I like your breakdown, very accurate.
Ill divide by 3 again though. Because I'm interested in the first 'statistically significant' number between 10 and 15 patients.
32/3 is about 12 patients. Say 3 UHN hospitals start and treat 1/week for a month.. thats 12.
Cost for 12 patients steps 1,2,3 = 6.59*.3= $2.6
Terry Fox Grant winner is May 31st.
Honestly Id roll 12 this year to get the pps up to $4++
Roll out GBM Phase 1b
Uplist to Nasdaq then go USA and International with a full investment community behind us.
JMHO Never do more than you have to for maximum results
Let's consider the cost of the trial for the three locations, Canada, United States and Europe are equal. We can divide the projection by 3 representing each location. Now we look at Canada first.
Canadian Phase 2 trial costs ($CDN M)
Phase II NMIBC Study Drug Manufacture and Packaging 1.00 (3.0 /3=1)
Phase II NMIBC Study Device Manufacture and Packaging 1.00 (3.0/3=1)
Clinical Research Organization / Regulatory Approval 0.83 (2.5/3=.83)No credit given for Canadian approvals already complete.
Phase II NMIBC Clinical Study 2.16 (6.5/3=2.16)
WorkingCapital 1.60 (5.0/3=1.6)
Complete Canadian Trial Total 6.59 ($CDN M)
6.59($CDN M) divided by 3 represents 3 separate values to each of the three phases of the Canadian Phase 2 trial.
1. Intial 32 patient treatments ( 1st treatmet) 2.6 (6.59x.4)
2. 2nd patient treatment (6month from 1st treatment)1.97 (6.59x.3)
3. Study completion after 2nd treatment 1.97 (6.59x.3)
2.6 Million required for initial Roll out in Canada treating 32 patients with the 1st treatment.
This one has legs.
Hey Dogman1955
Just check'n in.. what's the timeline here for Phase 2?
Cheers.
Hey Dogman, just read some posts...
still a shot?
cheers
Any shot kgkg considers listing on CSE? Oct 2019 edibles are legal..
only ask cause i like the TFSA trading.
Cheers
Is this on the CSE exchange yet? Canadians want to know
I'll get this if tsx-v and .01
Run to $1 hahaha
Hope ur right about this one.....
what are u guys expecting out of this play just curious. hehehe
With Legalization coming we should get something here...
Hopefully a biggy
Any results here w the science?
information-medical-practitioners/information-health-care-professionals
This came out sept 13 i think but the revised is oct 12 it's a good document ehave may of been waiting for this official communication with practitioners about marijuana
still waiting for tsx-v
Still no tsxv
Maybe after legalization.
Who knows
Chart looks solid.
Options at .30c.
Any of these guys want $$$ the charts gotta move north
Praying for the govt contract and app launch before legalization.
Would love to see previous highs smashed.
Cant wait till october gets here.. seems that's the next push chart still looks good
3 weeks till legalization. I'm guessn early Oct will heat up.
People bought in at $1.08 so that's a min to me.
IMO
U called that good
Any particulars on that other than Wildflower's brand being strong IMO
2 pull back days then continue going up.. that's ok.
ema 20 is equal to ema 50
ma 20 crossed ma 50
technicals seem fine on this chart.
lol hopefully
Maybe Roger will start the CSE process asap.
Anything you guys talk about GRO3.. just look up Ravenquest.. they have the orbital gardens.. the roto gro copycat..
nuff said.