Maybe they will post the shareholder meeting slide
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Posted On: 05/28/2019 10:14:26 AM
Maybe they will post the shareholder meeting slides as they have done in the past.
Not sure on these three:
1) TNBC ODD: With TNBC ODD, I know there has been some confusion. But the last I remember is NP saying there applied maybe 60-70 days ago and will be checking on it.
Since they are after MOA in many cancers, and there is preclinical data with ccr5 inhibitors with many cancers, I wonder if the FDA will deny ODD for TNBC because the potential market size is much bigger than 200k or if they will stick with just TNBC and say yes.
2) Animal Preclinical Trials Preliminary Data -- I have not seen an update if they have started. I believe NP said in the CC that Colon IND for Phase 2 is not based on this data, but previous data. So maybe they haven't started, as you would think that would be the first one.
3) Monotherapy: IncellDx Dose/CCR5 Analysis Results. I not remember hearing anything new.
So maybe (if we don't get a pr this week), just to get discussion for June milestones started.
June
TNBC Phase 2 Trial: First Three Patients Injected at 350mg (stage 1 of 3+3)
Mono pivotal phase 3 trial FDA's response
Initiate mono pivotal phase 3 (on their list of milestones for June, but maybe July)
TO closes
FDA response to allow 525mg safety data with Combo
BLA Part 2 possible (with FDA approval of 525mg) June-July
Colon Cancer Phase 2 Trial IND Submission
Results from NASH mice study (possible but not certain)
Convertible note paid A BIG ONE (alps is dropping shares again this morning)
ASM Microbe 2019 June 21st
Prostate Cancer Test 510(k) filing
Not sure on these three:
1) TNBC ODD: With TNBC ODD, I know there has been some confusion. But the last I remember is NP saying there applied maybe 60-70 days ago and will be checking on it.
Since they are after MOA in many cancers, and there is preclinical data with ccr5 inhibitors with many cancers, I wonder if the FDA will deny ODD for TNBC because the potential market size is much bigger than 200k or if they will stick with just TNBC and say yes.
2) Animal Preclinical Trials Preliminary Data -- I have not seen an update if they have started. I believe NP said in the CC that Colon IND for Phase 2 is not based on this data, but previous data. So maybe they haven't started, as you would think that would be the first one.
3) Monotherapy: IncellDx Dose/CCR5 Analysis Results. I not remember hearing anything new.
So maybe (if we don't get a pr this week), just to get discussion for June milestones started.
June
TNBC Phase 2 Trial: First Three Patients Injected at 350mg (stage 1 of 3+3)
Mono pivotal phase 3 trial FDA's response
Initiate mono pivotal phase 3 (on their list of milestones for June, but maybe July)
TO closes
FDA response to allow 525mg safety data with Combo
BLA Part 2 possible (with FDA approval of 525mg) June-July
Colon Cancer Phase 2 Trial IND Submission
Results from NASH mice study (possible but not certain)
Convertible note paid A BIG ONE (alps is dropping shares again this morning)
ASM Microbe 2019 June 21st
Prostate Cancer Test 510(k) filing
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