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TOPIC: Mai 23 Volume spike

Mai 23 Volume spike 24 May 2017 04:20 #9361

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When you look at this chart (on site) you see the spike starting at roughly 3.10 p.m.

I do not understand why this happens. Is this when a high frequency trading system smells blood and takes off? I mean there must be a trigger somewhere?

Anybody?
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Mai 23 Volume spike 24 May 2017 07:37 #9362

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FAS

Possible trigger for buying interests from big money managers: statisticians might have been consulted for probability of clinical success (it took the whole morning to make up the mind).

I think site selection, study monitoring, data verification for case report forms vs source documents, case report cleanup are all done inhouse (low cost and there are only 20 sites and the duration of the study is long with only sporadic rushes) and all these have been ongoing since the very beginning of the study. As you have said, biostatistics are done by an outside consultant to make the integrity of the study results more respectable.

I think some key people inside the company know the data well all along and the so-called initial data readout may come near to the end of the 2nd Q.

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Mai 23 Volume spike 24 May 2017 08:38 #9363

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Later in the day, usually from 2pm on is often ruled by the bigger fish.
However, once a volume spike starts, it will light up many "trading" boards. Who in turn, may also jump in.
We have seen these mysterious spikes and runs before.
This time we know hard data is coming.

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Mai 23 Volume spike 24 May 2017 12:08 #9364

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Biostatistics for a pivotal trial is more complicated than for a phase 1/2 trial. Even I can do phase 1 data analysis for a cancer trial.

For a pivotal trial, the raw material is the completed CRFs (case report forms - they used to be hand entered by the study nurse or someone like that and verified by a CRA, clinical research associate). Today, many of these works are done entirely through a computer/lab tops or assisted through a computer/lab tops and feed into a central computerized depository (data entry). Should be any discrepancies or inconsistancies or questions, they can be resolved by phone calls or online with the study sites (through the CRAs).

After the data entry is completed, the data will be tabulated for analyses, including graphic displays, etc. If the data set is clean, the preliminary analyses would take a short time. There are many, many ways to look at all the data and draw a conclusion or many conclusions.

Based on earlier stem cells therapy studies for scleroderma with and without cytoxan, the one year data is better than the two year data and the 48 month data should follow the same trend as that from the 24 month. As Hedrick has indicated in the first Q questions and answers session, placebo effects for this kind of clinicals are uncommon. I think Hedrick has seen the STAR data all along.

Afterthoughts: Regardless what kind of analyses a company would perform, FDA would make their own analyses after PMA is filed. FDA would also perform clinical sites inspection when approval is close. Likewise for lipo doxo (EU would coordinate activities with the FDA) the San Antonio manufacturing site will need an inspection. Many US manufacturers would ususally ask the FDA to do a GMP inspection whne the plant has been fully set up -I think this step has already been done, so only EU inspection is needed in this case. As part of the ANDA approval, CYTX has to submit to EU (but not to the FDA if approval is only for the EU) sample injectables, package insert, label, etc - EU will do their own sample analyses.

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