Hi All,
There have been some comments concerning the upcoming timelines for the OSA - Sleep Apnoea results and the Nasdaq Listing.
Some of the following have been the main issues
1. It is preferable to List on the NASDAQ first and then release the OSA results to get the best exposure in the USA and SP appreciation.
2. With ASX Rules requiring the immediate release of results some posters have cautioned that the OSA results may need to be released firstly before the NASDAQ listing.
3. The SEC requirements may delay the listing beyond the aspiration of February and make the Novotech Report due sooner than later.
Now,
what if the BOD had some control over when the Novotech Report was released.??Could IHL coordinate its Final Sign-Off with Novotech according to its desired listing timeline??The Novotech Report appears to have some intervals of consultation with IHL
>
1st Draft Review
> 2nd Draft Review
> Final Sign-offHere is part of the Novotech Contract with IHL, please check it and see if I am reading this correctly.
https://docoh.com/filing/1873875/0001213900-22-003395/IXHL-20FR12B/file/14
Clinical Study Report (CSR)
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| 89) | Novotech will be responsible for development of the CSR. Novotech Medical Writer will join the initial team kick-off meeting with the PM and Incannex team to confirm service expectations and timelines. |
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| 90) | Novotech will produce the CSR using standardized content templates that comply with all ICH and regional structure and formatting requirements. |
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| 91) | Novotech will develop a shell clinical study report in accordance with protocol requirements and ICH E3 standards for review by Incannex. |
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| 92) | Following finalisation of the TFLs, Novotech will prepare a first draft CSR which will be sent to Incannex for review, comment and/or approval. Incannex will provide consolidated comments to Novotech for incorporation into the final draft. |
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| 93) | A second draft version of the CSR will then be issued to Incannex for review to ensure Novotech have correctly incorporated Incannex’s required changes. It is expected that only minor changes related to the previous review will be required at this time. Any major changes or amendments required to the final draft CSR, may be invoiced on a timesheet basis. |
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| 94) | Novotech will finalise the CSR and following internal QC, the final CSR will be issued for the site’s PI and Incannex approval and final sign off. Following sign off of the CSR, Novotech will format the CSR. |
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| 95) | Any additional changes and subsequent reviews to the CSR and/or any changes that require changes to the statistical analysis output and by definition changes to the SAP will be subject to timesheet cost invoicing to Incannex by Novotech. |
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