Suda signs deal with $936bn pharma company, page-7

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21/12/18

08:28

Post #: 36929167
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Originally posted by Buckland: ↑

What we need:

TEVA to obtain marketing approval for Zolpimist - they submitted the application back in December 2017 and get it to market as this will start the first milestone payment and flow of money from royalties and supply at cost plus agreed handling fees. (However does SUD have the upfront money that it will be required to supply the require amount of Zolpimist)
They could also give a estimate of revenue that will be generated from this deal in the short term.

Eddingpharm to give up date on when their application for Zolpimist will be submitted and estimated time for approval

For SUD to announce the reason behind the delay in obtaining approval for Artimist from TGA if Artimist is sold with out this approval imo this will be bad news.

Update on the planned meetings with FDA and WHO

Submitting of MAA in Australia for Zolpimist

Update on the outcome of the meeting as below

PERTH, AUSTRALIA – 25 May 2017: SUDA LTD (ASX: SUD), a leader in oro-mucosal drug delivery, today announces that that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted SUDA a meeting on 21 June 2017 to discuss the proposed plan for registration of SUDA’s novel ZolpiMist™ oral spray of zolpidem tartrate to treat insomnia in the UK and European Union.

The MHRA provides scientific advice to applicants on all aspects of development and registration of pharmaceuticals. SUDA is seeking advice on the suitability of its regulatory strategy which is to file for approval of ZolpiMist in Europe based on the data that successfully resulted in the product’s US FDA approval, together with a small pharmacokinetic study to compare ZolpiMist with Sanofi’s European brand-leading tablet of zolpidem tartrate, Stilnoct, in healthy adults.

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I do not want to be greedy but I would love a late Christmas present in the form of an announcement summarising the present cash flow situation, what deals have been done and how this will reflect on Suda going forward.

SUD Price at posting: 0.6¢ Sentiment: Buy Disclosure: Held
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Suda signs deal with $936bn pharma company, page-7

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