How frustrating. My opinion on the current situation.MSB have...

How frustrating. My opinion on the current situation.

• MSB have stated the TH is in relation to the FDAs review of Ryoncil e.g. MSB has been notified on the outcome IMO. Nothing else is mentioned, so it is unlikely this relates to a deal or anything else as other posters have mentioned (not impossible but not probable). I also doubt there is a delay from the FDA.
• TH is in place on the Nasdaq & ASX, so they do not need to disclose if they have a CRL or approval until trading resumes. That's the purpose of a TH. Some posters have mentioned they have to release now, this is incorrect. They have to release before trading recommences, which is likely to be Monday.
• TH is expected to end Monday. It may be earlier, but the wording in the TH request indicates it is expected Monday.
• MSB would have prepared for likely scenarios, including announcements for approval. I find it unlikely they would have entered a TH today if they received unconditional approval. This is the easiest announcement to make and hence I don't think this bodes well.. But this is just an opinion, not based on fact.
• If a CRL has been issued, they will need time to digest reasons and to craft an adequate response. Unfortunately, I see this as the most probable scenario. Maybe I'm being a bit too pessimistic, but I am prepared for this outcome.
• If a conditional approval has been granted e.g. requesting post marketing study or a so called phase 4 trial, this may require further time for MSB to review and respond. This is my 'hopeful' outcome and would be a great result!
• If we start to see other FDA approvals for the 30th, I will get increasingly worried. Keep a watch out for this.

After the ODAC meeting my view was that we would get approval with a post market study required. This remains my hope. MSBs view on efficacy, KOL comments, ODAC result, unmet need, safety profile, & history in Japan all points to a favourable result. Against approval, the FDAs queries on manufacturing and efficacy during the ODAC meeting are still ringing in my ear. ahhhh having to wait until Monday is so frustrating.

Hope for the best but prepare for the worst. We will find out Monday at the latest.

GLTAH & hopefully we get positive news.