Do you know if Cyclacel has met with the FDA regarding next step on SAP for RMDS? They were supposed to meet towards the end of the year and the end of the year is here. There are a lot of shorted shares that have yet to be covered. The only thing that will force their hand is any type of positive news. An expedited approval sure would be music to our ears.
Due, my understanding is that there have been ongoing "informal" discussions with the FDA about a phase 3 (or phase 4 cofirmatory in the case of AA} trial design. I think they are submiiting the "Final Published RMDS data" for additional consideration. If the FDA "suggests" they apply for AA, they will do so .I have no knowledge of time frames.
Based upon the doubling of survival times for SAP in RMDS and the unmet medical need, I believe there is a decent chance that the FDA would give CYCC an accelerated approval. IMO if this happened the stock would gap up to over $10 and could easily run to $20. Think about it. They would be completely in the driver's seat and and be in a sweet spot. The doubling of survival times was no fluke. It is a matter if the FDA wants to get a safe and effective cancer the drug out to a population that has no real alternative with post approval monitoring make everyone wait by a couple of years by making them jump through the hoops with a phase 3 trial. I have seen cancer drugs AAed with less of an unmet medical need with only p2 data and more serious side effects.