New trial usually takes about 2-4 years. It can vary depending on the type of trial- whether it's a placebo controlled trial, randomised trial, double blind etc etc. . . In Spontans case it may be a single hand trial ( no pun intended) but can still take about 1-2years. This include designing the study, recruiting collaborators, ethics approval, actual study period, data collection, data analysis, publication etc. The cost varies hugely but 3-10 million is probable for a low cost trial involving 50- 100 patients.
The lesson i learnt MSB ( mesoblast) drama is that FDA may take their own time to reconsider your new proposal. It took about 4years for MSB to do another trial and get their first FDA approved product. Regarding SP- I think the market is pricing in the cost of the trial and time delay to get FDA approval. The cash hand will be depleted substantially by the time it's ready to resubmit for FDA approval. Then there is the uncertainty about whether we get the approval or not too.
i think LTP has a great product and great long term value but in the short term, SP likely to reach 30 c or lower but will be a multi bagger once it gets FDA approval.
LTP Price at posting:
43.5¢ Sentiment: Hold Disclosure: Not Held
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