PLI’s share price jumped more than 12 per cent in trading Tuesday as investors reacted to the company’s reporting on its Type-C meeting with the FDA on its Ryplazim (plasminogen) manufacturing process, which had been put on hold as of March, 2018, due to an FDA request for a number of changes in ProMetic’s Biological License Application (BLA).
“We are pleased with the positive outcome of the Type C meeting regarding the plan that we submitted in response to the FDA’s list of items outlined in the CMC section of our Ryplazim™ BLA,” said Bruce Pritchard, ProMetic’s COO and CFO, in a press release on Tuesday. “As a result of the feedback received, we will now continue with finalizing the remaining steps necessary to proceed with the running of RYPLAZIM™ conformance batches.”
Sarugaser says that the FDA’s request in March materially disrupted the company’s anticipated ~$30 million in revenue for 2018 and ~$80 million in revenue projected for 2019, along with dashing the company’s hopes for a priority review voucher from the FDA to expedite Ryplazim’s review process.
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As a result of the delay, the analyst had trimmed his target from $4.25 to $1.75, and then again to $1.50, yet he expects that PLI should now be ready to resubmit its BLA in early 2019.
“We see this nod from the FDA as a critical, and extremely positive, first step down the path PLI intended to be walking six months ago,” says Sarugaser. “This is fundamentally good news for a company previously beleaguered by difficult regulatory interactions. Once PLI can effectively shore up its balance sheet by securing additional loans or issuing equity, we anticipate a re-establishment of value in the RyplazimTM (plasminogen) asset.”
Sarugaser’s $1.50 target represents a projected 12-month return of 206 per cent at the time of publication.
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